How do I compare vitiligo treatment options?

Twelve options and the same twelve questions asked of each one, with no score, no ranking and nothing that picks for you.

Put two or three options side by side

When direct head-to-head evidence is absent, the matrix says so. “Not established” is not zero benefit or zero risk. Open a named profile for the full sources, population details, and limits. Missing-information labels have distinct meanings: “Not applicable” means the question does not fit that option; “Not reported in the reviewed source” means the source did not provide it; “Not established by the reviewed evidence” means the evidence cannot support the conclusion; and “Not yet reviewed” means I have not finished that evidence check.

Vitiligo choices, compared without ranking or recommendation
Same question for every optionNo active treatment nowCamouflage or non-medical supportTopical corticosteroidsProtopic or generic tacrolimusOpzelura (ruxolitinib) creamNarrowband UVBRinvoq (upadacitinib)Litfulo (ritlecitinib) - investigational for vitiligoPovorcitinib - investigationalA clinical trial or emerging medicineRECELL procedural packageMonobenzone final depigmentation
What is its status, and when was that checked?A patient choice. No medicine or device approval applies. Checked August 2026. Evidence EvidenceSupportive or cosmetic path; not a vitiligo medicine approval. Checked August 2026. EvidenceDiscussed in vitiligo guidelines; exact products do not have a specific US vitiligo indication. Checked August 2026. EvidenceUS vitiligo use is off-label. Generic tacrolimus ointment is available. Checked August 2026. EvidenceUnited States: FDA-approved for a defined nonsegmental-vitiligo population; checked August 2026. European Union: authorised on 19 April 2023 for non segmental vitiligo with facial involvement in adults and adolescents from 12 years of age, a narrower population than the US one; checked 17 August 2026. Great Britain: not established in the reviewed records. Each jurisdiction stands on its own. Evidence EvidenceEstablished clinician-directed phototherapy used in clinic or at home; device and jurisdiction rules differ. Checked August 2026. EvidenceEU-authorized for adults and adolescents age 12 years and older with nonsegmental vitiligo who are candidates for systemic therapy; not in current US or UK vitiligo labels. Checked August 2026. Evidence Evidence EvidenceApproved for severe alopecia areata, not vitiligo, in the current US, EU, and Great Britain product information. Vitiligo filings are planned, not decided. Checked August 2026. Evidence Evidence Evidence EvidenceThe reviewed trial and manufacturer records describe a vitiligo research candidate and do not establish authorization in every jurisdiction. Incyte plans future filings; a positive trial and filing plan are not approval. Checked August 2026. Evidence Evidence EvidenceResearch status depends on the exact candidate, protocol, location, and date. Trial completion or topline news is not approval. Evidence EvidenceFDA PMA-approved for selected stable adult lesions in a defined professional setting; current EU or UK vitiligo scope was not established by the sources reviewed. Checked August 2026. EvidenceHistorical US approval record; branded Benoquin no longer manufactured or distributed; compounded product is not FDA-approved. Checked August 2026. Evidence Evidence
What goal and mechanism does it address?Avoid active-treatment burden now while keeping supportive care and future review available. Evidence EvidenceChange appearance now, support confidence or coping, or make a situation easier without claiming to change vitiligo. EvidenceCalm local inflammation where a clinician thinks a topical medicine fits the patch and goal. EvidenceA steroid-sparing topical path that changes local immune signaling. Evidence EvidenceBlock local JAK signaling in treated skin to support repigmentation. Evidence EvidenceUse a defined band of ultraviolet light to influence skin immune activity and support repigmentation. EvidenceChange JAK–STAT immune signaling throughout the body. Evidence EvidenceChange JAK3 and TEC-family immune signaling throughout the body. EvidenceSelectively change JAK1 immune signaling throughout the body. EvidenceAnswer a defined research question about benefit, harm, mechanism, or delivery. Evidence EvidenceTransfer a suspension of a patient’s pigmented skin cells to laser-prepared stable patches. Evidence EvidencePermanently remove remaining pigment in extensive vitiligo rather than restore color. Evidence Evidence
What kind of evidence supports it, and can it be compared directly?Guideline and patient-education context. Comparability: not directly comparable with a biological treatment outcome. Evidence EvidenceGuideline and patient-support context. Comparability: not directly comparable with repigmentation outcomes. EvidenceGuideline and product-specific study context. Comparability: indirect across products and trials. EvidenceGuideline and heterogeneous review evidence. Comparability: indirect; not interchangeable with Elidel (pimecrolimus) or other topicals. Evidence EvidenceTwo randomized vehicle-controlled trials and current label. Comparability: direct versus vehicle, indirect versus other treatments. Evidence EvidenceClinical guidelines and varied trials. Comparability: direct only within an exact study; otherwise indirect. EvidencePeer-reviewed randomized phase 2 plus sponsor-reported randomized phase 3 results. Comparability: direct versus placebo; indirect versus other treatments. Evidence EvidencePeer-reviewed randomized phase 2 plus manufacturer phase 3 topline. Comparability: direct versus placebo within its studies; indirect versus every other option. Evidence EvidencePeer-reviewed randomized phase 2 plus manufacturer phase 3 topline. Comparability: direct versus placebo within its studies; indirect versus every other option. Evidence EvidenceProtocol and emerging results vary. Comparability: unknown until the exact trial design and comparator are reviewed. Evidence EvidenceSmall randomized within-person pivotal device study. Comparability: direct for the complete package versus matched control, not cells alone. Evidence EvidenceArchived label and very small retrospective series. Comparability: not comparable with modern repigmentation trials. Evidence Evidence
Who and which body sites were studied?No trial population applies to the choice itself. Vitiligo course still varies by person and body site. Evidence EvidenceSupport needs are individual. Product-specific body-site and skin-sensitivity evidence varies. EvidenceEvidence varies by exact steroid, formulation, age, body area, extent, and combination. EvidenceStudies vary by age, body site, formulation, follow-up, and whether light treatment was included. Evidence EvidencePeople meeting the labeled trial criteria; facial and total-body outcomes were reported, with population limits. Evidence EvidenceEvidence spans multiple patterns and sites, but response differs by body area and study population. EvidencePhase 2 adults and phase 3 adults and adolescents with nonsegmental vitiligo; face and total body, not reliable individual-site estimates. Evidence EvidencePhase 2: 364 treated adults with active nonsegmental vitiligo; stable-only disease was excluded. A sponsor-linked analysis reported group outcomes for Fitzpatrick types I–III and IV–VI. Phase 3 included adult and adolescent and separate adult study populations, but full result tables remain unavailable. Evidence Evidence Evidence EvidencePhase 2: 171 adults with extensive nonsegmental vitiligo and limited demographic diversity. A descriptive follow-up reported subgroup and body-region outcomes for 103 people. STOP-V1 lists 467 adults and STOP-V2 lists 450; full phase 3 subgroup tables remain unavailable. Evidence Evidence Evidence EvidenceOnly people meeting the exact eligibility rules; body sites and endpoints depend on the protocol. Evidence EvidenceTwenty-five adults with stable focal, segmental, or generalized vitiligo; selected sites and notable exclusions. Evidence EvidenceThe historical label describes disseminated idiopathic vitiligo affecting more than half of body surface; modern demographic and body-site reporting is inadequate. Evidence Evidence
What possible benefit was reported?Avoids treatment burden and unwanted risk now. It does not aim to restore pigment or stop change. Evidence EvidenceCan offer immediate, optional appearance control or emotional support. EvidenceSome studied topical-steroid plans improved repigmentation for some groups. Evidence EvidenceReview evidence supports discussing repigmentation in selected contexts; averages do not predict a patch. Evidence EvidenceAt week 24, TRuE-V1 total-body response was 20.6% of 221 people versus 5.1% of 109 on vehicle cream; facial response was 29.8% versus 7.4%. TRuE-V2 total-body response was 23.9% of 222 versus 6.8% of 109; facial response was 30.9% versus 11.4%. Total-body means at least 50% score improvement; facial means at least 75%. These are the sponsor’s posted registry tables. The current US label prints the facial figures as 29.9% versus 7.5% and 29.9% versus 12.9%, counting a slightly larger TRuE-V2 population. Most people reached neither bar. Evidence Evidence EvidenceCan support repigmentation for some people and sites; no result is guaranteed. Evidence EvidenceAt week 48, Study 1 total-body response was 19.4% of 206 people versus 5.9% of 102 on placebo; facial response was 25.2% versus 5.9%. Study 2 total-body response was 21.5% of 205 versus 5.9% of 101; facial response was 23.4% versus 6.9%. Total-body means at least 50% score improvement; facial means at least 75%. These are sponsor-reported topline results. Evidence EvidenceAt week 24, four of five active phase 2 arms had statistically significant differences from placebo, with three distinct mean facial-score improvements: 21.2% in two arms, 18.5%, and 14.6%, versus 2.1% worsening with placebo. Pfizer says two phase 3 studies met facial and total-body endpoints but did not release response percentages. Evidence EvidencePhase 2 mean total-body improvement ranged from 15.7% to 19.1% versus 2.3% worsening with placebo. In a post hoc week-52 follow-up without a placebo comparator, VASI50 ranged from 25.8% for feet to 57.3% for head and neck outside the face. Sponsor-reported phase 3 F-VASI75 (at least 75% facial-score improvement) was 18.9% versus 6.8% and 18.9% versus 3.1%. Evidence Evidence EvidencePossible personal benefit is uncertain and is not the same as the study’s scientific value. Evidence EvidenceAt week 24, 9 of 25 RECELL areas versus 0 of 25 controls reached at least 80% repigmentation; 14 of 25 versus 3 of 25 reached more than 50%. No studied area reached complete repigmentation. Evidence EvidenceSubstantial or complete depigmentation occurred for some people in a small uncontrolled series; uniformity is not predictable. Evidence Evidence
What material harms or limits matter?Vitiligo may continue to change, and distress or practical needs can remain. Evidence EvidenceProducts may irritate, transfer, mismatch, or create time and cost burden. Support can be a poor fit too. EvidenceLocal skin change and possible systemic effects depend on product, body area, amount, and duration. Evidence Evidence EvidenceBurning or itching, a boxed warning, and ultraviolet precautions need exact-label review. EvidenceThe label carries boxed warnings and skin-cancer and ultraviolet-exposure precautions; evidence contexts differ across warnings. EvidenceBurning and other skin or eye risks require exact-device precautions, reaction guidance, and oversight. EvidenceUS boxed warnings include serious infection, malignancy, cardiovascular events, thrombosis, and mortality; known hypersensitivity is a US contraindication. EU restrictions also include serious infection, severe liver problems, and pregnancy. These are not personal rates. Evidence EvidenceThe current alopecia label carries boxed warnings for serious infection, mortality, malignancy, cardiovascular events, and thrombosis. It is a safety boundary, not a vitiligo event rate or personal estimate. Evidence EvidencePhase 2 reported similar incidence of grade 3 or higher treatment-emergent adverse events across groups and no new signal, but the reviewed sources do not supply a complete labeled contraindication, warning, interaction, or long-term safety profile. Evidence Evidence EvidenceKnown, suspected, and unknown risks; randomization, placebo, washout, or stopping rules may apply. Evidence EvidenceContraindications include hypersensitivity to trypsin or Hartmann’s solution; skin-sample collection has additional anesthetic and antiseptic hypersensitivity limits. Donor wound, laser, scar, infection, itching, redness, hypertrophic scar, Koebner phenomenon (patches where previously unaffected skin was injured), and possible worsening also matter. Evidence EvidenceUse for another condition and prior sensitivity or allergy are label contraindications. Permanent, distant, excessive, uneven, or unacceptable change, irritation, sensitization, long-term unknowns, and lifelong sun sensitivity also matter. Evidence Evidence
What follow-up or monitoring does it require?Agree on what changes, symptoms, or priorities should bring an earlier review. Evidence EvidenceNotice irritation and practical fit; remove camouflage when a clinician needs to examine or photograph the skin. EvidenceA written plan and review point are needed, especially for sensitive areas or broader use. Evidence Evidence EvidenceReview local reactions, body area, total plan, and any ultraviolet-treatment conflict. EvidencePrescriber review of health history, treated area, reactions, response, and label precautions. EvidenceClinician-directed device plan, reaction observation, eye and skin precautions, records, and review. EvidenceSpecialist screening, laboratory monitoring, vaccination and interaction review, and continuing follow-up. Evidence EvidenceSpecialist infection and tuberculosis screening, blood-count monitoring, vaccination and interaction review, and continuing follow-up under the current label boundary. Evidence EvidenceResearch-protocol screening, tests, visits, reporting, and investigator contact. A future commercial monitoring plan is not established. Evidence EvidenceProtocol visits, tests, reporting, and investigator contact routes. Evidence EvidenceStability assessment, trained center, wound and donor-site care, phototherapy coordination, and follow-up. Evidence EvidenceSpecialist consent, identity and psychological support, product verification, skin review, and long-term protection. Evidence Evidence
What practical burden comes with it?No treatment routine. Skin protection, support, or occasional review may still matter. Evidence EvidenceProduct matching, application, removal, appointments, or emotional work vary. EvidenceRepeated application and attention to the exact product and area. EvidenceRepeated ointment use, texture preferences, and follow-up. Evidence EvidenceRepeated cream use and follow-up; broader body involvement can make topical use impractical or outside the label. Evidence EvidenceRecurring clinic travel or home-device routine, positioning, records, and follow-up. EvidenceSystemic medicine, labs, infection vigilance, health-history coordination, and access work. Evidence EvidenceSystemic medicine, tests, infection vigilance, health-history coordination, appointments, and uncertain access. Evidence Evidence EvidenceTrial eligibility, randomization or placebo, visits, tests, travel, uncertainty, records, and possible lack of direct benefit. Evidence EvidenceTravel, visit schedule, uncertainty, procedures, records, and the possibility of no direct benefit. Evidence EvidenceProcedure, donor site, laser, dressings, recovery, later phototherapy, travel, and follow-up. Evidence EvidenceProlonged uncertainty, repeated topical use, permanent identity change, protection, follow-up, and possible later procedures. Evidence Evidence
What access or cost uncertainty remains?No treatment cost applies. Supportive care and appointment access can still carry cost. Evidence EvidenceOften self-paid; skilled matching and culturally safe support may be hard to find. EvidenceMany products exist, but price, formulary, quantity, and coverage vary. EvidenceNot yet reviewed: a current personal-cost snapshot. Generic availability can help, but quantity, formulary, and authorization vary. Evidence EvidencePrescription coverage, authorization, quantity limits, assistance terms, and personal cost vary. EvidenceClinic capacity, prescription, device status, supplier, coverage, and home setup can limit access. EvidenceEU authorization does not guarantee reimbursement; US and UK vitiligo use is off-label unless status changes. Evidence Evidence EvidenceVitiligo access is research or off-label unless a regulator later authorizes it; coverage and continued access are not guaranteed. Evidence Evidence Evidence EvidenceResearch access depends on a site and eligibility. Approval, commercial supply, coverage, personal cost, and post-trial access remain unresolved. Evidence Evidence EvidenceSite availability and eligibility control access; participation should not require buying the investigational product. Evidence EvidenceLimited centers; facility, device, laser, aftercare, and phototherapy coverage and cost vary. Evidence EvidenceMay depend on compounding with formulation-quality, supply, legal, coverage, and cost uncertainty. Evidence Evidence
What is known about combinations?Not applicable. There is no active intervention to combine; support, camouflage, and later treatment discussions can remain available. Evidence EvidenceCan coexist with treatment or no treatment when product and clinical instructions are reconciled. EvidenceSome exact steroid-plus-light plans were studied; evidence cannot be transferred to every steroid or device. Evidence EvidenceGuidelines discuss selected supervised combinations; the US label carries ultraviolet precautions that the team must reconcile. Evidence EvidenceExploratory add-on NB-UVB evidence does not establish combination superiority; the current label does not supply a combination plan. Evidence EvidenceSeveral exact combinations have been studied, but findings do not transfer to another medicine, device, or sequence. EvidenceA narrowband-UVB substudy is registered; no combination result was posted when reviewed. EvidenceAn add-on extension compared 43 people with 187 receiving medicine alone. F-VASI75 favored the combination in an observed-case analysis but not significantly after last observation was carried forward; the asymmetric stopping rule and unequal groups prevent a superiority claim. EvidenceThe reviewed studies compare povorcitinib with placebo. A controlled NB-UVB combination result was not verified, so separate evidence cannot be joined. Evidence Evidence EvidenceOnly combinations named in the protocol are studied. Separate evidence cannot be joined. Evidence EvidenceThe evidence is for laser preparation plus RECELL with later NB-UVB, not RECELL in isolation. Evidence EvidenceNo standardized combination with procedures or other agents is established by the reviewed evidence. Evidence
What is reversible, permanent, or still unknown?The choice is reversible, but changes that occur while waiting may not be. Evidence EvidenceNot reported in the reviewed source: product-specific long-term effects. The choice is usually reversible; confidence, identity, and preferred use can change by setting. EvidenceNot established by the reviewed evidence: the best product for a particular site. Treatment is usually stoppable with clinician guidance. EvidenceStoppable with clinical guidance. Product-specific long-term and body-site questions remain. Evidence EvidenceStoppable with clinical guidance. Individual durability, body-site response, and long-term questions remain. Evidence EvidenceSessions can be held or stopped by the team; response, durability, and burden vary. EvidenceStopping does not erase every risk. Long-term and body-site-specific vitiligo evidence remains incomplete. Evidence EvidenceStopping does not erase every risk. Full phase 3 percentages, long-term safety, durability, and reliable individual-body-site results remain missing. Evidence Evidence Evidence Evidence Evidence EvidenceFull peer-reviewed phase 3 results, complete safety tables, durability, phase 3 subgroup results, reliable individual-site predictions, regulatory decisions, and commercial access remain missing. Evidence Evidence Evidence Evidence EvidenceYou can ask about leaving; later access and benefit after the study may be uncertain. Evidence EvidenceProcedure effects are less reversible; color match, scarring, durability, excluded sites, and long-term outcomes remain uncertain. Evidence EvidenceOften irreversible; uneven change, regret, distant depigmentation, and later pigment return cannot be ruled out. Evidence Evidence
What would I ask before deciding?What should I watch? What support is available? When should we revisit the choice? Evidence EvidenceWhat am I trying to make easier? Is this product safe for the area? What support fits me? EvidenceWhich exact product and area? What is off-label? What local and systemic risks matter? EvidenceWhy tacrolimus for this area? How does the boxed warning apply? Who reconciles any light treatment? Evidence EvidenceDo I fit the label and study population? What outcome matters? How do warnings and body-area limits apply? Evidence EvidenceWhy this setting and device? Which areas are realistic? What is the reaction and contact plan? EvidenceIs systemic treatment proportionate to my goal? Which risks matter? What is approved and covered here? Evidence EvidenceIs this research or off-label here? Where are the full phase 3 tables? Which label risks and monitoring apply to me? Evidence Evidence Evidence Evidence Evidence EvidenceWhat protocol and post-trial access apply? Where are the full phase 3 tables? What safety facts are observed, excluded, or unknown? Evidence Evidence Evidence EvidenceWhat phase and comparator? What happens if I leave? Who pays? What care and results do I receive? Evidence EvidenceAre my patches stable and represented? Is the model authorized here? What is the complete package and written cost? Evidence EvidenceWhat is permanent? Who verifies the product? What if I regret it or change is uneven? What alternatives remain? Evidence Evidence

Options and detailed guides

Open a guide for its full evidence boundary. The matrix repeats source links in each cell so a regulatory fact is not mistaken for an outcome or a practical inference.

Start with what you want help with

These four paths are equal starting points, not a treatment ladder. Your priorities can change.

Slow or stabilize change

Ask what evidence addresses activity, what is inferred, and how progress would be judged.

Camouflage or non-medical support

Appearance control, coping, and practical support can matter without claiming to treat vitiligo.

No active treatment now

Waiting can be a deliberate choice, with support, acceptance, and a plan for when to review.

I have several options. Where do I start?

Start with the goal that matters to you. Then place two or three realistic options side by side using the same questions. Your choices stay only in this browser tab. They are not written to the URL, storage, analytics, a profile, or a network request. The comparison cannot interpret your history, score suitability, or choose a winner. Evidence Evidence Evidence

Why this matters

  • Sources cited, not yet graded

I ask the same twelve questions of every option, so one is not described only by possible benefit while another is described mainly by harm. Waiting, camouflage, and supportive care belong in the comparison when they match your goal; they are not lesser choices because they do not seek repigmentation.

Considerations

  • Depends on you

A fair comparison still depends on current evidence that applies to your situation, and it cannot capture every personal priority. There is no universal formula for how you should weigh benefit, harm, burden, and uncertainty.

Questions for your clinician

  1. Which two or three options are actually realistic for me?

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  2. What goal are we trying to meet?

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Evidence behind this page

Sources

Each evidence badge opens the source and its limits. The full list stays available here.

  1. U.S. Food and Drug AdministrationRegulatory · Regulatory / guideline, tier 1Independent source
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports the distinction between discovery, preclinical research, clinical research, FDA review and post-market monitoring in U.S. product development.

    What it does not support

    It is a high-level process overview, not a verdict on a specific emerging therapy, a statement that every research stage succeeds or a substitute for the current product label.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  2. ClinicalTrials.gov, U.S. National Library of MedicineTrial registry · Supporting research, tier 3Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: ClinicalTrials.gov and the National Library of Medicine host the record. The study sponsor supplies the registered study information, so the host name does not make the trial independent.

    What this source supports

    Supports a sponsor-run phase 3 study of oral ritlecitinib in people age 12 or older with active or stable nonsegmental vitiligo.

    What it does not support

    The registry reports 607 participants, registered facial and total-body outcomes, completed status, and no posted results. A completed trial is not an FDA vitiligo approval, a published benefit-risk conclusion, a recommendation, or evidence that the medicine is available for vitiligo outside research or off-label care.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  3. European Commission Union Register of medicinal productsRegulatory · Regulatory / guideline, tier 1Independent source
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports the European Commission authorization decision dated July 24, 2026.

    What it does not support

    The authorized vitiligo population is adults and adolescents age 12 years and older with nonsegmental vitiligo who are candidates for systemic therapy. It does not establish US or UK approval, individual suitability, comparative superiority, access or an individual treatment plan.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  4. European Medicines AgencyRegulatory · Regulatory / guideline, tier 1Independent source
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports the EMA safety overview, including EU restrictions concerning tuberculosis or another serious infection, severe liver problems, pregnancy, and additional caution when no suitable alternative exists for older adults or people with cardiovascular or cancer risk. It does not calculate personal risk, establish reimbursement, or supply a vitiligo regimen.

    What it does not support

    The product-information document linked from this page was dated before the July 24, 2026 vitiligo authorization decision and must not be treated as the source of the new vitiligo indication.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  5. DailyMed, U.S. National Library of MedicineRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: The National Library of Medicine hosts DailyMed. The product company submits the label to FDA, so it is authoritative for current US labeling but not independent efficacy evidence.

    What this source supports

    Supports the current US indications and boxed safety information.

    What it does not support

    Vitiligo is not among the current US indications. The label does not settle a pending application, establish approval elsewhere or create a vitiligo treatment plan.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  6. PfizerManufacturer document · Manufacturer, tier 4Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: Pfizer manufactures Litfulo, sponsored the studies and reported the topline results before full peer-reviewed results were available.

    What this source supports

    Supports the manufacturer-reported result that two Phase 3 studies met prespecified facial and total-body endpoints, the stated program size of 2,174 participants across 271 sites, and planned global adult regulatory filings; exact response percentages were not released.

    What it does not support

    It is not peer-reviewed evidence, a regulatory decision, proof of comparative superiority or an approved vitiligo indication.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  7. Journal of the American Academy of Dermatology (Ezzedine K, et al.)Randomized trial · Clinical research, tier 2Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: Pfizer sponsored the study; several authors were Pfizer employees or consultants, and other authors disclosed company relationships.

    What this source supports

    Supports the randomized phase 2 design, 364 treated adults with active nonsegmental vitiligo, group-level facial outcome, reported study safety through the extension, and the explicit exclusion of people with stable-only vitiligo.

    What it does not support

    The sponsor-linked trial does not establish a vitiligo approval, direct superiority over another treatment, stable-vitiligo outcomes, reliable results for every body site, long-term safety or an individual result.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  8. Experimental Dermatology (Peeva E, et al.)Observational study · Supporting research, tier 3Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: Pfizer sponsored the underlying study; several authors were Pfizer employees and other authors disclosed company relationships.

    What this source supports

    Supports a sponsor-linked analysis of the phase 2 population by Fitzpatrick skin type, including 247 people in types I–III and 117 in types IV–VI, group-level facial-score changes through the extension, and similar reported treatment-emergent-event patterns across those groups.

    What it does not support

    The analysis does not establish equal response for every skin tone, race or ethnicity, explain an individual result, supply phase 3 subgroup evidence, establish a vitiligo approval or replace body-site-specific evidence.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  9. ClinicalTrials.gov, U.S. National Library of MedicineTrial registry · Supporting research, tier 3Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: ClinicalTrials.gov hosts the record, while Pfizer sponsors the study and supplies the registered information.

    What this source supports

    Supports the adult randomized phase 3 design, active and stable nonsegmental-vitiligo population, current enrollment record, study status, registered facial and total-body outcomes, and absence of posted result tables when reviewed.

    What it does not support

    Registration is not peer review, a regulatory decision, proof of benefit, an explanation for differing public enrollment counts or a personal treatment plan.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  10. DailyMed, U.S. National Library of MedicineRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: The National Library of Medicine hosts DailyMed. The product company submits the label to FDA, so it is authoritative for current US labeling but not independent efficacy evidence.

    What this source supports

    Supports Litfulo identity, its current US severe-alopecia indication, boxed warnings, contraindication and other label safety boundaries. Vitiligo is not among the current US indications. Also supports the recommended dosage for the approved indication: 50 mg orally once daily, with or without food, with no loading dose or titration.

    What it does not support

    The alopecia label does not establish a vitiligo indication, vitiligo-specific event rates, individual suitability, coverage, a vitiligo regimen or approval in another jurisdiction.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  11. European Medicines AgencyRegulatory · Regulatory / guideline, tier 1Independent source
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports the current European Union severe-alopecia indication and European safety overview. The reviewed European product information does not include a vitiligo indication.

    What it does not support

    It does not establish a later vitiligo decision, national reimbursement, a vitiligo regimen, individual suitability or status outside the European Union.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  12. electronic Medicines Compendium / Pfizer LimitedManufacturer document · Manufacturer, tier 4Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: The electronic Medicines Compendium hosts company-supplied UK product information. It is useful for current listed indications but is not independent clinical evidence.

    What this source supports

    Supports the severe-alopecia indication in the current Great Britain product information reviewed by SteadySkin. It does not list vitiligo.

    What it does not support

    Company-supplied product information does not prove that no later MHRA decision exists, establish status outside Great Britain or provide independent vitiligo evidence.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  13. Journal of the American Academy of Dermatology (Yamaguchi Y, et al.)Observational study · Supporting research, tier 3Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: Pfizer sponsored the study; several authors were Pfizer employees and the comparison arose within a sponsor-run extension.

    What this source supports

    Supports an exploratory extension in which 43 people received add-on narrowband UVB and 187 received ritlecitinib alone, with differing results across missing-data analyses.

    What it does not support

    The small, non-randomized add-on comparison used a stopping rule only in the combination group. It does not establish combination superiority, a routine sequence, a self-directed light plan or individual suitability.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  14. Journal of the American Academy of Dermatology (Pandya AG, et al.)Randomized trial · Clinical research, tier 2Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: Incyte sponsored the study; several authors were Incyte employees or shareholders, and other authors disclosed company relationships.

    What this source supports

    Supports the randomized phase 2 design, 171 adults with extensive nonsegmental vitiligo, group-level total-body outcome, continued improvement in the extension, reported study safety and the explicit limitation of limited demographic diversity.

    What it does not support

    The sponsor-linked trial does not establish approval, direct superiority over another treatment, every body-site outcome, a full commercial-product safety profile, long-term safety or an individual result.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  15. Advances in Therapy (Passeron T, et al.)Observational study · Supporting research, tier 3Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: Incyte sponsored the underlying study; several authors were Incyte employees or shareholders and other authors disclosed company relationships.

    What this source supports

    Supports a descriptive post hoc analysis of 103 extension-evaluable adults who received povorcitinib throughout the phase 2 study, including subgroup reporting and week-52 VASI50 response proportions ranging from 25.8% for feet to 57.3% for head and neck outside the face.

    What it does not support

    The small pooled extension analysis was post hoc, descriptive and lacked a placebo comparator at week 52. It does not establish a reliable individual body-site prediction, phase 3 subgroup results, comparative superiority, approval, long-term safety or a personal treatment plan.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  16. ClinicalTrials.gov, U.S. National Library of MedicineTrial registry · Supporting research, tier 3Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: ClinicalTrials.gov hosts the record, while Incyte sponsors the study and supplies the registered information.

    What this source supports

    Supports the adult randomized phase 3 design, nonsegmental-vitiligo eligibility, 467-person enrollment record, study status, registered facial outcome and absence of posted result tables when reviewed.

    What it does not support

    Registration is not peer review, a regulatory decision, a published benefit-risk conclusion or a personal treatment plan.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  17. ClinicalTrials.gov, U.S. National Library of MedicineTrial registry · Supporting research, tier 3Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: ClinicalTrials.gov hosts the record, while Incyte sponsors the study and supplies the registered information.

    What this source supports

    Supports the adult randomized phase 3 design, nonsegmental-vitiligo eligibility, 450-person enrollment record, study status, registered facial outcome and absence of posted result tables when reviewed.

    What it does not support

    Registration is not peer review, a regulatory decision, a published benefit-risk conclusion or a personal treatment plan.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  18. Incyte CorporationManufacturer document · Manufacturer, tier 4Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: Incyte develops povorcitinib, sponsored the studies, analyzed the results and issued the topline update before full peer-reviewed results were available.

    What this source supports

    Supports only Incyte’s report that STOP-V1 and STOP-V2 met the facial endpoint, the stated absolute response percentages, selected topline safety language and planned future vitiligo regulatory filings.

    What it does not support

    The update is not peer-reviewed publication, a regulator decision, proof of availability, direct comparison with another treatment, a complete safety profile or an individual prediction.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  19. DailyMed, U.S. National Library of MedicineRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: The National Library of Medicine hosts DailyMed. The product company submits the label to FDA, so it is authoritative for product labeling but not independent efficacy evidence.

    What this source supports

    Supports the approved indication and product-specific local and systemic corticosteroid warnings for this ointment.

    What it does not support

    It is one current US product label, not a vitiligo indication, a class-wide substitute for every corticosteroid label or independent evidence of vitiligo benefit. Its Dosage and Administration section supports discontinuing once control is achieved and reassessing the diagnosis if no improvement is seen within 2 weeks; its Patient Counseling section notes pediatric safety and effectiveness beyond 3 weeks of use is not known. It is one currently marketed product listed under its generic chemical name, not a brand-name label.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  20. DailyMed, U.S. National Library of MedicineRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: The National Library of Medicine hosts DailyMed. The product company submits the label to FDA, so it is authoritative for product labeling but not independent vitiligo evidence.

    What this source supports

    Supports the 0.05% ointment identity and product-specific potency, local-reaction, skin-atrophy, systemic-absorption, body-area and duration warnings.

    What it does not support

    It does not approve clobetasol for vitiligo, establish vitiligo benefit, or create a regimen for another product. Its Dosage and Administration section supports that treatment should be limited to 2 consecutive weeks and that amounts greater than 50 g per week should not be used, stated specifically to reduce the risk of HPA-axis suppression and local skin effects. It is one currently marketed product listed under its generic chemical name, not a brand-name label.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  21. DailyMed, U.S. National Library of MedicineRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: The National Library of Medicine hosts DailyMed. The product company submits the label to FDA, so it is authoritative for product labeling but not independent vitiligo evidence.

    What this source supports

    Supports the 0.05% cream identity, current tube presentations and product-specific warnings.

    What it does not support

    It does not approve betamethasone dipropionate for vitiligo, establish vitiligo benefit, or show that similarly numbered steroid percentages have the same potency.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  22. DailyMed, U.S. National Library of MedicineRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: The National Library of Medicine hosts DailyMed. The product company submits the label to FDA, so it is authoritative for product labeling but not independent efficacy evidence.

    What this source supports

    It establishes the US atopic-dermatitis indication, boxed warning, local effects, long-term-use precaution, and ultraviolet instructions for this product. Its mechanism-of-action section supports that tacrolimus binds FKBP-12 to block calcineurin phosphatase, preventing the T-cell activation that its boxed warning and local-effect data describe. Its local-adverse-reaction data supports burning in roughly 46-58% and itching in roughly 41-46% of studied patients, most often in the first few days and easing as treatment continues. Its Dosage and Administration section supports applying a thin layer twice daily and re-examining the patient if signs and symptoms do not improve within six weeks.

    What it does not support

    It does not approve tacrolimus for vitiligo or psoriasis, establish efficacy for either, or resolve off-label guideline discussion of supervised combinations. Its dosing and six-week re-examination window are stated for its approved atopic-dermatitis indication, not as a vitiligo-specific schedule.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  23. DailyMed, U.S. National Library of MedicineRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: The National Library of Medicine hosts DailyMed. The product company submits the label to FDA, so it is authoritative for product labeling but not independent efficacy evidence.

    What this source supports

    Supports the US atopic-dermatitis indication, boxed warning, application-site effects, long-term-use precaution and instructions to avoid ultraviolet treatment and minimize natural or artificial sunlight. This label itself is a generic pimecrolimus cream filing (packager Oceanside Pharmaceuticals, a division of Bausch Health US, LLC), not the original brand Elidel label, so it also supports that a generic pimecrolimus cream is currently marketed. Its Dosage and Administration section supports applying a thin layer twice daily and re-examining the patient if signs and symptoms persist beyond six weeks; its boxed warning separately supports that continuous long-term use should be avoided. Its adult 1-year active-comparator adverse-reaction table (328 pimecrolimus-treated subjects) supports application-site burning in about 25.9%, headache in about 25.4%, nasopharyngitis in about 7.6%, and influenza in about 9.8% of that adult trial population.

    What it does not support

    It does not approve pimecrolimus for vitiligo or psoriasis, establish efficacy for either, or resolve off-label guideline discussion of supervised combinations. Its dosing and six-week re-examination window, and its adult adverse-reaction percentages, are stated for its approved atopic-dermatitis indication and trial population, not as a vitiligo-specific schedule or vitiligo-trial safety rate.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  24. DailyMed, U.S. National Library of MedicineRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: The National Library of Medicine hosts DailyMed. The product company submits the label to FDA, so it is authoritative for product labeling but not independent vitiligo evidence.

    What this source supports

    Supports the psoriasis indication, 0.005% cream strength, current tube presentations, local irritation and dermatitis reports, the instruction not to use the cream on the face, contraindications for hypercalcemia or vitamin D toxicity, and calcium-related and ultraviolet precautions. Its Dosage and Administration section supports applying a thin layer twice daily, and that the label’s own safety and efficacy data cover an 8-week psoriasis treatment period. It supports that the label advises patients to avoid excessive natural or artificial sunlight and separately tells physicians they may wish to limit or avoid phototherapy in patients using this product. Its clinical-trial adverse-reaction data support skin irritation in about 10%-15% of patients (the most frequent reaction) and rash, itching, dermatitis, or worsening of psoriasis in about 1%-10%; post-approval reports separately support contact dermatitis, including allergic contact dermatitis.

    What it does not support

    It does not approve calcipotriene for vitiligo, establish vitiligo benefit, support a self-directed combination, or state a vitiligo-specific frequency, duration, or adverse-reaction rate. Its 8-week duration and adverse-reaction percentages are from psoriasis clinical trials, not a vitiligo population.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  25. European Medicines AgencyRegulatory · Regulatory / guideline, tier 1Independent source
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports the European Union marketing authorisation dated 19 April 2023, the marketing authorisation holder Incyte Biosciences Distribution B.V., and the authorised EU indication wording: “Opzelura is indicated for the treatment of non segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.” It also supports that the authorised EU population is narrower than the US one because it requires facial involvement.

    What it does not support

    It does not establish the separate US indication, Great Britain or MHRA status, national pricing, reimbursement or pharmacy availability, comparative superiority, individual suitability, or any use plan.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  26. DailyMed, U.S. National Library of MedicineRegulatory · Regulatory / guideline, tier 1Independence not established
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports the defined US nonsegmental-vitiligo indication, limitations of use, boxed warnings, skin-cancer and ultraviolet precautions, and clinical-study labeling.

    What it does not support

    It also supports the labeled dosing instruction: "Apply a thin layer of OPZELURA topically twice daily to affected areas of up to 10% body surface area." It further supports the labeled re-evaluation point: "If the patient does not find the repigmentation meaningful by 24 weeks, the patient should be re-evaluated by the healthcare provider." It also supports the vitiligo-trial adverse-reaction rates at 1% incidence or greater: application-site acne 6%, application-site itching 5%, a common-cold-type illness (nasopharyngitis) 4%, headache 4%, urinary tract infection 2%, application-site redness (erythema) 2%, and fever (pyrexia) 1%. It does not guarantee benefit, establish suitability beyond the labeled population, authorize adding phototherapy, or state which reaction should prompt a call to the prescriber beyond directing patients to the Medication Guide and their healthcare provider.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  27. Opzelura HCP / Incyte CorporationManufacturer document · Manufacturer, tier 4Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: Incyte manufactures Opzelura and sponsors the page and featured clinician. It is a promotional source and not independent evidence.

    What this source supports

    Supports the manufacturer’s current expectation framing that repigmentation is gradual, varies by person and body area, and may take longer than 24 weeks, plus its dated claim that Opzelura is the only FDA-approved prescription medicine specifically for vitiligo repigmentation. The current FDA label independently controls the indication, trial endpoints, warnings and product facts.

    What it does not support

    It does not independently establish comparative superiority, predict an individual timeline, turn a compensated testimonial into typical experience, or establish that an injected or oral medicine could never receive a future approval.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  28. U.S. Food and Drug AdministrationRegulatory · Regulatory / guideline, tier 1Independent source
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports FDA authorization of this device for repigmentation of stable depigmented vitiligo lesions in a defined adult population and trained professional setting.

    What it does not support

    It does not approve every grafting procedure, define stability for a reader or guarantee color match, durability or satisfaction.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  29. British Journal of Dermatology (Thomas KS, et al.)Randomized trial · Clinical research, tier 2Independent source
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports a group-level benefit for the exact supervised topical-corticosteroid and home handheld-light combination studied in active limited vitiligo, alongside minority success, reactions and limited maintenance after treatment ended.

    What it does not support

    It does not create a general home plan, support other product-device combinations or predict an individual result. The topical-corticosteroid-alone arm used mometasone furoate 0.1% ointment, applied once daily on alternating weeks for up to 9 months. It supports 17% (20/119) reaching participant-reported treatment success at 9 months, and 3% (4/115) reaching the trial’s stricter blinded-assessed ≥75% repigmentation at 9 months. Skin thinning was reported in 2.5% (13/517) of participants across all trial groups, including one on placebo ointment. Over 40% of participants across all groups reported loss of treatment response by 21 months. It supports that participant-reported treatment success at 9 months was lower for patches on the hands and feet than on other body regions, without publishing an exact per-region percentage in its main results tables. The trial randomized 517 adults and children, aged over 5, with nonsegmental vitiligo covering about 10% or less of body surface area and at least one patch active in the prior 12 months, across 16 UK hospitals.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  30. New England Journal of Medicine (Rosmarin D, et al.)Randomized trial · Clinical research, tier 2Independence not established
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports greater prespecified facial and whole-body repigmentation outcomes with ruxolitinib cream than vehicle in the studied nonsegmental-vitiligo population.

    What it does not support

    The trials were funded by Incyte and do not guarantee individual benefit, establish broad comparative superiority or answer every long-term and outside-population question.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  31. ClinicalTrials.gov, U.S. National Library of MedicineTrial registry · Supporting research, tier 3Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: Incyte Corporation sponsored the trial and supplies the posted result tables. ClinicalTrials.gov and the National Library of Medicine host the record; hosting it does not make the trial independent.

    What this source supports

    Supports the whole-body Week 24 result that the current US label does not tabulate: 20.6% of TRuE-V1 participants against 5.1% on vehicle cream reached at least 50% improvement in the total body Vitiligo Area Scoring Index. At the three-quarter bar the figures are 4.1% against 1.8%. The table counts all 330 randomized participants. Its facial figures are 29.8% against 7.4%, which is what the trials own report in the New England Journal of Medicine prints.

    What it does not support

    It is the sponsor posting its own result tables, not a peer-reviewed analysis or an independent audit. Missing scores were filled in by statistical imputation rather than measured. Everyone enrolled had vitiligo covering 10% or less of their body surface, so a whole-body percentage here describes that group and not a person with widespread patches, and it predicts no individual result.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  32. ClinicalTrials.gov, U.S. National Library of MedicineTrial registry · Supporting research, tier 3Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: Incyte Corporation sponsored the trial and supplies the posted result tables. ClinicalTrials.gov and the National Library of Medicine host the record; hosting it does not make the trial independent.

    What this source supports

    Supports the whole-body Week 24 result that the current US label does not tabulate: 23.9% of TRuE-V2 participants against 6.8% on vehicle cream reached at least 50% improvement in the total body Vitiligo Area Scoring Index. At the three-quarter bar the figures are 8.0% against 1.8%. It also records why this trial reads differently in different documents. Every table here leaves out one study site for serious protocol noncompliance, so 222 and 109 people are counted of the 344 enrolled. On that population the facial figures are 30.9% against 11.4%, which are the New England Journal of Medicine numbers rather than the label ones.

    What it does not support

    It is the sponsor posting its own result tables, not a peer-reviewed analysis or an independent audit. Missing scores were filled in by statistical imputation rather than measured. Everyone enrolled had vitiligo covering 10% or less of their body surface, so a whole-body percentage here describes that group and not a person with widespread patches, and it predicts no individual result.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  33. Journal of Investigative Dermatology (Pandya AG, et al.)Observational study · Supporting research, tier 3Independence not established
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports exploratory, supervised combination evidence from a study that enrolled 55 people with nonsegmental vitiligo; 35 early nonresponders added narrowband ultraviolet B and 26 were evaluable later.

    What it does not support

    The study includes Incyte authors and lacks a randomized combination comparator. It does not establish combination superiority, a general sequence, independent comparative benefit or a self-directed plan.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  34. JAMA Dermatology (Lee JH, et al.)Systematic review · Clinical research, tier 2Independent source
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports pooled group-level repigmentation outcomes for topical calcineurin inhibitors alone and with phototherapy, including variation by body area.

    What it does not support

    Considerable study heterogeneity limits product-specific and individual inference, and the review does not override current product labels or prove one medicine superior. Supports the exact pooled figures: 55.0% (560 patients, 21 studies) reached at least a mild (>=25%) response, 38.5% (619 patients, 23 studies) reached a moderate (>=50%) response, and 18.1% (520 patients, 19 studies) reached a marked (>=75%) response using a calcineurin inhibitor alone, versus 47.5% marked response when combined with phototherapy. Supports a median treatment duration of 3 months (range 2-7 months) across the pooled studies.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  35. JAMA Dermatology (Bae JM, et al.)Systematic review · Clinical research, tier 2Independent source
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports the separate pooled repigmentation rates and participant counts the review reports for narrowband UVB and PUVA at 3, 6 and 12 months, and the narrowband UVB rates pooled by body region after at least 6 months. Each pooled figure rests on the subset of studies that reported that measure at that time, not on the full review. It also supports plainly labelled arithmetic complements of those reported rates.

    What it does not support

    The pooled arms are single-group, so they describe what happened to those groups, not what the light caused. The review planned an intention-to-treat count and kept people who stopped early where it could; otherwise it used the group described at the final assessment, so no pooled figure is guaranteed to cover every enrolled participant. It does not report how many people worsened during treatment, does not predict an individual course, and sets no device, schedule or dose.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  36. JAMA Dermatology (Ju HJ, et al.)Systematic review · Clinical research, tier 2Independence not established
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports that multiple surgical techniques have been studied for selected stable vitiligo and that reported response and adverse effects vary by method and study.

    What it does not support

    Much of the evidence is nonrandomized and an author reported industry relationships; the review does not determine stability, eligibility, color match, durability or individual outcome.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  37. eClinicalMedicine (Passeron T, et al.)Randomized trial · Clinical research, tier 2Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: AbbVie funded the study, and multiple authors were AbbVie employees. The peer-reviewed design and results remain sponsor-linked evidence.

    What this source supports

    Supports the reported randomized phase 2 design, 185-adult study population, facial and total-body outcomes, continued improvement during follow-up, and reported adverse events.

    What it does not support

    It does not establish approval, comparative superiority, reliable outcomes for individual hands or feet, long-term safety, or an individual result.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  38. ClinicalTrials.gov, U.S. National Library of MedicineTrial registry · Supporting research, tier 3Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: ClinicalTrials.gov hosts the record, while AbbVie sponsors the studies and supplies the registered information.

    What this source supports

    Supports the replicate randomized phase 3 protocol, enrolled population, study status, and the registered exploratory narrowband-UVB substudy. The registry did not post phase 3 result tables or a combination result when reviewed.

    What it does not support

    Registration is not peer review, regulatory approval, proof that adding phototherapy helps, or a personal treatment plan.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  39. AbbVieManufacturer document · Manufacturer, tier 4Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: AbbVie manufactures Rinvoq, sponsored the studies, analyzed the results, and issued the release before full peer-reviewed publication.

    What this source supports

    Supports only AbbVie’s reported Viti-Up enrollment, facial and total-body response percentages, selected adverse-event summary, and sponsor interpretation.

    What it does not support

    The release is not peer-reviewed trial publication, direct comparison with another treatment, body-site-specific proof for hands or feet, long-term safety evidence, or an individual prediction.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  40. electronic Medicines Compendium / AbbVie LtdManufacturer document · Manufacturer, tier 4Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: The electronic Medicines Compendium hosts company-supplied UK product information. It is useful for current listed indications but is not independent clinical evidence.

    What this source supports

    Supports that the UK product information reviewed did not list a vitiligo indication.

    What it does not support

    It does not prove that no later MHRA decision exists or establish status outside the UK.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  41. U.S. Food and Drug AdministrationRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: The product company authored the prescribing information hosted by FDA. It is authoritative for the historical label but not independent clinical evidence.

    What this source supports

    Supports the historical US indication for final depigmentation in extensive disseminated idiopathic vitiligo, the purpose and mechanism limits, permanence and distant-depigmentation warnings, listed reactions, contraindication boundary, and long-term unknowns. Re-read in full on 2026-08-21 for what it states about sun, which is in three places. Under Precautions, General, it states that following therapy with the cream the skin will be sensitive for the rest of the patient’s life, and that the person must use sunscreens during exposure to the sun. Under Clinical Pharmacology it states that exposure to sunlight reduces the depigmenting effect of the drug. The same section states that the histology of the skin after depigmentation with topical monobenzone is the same as that seen in vitiligo, the epidermis being normal except for the absence of identifiable melanocytes. Under Dosage and Administration it states that prolonged exposure to sunlight should be avoided during treatment, or that a sunscreen should be used. Under Carcinogenesis, mutagenesis, impairment of fertility it states that no long term studies have been performed to evaluate carcinogenic potential.

    What it does not support

    The archived label does not establish current commercial availability, approval of a compounded preparation, predictable uniform results, suitability, a personal plan, or current status outside the US. Its sun statements are the label instructing a patient under a prescriber; SteadySkin reports them as the label’s wording and issues none of them as advice. It sets no sun protection factor, no interval and no exposure limit, and it measures nothing about how depigmented skin behaves in sunlight beyond the sensitivity statement itself. Because it performed no long term carcinogenicity study, it establishes nothing about skin cancer risk after depigmentation in either direction. The document carries a printed revision of August 2000 and an FDA banner stating it may not be the latest approved label, so it is used only for what it plainly states and never as current guidance.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  42. U.S. Food and Drug AdministrationRegulatory · Regulatory / guideline, tier 1Independent source
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports the distinction between Benoquin’s retained historical approval record and the FDA-reviewed statement that the branded product was no longer manufactured or distributed and its structured label had been delisted.

    What it does not support

    It does not establish present inventory, lawful access for one person, the quality of any compounded preparation, or status outside the US.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  43. U.S. Food and Drug AdministrationRegulatory · Regulatory / guideline, tier 1Independent source
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports the general US boundary that compounded drugs are not FDA-approved and FDA does not verify their safety, effectiveness, or quality before marketing.

    What it does not support

    It does not determine whether compounding is appropriate or lawful in an individual case, assess a particular pharmacy, or establish the quality of a particular monobenzone preparation.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  44. British Journal of Dermatology (Mosher DB, Parrish JA, Fitzpatrick TB)Observational study · Supporting research, tier 3Independent source
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports only the reported outcomes, complications, and satisfaction observations in a retrospective series of 18 people using monobenzyl ether of hydroquinone for final depigmentation.

    What it does not support

    The very small uncontrolled series cannot establish a predictable success rate, body-site response, long-term safety, comparison with other paths, or an individual outcome.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  45. U.S. Food and Drug AdministrationRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: FDA authored the regulatory summary, while the pivotal evidence was manufacturer-sponsored and submitted. The decision record is authoritative but the underlying clinical evidence is not independent.

    What this source supports

    Supports the FDA-reviewed device description, pivotal within-person randomized study of 25 adults, population and body sites, absolute repigmentation outcomes, adverse events, contraindications, limitations, and the fact that the studied RECELL area also received ablative-laser preparation and later narrowband UVB.

    What it does not support

    The study cannot isolate the cell suspension from laser preparation, establish use without later phototherapy, predict an individual result, prove complete repigmentation, or establish current authorization outside the US.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  46. U.S. Food and Drug AdministrationRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: FDA hosts the approved instructions supplied by the device manufacturer. They control product use but are not independent comparative evidence.

    What this source supports

    Supports the trained-professional setting, donor-skin processing, ablative-laser surface preparation, contraindications, warnings, aftercare responsibilities, and body-site and population limitations in the approved US instructions.

    What it does not support

    The instructions do not select a patient, center, lesion, laser, aftercare plan, or predict response, color match, recovery, or coverage.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  47. Journal of the European Academy of Dermatology and VenereologyGuideline · Regulatory / guideline, tier 1Relevant relationship disclosed
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    Why the independence label says this: The journal is the publisher. This label refers to extensive author relationships disclosed for the recommendation, not to the journal itself.

    What this source supports

    It supports current expert-consensus terminology, clinical assessment, disease-activity evaluation, treatment-goal discussion, and shared decision-making. Its modified assessment check list names where the patches are as a disease feature, and gives genital involvement as its own example. It records white hairs as an item of its own, apart from what the vitiligo has done in the past six months. Its classification table keeps mucosal vitiligo as a subtype, both across more than one site and at one site alone. It supports planning care around what is there to work with, and its example is hair that still has its color. It names stable vitiligo and active vitiligo as two different states that change the care plan. Its shared-decision steps ask what the patient wants from care. At the time it was written, one cream form of a newer drug type had just been approved. Pill forms of that same drug type were still being studied.

    What it does not support

    It is not independent comparative proof. It cannot diagnose a reader from a description or photograph. It gives no figure for genital involvement, and it does not name lichen sclerosus. It does not set out the Vitiligo European Task Force grading scale. It puts no figure on white hairs and predicts nothing for one person.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  48. British Journal of Dermatology (Eleftheriadou V, et al.)Guideline · Regulatory / guideline, tier 1Independent source
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports the clinical history and assessment domains, evaluation of associated autoimmune conditions, its recommendation for thyroid function and antithyroid antibody screening, current classification context, treatment-option map, psychosocial assessment, medical photography and the limits of pediatric evidence. Its classification table defines mucosal vitiligo as the oral or genital mucosae. One mucosal site alone is filed as undetermined or unclassified. Its differential diagnosis table lists genital or extragenital lichen sclerosus among the conditions that can be mistaken for vitiligo. That table also lists eczema, psoriasis, lichen planus, pityriasis alba and piebaldism. It calls autoimmunity a contributor to the pathogenesis of vitiligo. It reports an earlier review finding a possible negative impact on intimacy and sexual functioning. It tells clinicians to discuss the psychosocial impact of living with the condition. R28 offers a skin camouflage visit to people who want one. R10 to R14 name potent or very potent topical steroids as the first choice, with a topical calcineurin-inhibitor cream as an option for the face. These are different creams with different proof behind them. R20 names narrowband UVB as the first light option. It says the skin often does better on the face and trunk than on hands and feet. It says there is not enough proof to use any one current pill alone for vitiligo that is not changing. R25 and Table 2 keep cell grafting for vitiligo that is not changing and did not respond to other care. They also say a doctor cannot always tell if the vitiligo has truly stopped changing.

    What it does not support

    It was designed for UK care and reviewed literature through May 2019; it does not establish a universal testing plan, prescribe an individual plan, or establish current US labeling or coverage. Its differential diagnosis table is a list, not a method a reader can apply to their own skin. It does not say how to tell any two of those conditions apart. It gives no figure for how often vitiligo affects genital skin.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  49. American Academy of DermatologyPatient education · Patient education, tier 5Independence not established
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    Supports current US patient-language context that lighter patches have multiple causes, dermatologists diagnose vitiligo from history and examination, treatment is optional and several broad management paths exist.

    What it does not support

    The page acknowledges support from Incyte Dermatology, so it does not independently establish drug efficacy or comparative superiority.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

  50. British Journal of Dermatology (Goulden V, et al.)Guideline · Regulatory / guideline, tier 1Independent source
    Published
    SteadySkin last checked
    What this source can and cannot tell you

    What this source supports

    It supports that traditional NB-UVB fluorescent lamps emit a narrow UVB band peaking around 311 nanometres. It backs wearing UV-protective goggles and keeping UV scatter off people nearby. It records the consent form naming goggles and the same clothing at each session. It also covers clinical uses, how it compares with other light treatments, safety limits including sunburn-type reactions, and the added safeguards home phototherapy needs.

    What it does not support

    It does not provide a personal treatment plan, approve a particular home setup, or replace the instructions for your own device. SteadySkin never reproduces its treatment schedules.

    Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.

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Evidence details

Review what this source supports, what it cannot establish, and any relevant relationships.