Does “FDA approved” mean an option is best?
No. Identify whether the option is approved, off-label, experimental, procedural, cosmetic, supportive care, or no active treatment. Its status and evidence strength are different. Approval does not guarantee a result. Off-label use is not automatically unsupported. Evidence Evidence Evidence Evidence Evidence Evidence Evidence Evidence Evidence Evidence Evidence
What is known
- Sources cited, not yet graded
I checked the labels and approval records behind this row. Opzelura (ruxolitinib cream) has a defined US vitiligo indication. It also has its own EU approval, which asks for face patches. Rinvoq has a defined EU authorization for vitiligo, but not a current US or UK indication. RECELL has a defined US device indication for selected stable adult lesions. Benoquin has a historical approval record. Current branded-product access and compounded monobenzone status are separate facts.
What is uncertain
- Depends on you
Status varies by country and can change. A broad category cannot replace the current label and approval status for the exact medicine or product you are considering.
Questions for your clinician
Is this use approved, off-label, or investigational here?
Saving keeps this on your device and needs JavaScript, which is off in this browser.What independent evidence supports discussing it for me beyond that status?
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Which study details actually matter to me?
For each option, ask these questions: Evidence Evidence Evidence Evidence Evidence
- Who was in the study?
- Which body areas and vitiligo patterns were included?
- What was the treatment compared with?
- What counted as success?
- How long were people followed?
- How much did results vary?
- What could the study not answer?
What is known
- Sources cited, not yet graded
Vitiligo studies use different outcomes, comparators, populations, follow-up, and body areas. Ruxolitinib cream, Rinvoq, a topical-plus-light plan, and the RECELL package are not interchangeable. Their results cannot become one “success rate.”
What is uncertain
- Depends on you
Comparisons across separate trials are indirect unless one study tested the options against each other. Evidence may be incomplete for durability, different skin tones, age groups, body areas, or the outcome that matters most to you.
Questions for your clinician
Which result best reflects my goal?
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What should I compare besides possible benefit?
People I have heard from ask about side effects as early as they ask about results. Compare material risks, reasons an option may not fit, follow-up, clinic and home burden, reversibility, access, and cost uncertainty beside possible benefit. Also include what waiting, camouflage, supportive care, or declining the option would mean for your goal. Evidence Evidence Evidence Evidence Evidence Evidence Evidence Evidence Evidence
What is known
- Sources cited, not yet graded
Product labels, guidelines, and trials contribute different parts of the picture. Time, travel, cost, and access are valid parts of your decision, but they do not prove one treatment is medically better.
What is uncertain
- Depends on you
Research may underdescribe the day-to-day burden or may not reflect your health system. Coverage and price can change, and a warning list cannot calculate your personal risk.
Questions for your clinician
Which differences in risk, daily burden, and access matter most for me?
Saving keeps this on your device and needs JavaScript, which is off in this browser.What support could still address my goal without treatment?
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What if I cannot find an answer for one of the options?
Treat the answer as missing - not as zero risk, no benefit, or a guessed value. “Not established,” “not found in the reviewed source,” and “not applicable” mean different things. The gap can become a question for your clinician instead of a false sense of certainty. Evidence Evidence
What is known
- Sources cited, not yet graded
Evidence gaps are common for direct comparisons, long-term outcomes, particular body areas, children, different skin tones, and day-to-day burden. Naming the gap protects you from the false impression that someone has already answered every important question.
What is uncertain
- Depends on you
“Not established” may mean no relevant research was found, the available research is inadequate, or the current review did not resolve the question. Check which meaning applies and when the information was reviewed.
Questions for your clinician
Is this unstudied, uncertain, or not yet reviewed?
Saving keeps this on your device and needs JavaScript, which is off in this browser.Does this gap justify another source or opinion?
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Evidence and update context
This optional layer shows the evidence boundary I reviewed as of 2026-09-19.
- What this evidence supports
- I checked the labels and approval records behind this row. Opzelura (ruxolitinib cream) has a defined US vitiligo indication. It also has its own EU approval, which asks for face patches. Rinvoq has a defined EU authorization for vitiligo, but not a current US or UK indication. RECELL has a defined US device indication for selected stable adult lesions. Benoquin has a historical approval record. Current branded-product access and compounded monobenzone status are separate facts.
- What it does not establish
- Status varies by country and can change. A broad category cannot replace the current label and approval status for the exact medicine or product you are considering.
Pending clinical review
This statement has a dated source and is waiting for a clinician's sign-off.
Pending clinical review
This statement has a dated source and is waiting for a clinician's sign-off.
Evidence behind this page
Sources
Each evidence badge opens the source and its limits. The full list stays available here.
- 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.
Protopic (tacrolimus) ointment: US prescribing information and Medication Guide (opens in a new tab)
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.