What may be at the pharmacy
Pharmacies dispense the branded Opzelura product. The dated cost snapshot below records the current generic-availability check.
US cost and coverage snapshot · checked August 16, 2026
No FDA-approved generic was found in the current record.
Documented manufacturer list cost (WAC) checked August 16, 2026: $2,094 for one tube. WAC is not the amount everyone pays; the pharmacy and insurer must quote the actual amount.
Eligible people with commercial insurance may pay as little as $0 per tube under the current manufacturer offer, with maximums and exclusions. Government-funded coverage and cash-pay patients cannot use that card. A separate assistance program may help some uninsured, underinsured, or Medicare Part D patients.
- Opzelura (opens in a new tab): Current cost context and savings-program route · manufacturer · moderate confidence · checked August 16, 2026
- IncyteCARES (opens in a new tab): Current patient-assistance paths and eligibility limits · manufacturer · moderate confidence · checked August 16, 2026
- US Food and Drug Administration (opens in a new tab): Current FDA product record shows no approved generic · primary · high confidence · checked August 16, 2026
Patient-community context · anecdotal
What some people described online
The two linked posts described questions about timing, slow or uneven visible change, and the burden of regular application. They do not show what experience is typical or what caused a change.
These are self-selected posts, not clinical evidence. Diagnoses, products, other treatments, and adherence cannot be verified. There is no denominator. The posts cannot establish efficacy, frequency, typical experience, safety, what caused an experience, or support a treatment recommendation.
These posts are registered as Tier 6 lived experience for question discovery. They are not citations supporting a treatment claim. Relationship status: not established.
- Community discussion · timing · August 2026Pseudonymous poster in an online support group · Lived experience - not evidence · published August 5, 2026 · checked August 16, 2026The author is pseudonymous. Their identity, product use, other treatments, adherence, and financial or organizational relationships cannot be verified.
- Community discussion · adherence and slow response · September 2025Pseudonymous poster in an online support group · Lived experience - not evidence · published September 18, 2025 · checked August 16, 2026The author is pseudonymous. Their identity, product use, other treatments, adherence, and financial or organizational relationships cannot be verified.
Compare this topical with another option
Does approval mean Opzelura fits my vitiligo?
Not automatically. Each country or region sets its own rule. In the US, ruxolitinib cream is approved for nonsegmental vitiligo in adults and children ages 12 and older. In the EU, it is approved for nonsegmental vitiligo that affects the face, in the same age group. Your own pattern, age, extent, and other limits must still match the rule where you are treated. Think of the enzyme ruxolitinib blocks (JAK) as a relay switch immune cells use to signal an attack on pigment cells. Blocking that switch does not repair a patch directly; it aims to quiet the signal telling the immune system to keep attacking it. Evidence Evidence
Why this matters
- Sources cited, not yet graded
Ruxolitinib is a Janus kinase inhibitor, and Opzelura is the brand name. I read the FDA-approved prescribing information. It defines who was included in the US indication, limitations of use, warnings, and other information your prescriber must apply. The EU has its own record, dated 19 April 2023. It asks for face patches, so it covers a smaller group. I did not verify a Great Britain status in the records I read.
Considerations
- Depends on you
A vitiligo diagnosis alone does not show that you fit the label or that the medicine is appropriate for you. Your vitiligo pattern and extent, health history, other medicines, pregnancy considerations, and any current label changes need review.
Questions for your clinician or insurer
Does my vitiligo fit the rule where I am treated?
Saving keeps this on your device and needs JavaScript, which is off in this browser.Which label limits could make it a poor fit?
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How likely is it to help my patches?
People I have heard from ask whether it works, and then where it works. It depends a great deal on where your patches are, and the trials measured the face and the whole body separately. At Week 24, on the face, 29.9% of people using Opzelura reached at least 75% improvement, against 7.5% and 12.9% on the inactive cream. Across the whole body, at the halfway bar, it was 20.6% and 23.9%, against 5.1% and 6.8%. The same figures read the other way round say this: Evidence Evidence Evidence Evidence Evidence Evidence
- On the face, about 7 in 10 did not reach the three-quarter bar. 70.1% in each trial.
- Across the whole body, 79.4% and 76.1% did not reach even the halfway bar.
- At the three-quarter bar across the whole body, 95.9% and 92.0% did not reach it.
- No trial can tell you what your own patches will do.
Why this matters
- Sources cited, not yet graded
The trials enrolled adolescents and adults with nonsegmental vitiligo under defined eligibility criteria and used standardized measures of repigmentation. Their randomized, controlled design supports a treatment effect in the population studied. The US label tabulates facial results only. I took the whole-body figures from the result tables the sponsor posted to the ClinicalTrials.gov registry. Everyone randomized stayed in the totals, and scores that were missing at Week 24 were estimated statistically rather than measured. One eligibility rule shapes every whole-body number here: nobody enrolled had vitiligo covering more than 10% of their body surface. Two later reports followed the same people further. People who had reached near-complete facial repigmentation at Week 52 were randomly assigned either to continue the cream or to move to the inactive one. At Week 104, 38 of 55 who continued and 22 of 56 who moved still held at least 75% facial improvement. A pooled look at body areas found that at Week 52, 38.2% reached at least 50% improvement on the hands and 29.3% on the feet.
Considerations
- Depends on you
The trials do not answer every question about people outside their rules. The longer follow-up enrolled only people who had already responded well. It was not designed to prove that one group did better than the other. Personal satisfaction remains uncertain. These percentages also cannot be set beside the ones I give for other treatments. Those come from different trials, at different weeks, on different measures. Only a head-to-head study could rank two treatments against each other. Incyte funded all of this research, which matters when judging how independent it is.
Questions for your clinician or insurer
What improvement would count as meaningful?
Saving keeps this on your device and needs JavaScript, which is off in this browser.What do we know about how long it may last?
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Face
About 29.9% of people reached at least three-quarter improvement by week 24.
Whole body
About 20.6% to 23.9% of people reached at least half improvement by week 24.
Hands
In a separate week-52 look, about 38.2% reached at least half improvement.
Feet
In the same week-52 look, about 29.3% reached at least half improvement.
Face and whole-body figures are from the two randomized trials cited above, compared with an inactive cream at week 24. Hands and feet figures are from a separate pooled analysis at week 52, without an inactive-cream comparison, and cannot predict your own patch.
How often do you use it, and how long before you know if it is working?
The label directs applying a thin layer twice daily to affected areas covering up to 10% of your body surface. If repigmentation does not feel meaningful by 24 weeks, the label’s own instruction is to be re-evaluated by your prescriber. That is the same Week 24 point the trial percentages above are measured at. Evidence
Why this matters
- Sources cited, not yet graded
I checked the current US label. It states this dosing frequency, the 10%-body-surface application limit, and the 24-week re-evaluation point directly.
Considerations
- Depends on you
The label sets a general re-evaluation point, not a personal timeline. How your prescriber interprets a partial or absent response before or after 24 weeks is a clinical judgment call, not something the label pre-decides for you.
Questions for your clinician or insurer
Should we reassess before 24 weeks if I see nothing at all?
Saving keeps this on your device and needs JavaScript, which is off in this browser.What would count as enough improvement to keep going?
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What should I understand about the boxed warnings?
The US label carries the FDA’s strongest safety alert, called a “boxed warning.” It covers serious risks reported with this drug class, called JAK inhibitors. Separately, in the vitiligo trials themselves, the most common reactions were milder and far more frequent than the boxed-warning risks. They were application-site acne (6%), application-site itching (5%), a common-cold-type illness (4%), headache (4%), urinary tract infection (2%), application-site redness (2%), and fever (1%). Evidence
- Serious infections
- Cancer
- Major heart problems
- Blood clots
- Death
Why this matters
- Sources cited, not yet graded
Some warning evidence comes from a different JAK inhibitor taken by mouth in another group. The label also calls for checks for non-melanoma skin cancer and limits sunlight and ultraviolet exposure. It advises against use with certain other immune-system treatments. The vitiligo-trial reaction rates above are the ones I read in the label’s own adverse-reaction table.
Considerations
- Depends on you
The label does not predict your chance of harm. It also does not spell out which specific symptom should make you call your prescriber right away. Instead, it directs patients to the Medication Guide and their healthcare provider generally. Your history of infections, cardiovascular or clotting problems, cancer, current skin findings, and other medicines can change how the warnings apply.
Questions for your clinician or insurer
Which boxed warnings and precautions matter most given my health history?
Saving keeps this on your device and needs JavaScript, which is off in this browser.Which of the common reactions should I just watch, and which should prompt a call?
Saving keeps this on your device and needs JavaScript, which is off in this browser.What monitoring would I need?
Saving keeps this on your device and needs JavaScript, which is off in this browser.I take ___. Does this label warn against combining it with that?
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Four more answers: combining with phototherapy, insurance and cost, what other patients say, and what to track
What if phototherapy is suggested too?
Ask the prescriber and light-therapy team to coordinate before you proceed. The current US ruxolitinib label includes ultraviolet-exposure precautions and does not establish when or how to add phototherapy. Do not create a combined plan yourself. Evidence
Why this matters
- Sources cited, not yet graded
The label tells patients to limit sunlight and ultraviolet exposure and includes other medicine-specific warnings that the treating team must interpret.
Considerations
- Depends on you
The label does not establish the benefit, safety, sequence, device, or monitoring for a combined plan. Any separate combination evidence needs its own qualified review.
Questions for your clinician or insurer
Is this established care or based on early research?
Saving keeps this on your device and needs JavaScript, which is off in this browser.Who is coordinating the ultraviolet precautions?
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What if insurance will not cover it or the cost is too high?
Coverage, insurer approval, pharmacy access, and your cost can decide whether the medicine is workable. They do not decide whether it is medically right for you. An insurer’s decision or eligibility for a maker program does not show whether the medicine will help you. Evidence
Why this matters
- Sources cited, not yet graded
The medicine is prescription-only, and payer requirements differ by plan and can change. Ask the care team to separate the medical reason from the insurer’s rules. This keeps a coverage problem from being mistaken for a medical verdict.
Considerations
- Depends on you
Verify current benefits and authorization with your insurer and pharmacy. Program terms, eligibility, formularies, and pharmacy networks can change, and manufacturer assistance information is not independent treatment evidence.
Questions for your clinician or insurer
What documentation does my plan currently require?
Saving keeps this on your device and needs JavaScript, which is off in this browser.What alternatives fit if cost or access blocks this?
Saving keeps this on your device and needs JavaScript, which is off in this browser.Who can help with a denial?
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What do other people say about using it?
No reader has shared a first-hand account of using Opzelura for vitiligo yet. Until someone does, here is what the label and the trials say about living with it. Evidence
Why this matters
- Sources cited, not yet graded
The most common vitiligo-trial reactions were mild: application-site acne, itching, a common-cold-type illness, headache. The label frames the boxed-warning risks as rare, not routine.
Considerations
- Depends on you
No one has shared yet what the twice-daily routine feels like day to day, or how visible early change was before the 24-week check-in.
Questions for your clinician or insurer
What have your other patients told you about using this day to day?
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What is worth tracking while you use it?
Keep a simple, dated record: when you started, how often you actually applied it, and a same-conditions photo (same light, distance, and angle) each time. Note the treated body area specifically, since the trials found repigmentation varies a great deal by where a patch sits. That record gives you and your prescriber something concrete to compare at the label’s own 24-week re-evaluation point, rather than relying on memory. Evidence
Why this matters
- Sources cited, not yet graded
A dated, comparable, area-labeled record is what lets the 24-week re-evaluation point actually answer whether the medicine is working for that patch. It beats relying on whether it just feels different.
Considerations
- Depends on you
A photo log does not replace a clinical exam and cannot by itself tell you whether a rarer boxed-warning effect has started.
Questions for your clinician or insurer
What should I photograph or note between now and my next visit?
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Questions that can change the next decision
For your prescriberDoes my diagnosis and health history fit the current US label, and which warnings matter most for me?
Saving keeps this on your device and needs JavaScript, which is off in this browser.For your prescriberWhat result would count as meaningful, and when would we review whether the burden and risks remain worthwhile?
Saving keeps this on your device and needs JavaScript, which is off in this browser.For your insurer or pharmacy benefit managerWhat current coverage rule, documentation, network pharmacy, and review route apply to this exact prescription?
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Evidence detail: current label and pivotal trials
Open this layer when you want the study and regulatory context behind the patient summary.
- Current US status
- The current US label includes topical treatment of nonsegmental vitiligo in adults and children 12 years and older. Opzelura is supplied as ruxolitinib cream 1.5% in 60 g and 100 g tubes, with additional indication limits and precautions for a prescriber to apply.
- Current EU status, checked 17 August 2026
- The EU record shows its own approval, dated 19 April 2023. The holder is Incyte Biosciences Distribution B.V. It covers nonsegmental vitiligo that affects the face, in adults and children from age 12. The US wording does not ask for face patches, so the EU group is smaller. I did not verify a Great Britain status in the records I read.
- What the pivotal evidence measured
- Two randomized, vehicle-controlled phase 3 trials enrolled 674 adolescents and adults with defined nonsegmental vitiligo. The facial figures I give here are the ones printed in the current US label. They are 29.9% against 7.5% in one trial and 29.9% against 12.9% in the other, for at least 75% improvement in facial vitiligo at Week 24. The trials’ own report in the New England Journal of Medicine prints 29.8% against 7.4% and 30.9% against 11.4% for the same measure. The registry record for the second trial accounts for most of that gap. Its tables leave out one study site for serious protocol noncompliance. So they count 222 and 109 people where the label counts 229 and 115. On that smaller group the figure is 30.9% against 11.4%. The first trial still differs by a tenth of a point either way, on the same 221 and 109 people, and I have not established what accounts for that.
- What the trials found across the whole body
- The label tabulates facial results only. The sponsor’s posted registry tables also report the total body Vitiligo Area Scoring Index at Week 24. At the halfway bar, 20.6% and 23.9% of people using ruxolitinib cream reached at least 50% improvement, against 5.1% and 6.8% on vehicle cream. At the three-quarter bar the figures fall to 4.1% and 8.0%, against 1.8% in both trials. Nobody enrolled had vitiligo covering more than 10% of their body surface, so these whole-body percentages describe that group and not someone with widespread patches.
- What happened after Week 52
- A separate extension study followed people who had reached near-complete facial repigmentation at Week 52. They were randomly assigned either to continue ruxolitinib cream or to move to the inactive cream for another year. At Week 104, 38 of 55 who continued and 22 of 56 who moved still held at least 75% facial improvement. Everyone in it had already responded, more people left the withdrawal group, and it set no sample size for a powered comparison.
- What the trials showed by body area
- A pooled analysis of the same two trials reported repigmentation by body region. At Week 52, among people who applied ruxolitinib cream only, 68.1% reached at least 50% improvement on the head and neck excluding the face, 38.2% on the hands and 29.3% on the feet. It was reported as a letter and was not designed to compare body areas.
- What it did not establish
- The trials do not predict an individual result, establish superiority over every alternative, or answer every question for people outside the study criteria. The FDA label is authoritative for approved study labeling, but it is not independent efficacy evidence.
- Safety context
- The most common reactions in the vitiligo trials were application-site acne and itching, common-cold-type symptoms, headache, urinary tract infection, application-site redness, and fever. The current label also carries boxed warnings for serious infections, mortality, malignancy, major cardiovascular events, and thrombosis, plus product-specific precautions. A prescriber must interpret these for the individual.
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.
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.
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.
Applicability check
Who was studied?
These fields show what the cited evidence reports about the people and body sites behind outcome or safety claims. “Not reported” means the reviewed source omitted the field; “Pending exact source review” means SteadySkin has not made that determination yet.
People I have heard from ask whether it works, and then where it works. It depends a great deal on where your patches are, and the trials measured the face and the whole body separately. At Week 24, on the face, 29.9% of people using Opzelura reached at least 75% improvement, against 7.5% and 12.9% on the inactive cream. Across the whole body, at the halfway bar, it was 20.6% and 23.9%, against 5.1% and 6.8%. The same figures read the other way round say this: On the face, about 7 in 10 did not reach the three-quarter bar. 70.1% in each trial. Across the whole body, 79.4% and 76.1% did not reach even the halfway bar. At the three-quarter bar across the whole body, 95.9% and 92.0% did not reach it. No trial can tell you what your own patches will do.
- Age range
- Pending exact source review
- Condition subtype
- Pending exact source review
- Severity or extent
- Pending exact source review
- Sample size
- Pending exact source review
- Geography and care setting
- Pending exact source review
- Skin tone or phototype
- Pending exact source review
- Race
- Pending exact source review
- Ethnicity
- Pending exact source review
- Body sites
- Pending exact source review
What that means for this page: This is explicitly gated as a group-level outcome claim, but exact population extraction is still pending. It cannot publish or support an individual prediction until that review is complete.
The US label carries the FDA’s strongest safety alert, called a “boxed warning.” It covers serious risks reported with this drug class, called JAK inhibitors. Separately, in the vitiligo trials themselves, the most common reactions were milder and far more frequent than the boxed-warning risks. They were application-site acne (6%), application-site itching (5%), a common-cold-type illness (4%), headache (4%), urinary tract infection (2%), application-site redness (2%), and fever (1%). Serious infections Cancer Major heart problems Blood clots Death
- Age range
- Pending exact source review
- Condition subtype
- Pending exact source review
- Severity or extent
- Pending exact source review
- Sample size
- Pending exact source review
- Geography and care setting
- Pending exact source review
- Skin tone or phototype
- Pending exact source review
- Race
- Pending exact source review
- Ethnicity
- Pending exact source review
- Body sites
- Pending exact source review
What that means for this page: This is explicitly gated as a safety claim, but exact population extraction is still pending. It cannot publish or support an estimate of individual risk until that review is complete.
In each of two controlled Opzelura trials, 29.9% of participants reached at least 75% improvement in facial vitiligo at Week 24, compared with 7.5% and 12.9% using vehicle cream. Across the whole body, 20.6% and 23.9% reached at least 50% improvement, compared with 5.1% and 6.8%.
- Age range
- Age 12 years and older; 11% were age 12–17 and 7% were age 65 or older.
- Condition subtype
- Nonsegmental vitiligo.
- Severity or extent
- At least 0.5% facial and at least 3% non-facial body-surface involvement, with total vitiligo involvement up to 10%.
- Sample size
- 674 participants across two randomized trials.
- Geography and care setting
- Not reported
- Skin tone or phototype
- Fitzpatrick I 2%, II 30%, III 40%, IV 19%, V 7%, and VI 2%.
- Race
- 82% White, 5% Black, 4% Asian, and 9% other races.
- Ethnicity
- Not reported
- Body sites
- The primary outcome was facial repigmentation; total-body assessment included face, hands, feet, limbs, and trunk.
What that means for this page: These controlled results apply most directly to people resembling the trial population. They do not establish the same response for segmental vitiligo, greater body-surface involvement, younger children, every body site, or an individual patient.
The current Opzelura label lists common vitiligo-trial reactions and carries boxed warnings and other material precautions; some boxed-warning evidence comes from oral JAK-inhibitor studies in a different population.
- Age range
- Age 12 years and older; 11% were age 12–17 and 7% were age 65 or older.
- Condition subtype
- Nonsegmental vitiligo.
- Severity or extent
- At least 0.5% facial and at least 3% non-facial body-surface involvement, with total vitiligo involvement up to 10%.
- Sample size
- 674 participants across two randomized trials.
- Geography and care setting
- Not reported
- Skin tone or phototype
- Fitzpatrick I 2%, II 30%, III 40%, IV 19%, V 7%, and VI 2%.
- Race
- 82% White, 5% Black, 4% Asian, and 9% other races.
- Ethnicity
- Not reported
- Body sites
- The primary outcome was facial repigmentation; total-body assessment included face, hands, feet, limbs, and trunk.
What that means for this page: Common-reaction data came from the vitiligo program, while several serious boxed-warning observations came from oral JAK-inhibitor studies in older rheumatoid-arthritis populations with cardiovascular risk. The label applies those warnings to Opzelura, but the evidence contexts must not be treated as identical or used to calculate personal risk.
Evidence behind this page
Sources
Each evidence badge opens the source and its limits. The full list stays available here.
- 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: The medicine manufacturer publishes the list-cost and assistance information and has a direct commercial interest in product access.
What this source supports
Supports only the dated manufacturer list-cost and savings-program snapshot.
What it does not support
It does not establish a pharmacy price, insurance coverage, eligibility, or an individual out-of-pocket amount.
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.
- 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.
- 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.
- 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.
- 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.
- British Journal of Dermatology (Harris JE, 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 Corporation funded the study and states a role in its design, conduct, analysis and manuscript review.
What this source supports
Supports that facial repigmentation was often held for a further year. Among people who had reached near-complete facial repigmentation at Week 52, 38 of 55 randomized to continue ruxolitinib cream and 22 of 56 randomized to vehicle still held at least 75% facial improvement at Week 104.
What it does not support
It does not predict an individual result. Everyone in it had already responded, the rollover design set no sample size for a powered comparison between the two groups, and more people left the withdrawal group than the continuation group.
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 Venereology (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: Incyte Corporation funded the analysis, two of its employees are authors, and it reports the company’s own phase 3 programme.
What this source supports
Supports that repigmentation differed by body region in the pooled phase 3 data, and that hands and feet responded least. At Week 52, among people who applied ruxolitinib cream only, 68.1% reached at least 50% improvement on the head and neck excluding the face, 38.2% on the hands and 29.3% on the feet.
What it does not support
It is a regional breakdown of one company programme reported as a letter, not a trial designed to compare body areas or to compare this cream with anything else. It does not predict what any one area will do.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.