Testing Ruxolitinib Cream with Vehicle Cream against a placebo for nonsegmental vitiligo
Official title: A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
- Phase 3
- 2 groups
- Sites in St. John's, Calgary and 10 more cities
- Recruiting
Interventions
- Medication
Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
- Medication
Vehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Canadian Sites (19)
17 of 19 recruiting
- Recruiting
Kirk Barber Research
Calgary, Alberta
- Recruiting
Dermatology Research Institute
Calgary, Alberta
- Recruiting
Alberta Health Services (Ahs) - Alberta Children'S Hospital (Ach)
Calgary, Alberta
- Recruiting
Laser Rejuvenation Clinics Edmonton D.T. Inc
Edmonton, Alberta
- Recruiting
Alberta Dermasurgery Centre
Edmonton, Alberta
- Recruiting
Coal Harbour Rejuvenation Dermatology, Inc.
Vancouver, British Columbia
- Recruiting
Winnipeg Clinic
Winnipeg, Manitoba
- Recruiting
Maritime Dermatology
Halifax, Nova Scotia
- Recruiting
Dar Clinical Research Inc
Ottawa, Ontario
- Recruiting
University of Toronto - the Hospital For Sick Children (Sickkids)
Toronto, Ontario
- Recruiting
Cosmetic Dermatology on Bloor
Toronto, Ontario
- Recruiting
Centre de Recherche St-Louis
Montreal, Quebec
- Recruiting
Universite de Montreal - Centre Hospitalier Universitaire (Chu) Sainte-Justine - Centre de Recherche
Montreal, Quebec
- Recruiting
Centre Hospitalier Universitaire de Quebec - Centre Hospitalier de L'Universite Laval (Chul)
Québec, Quebec
- Recruiting
Centre de Recherche Saint-Louis
Québec, Quebec
- Recruiting
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan
- Recruiting
Skincare Studio Dermatology Centre
St. John's
- Not yet recruiting
Skin Physicians
Edmonton, Alberta
- Not yet recruiting
Dermcare Clinic
Mississauga, Ontario
Eligibility Criteria
See who this study is looking for19 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 2% BSA on nonfacial areas, ≥ 2 T-VASI.
- +Total body vitiligo area does not exceed 10% BSA.
- +Pigmented hair within some of the areas of vitiligo on the face.
- +Must agree to discontinue all agents used to treat vitiligo from screeningScreeningThe checks done before joining, to see whether a study fits.Read more → through the final safety follow-up visitFollow-upContinued check-ins after the treatment part is finished.Read more →.
- +For sexually active participants (except participants who are prepubescent) willingness to avoid pregnancy or fathering a child from screening through 30 days after the last application of study cream.
Exclusion
- −Known allergy or reaction to any component of the study cream formulation.
- −Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- −Diagnosis of other forms of vitiligo (eg, segmental).
- −Other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
- −Any other skin disease that, in the opinion of the investigator, would interfere with the study drug application or study assessments.
- −Prior or current use of depigmentation treatments (eg, monobenzone).
- −Use of protocolProtocolThe detailed plan a study must follow.Read more →-defined treatments within the indicated washout periodWashout periodA gap with no treatment, so the previous one clears your system.Read more → before baselineBaselineYour starting measurements, taken before treatment begins.Read more →.
- −History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, and upadacitinib) for vitiligo or any other inflammatory condition.
- −Protocol-defined clinically significant abnormal laboratory values at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −In the opinion of the investigator, unable or unlikely to comply with the application schedule and study evaluations.
- −Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study.
- −Employees of the sponsorSponsorThe organisation responsible for the study overall.Read more → or investigator or are otherwise dependents of them.
- −Other protocol-defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply.
- −Pregnant or lactating participants or those considering pregnancy during the period of their study participation.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Ruxolitinib Cream.
Registry label: A: Ruxolitinib 1.5 % Cream
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Vehicle Cream.
Registry label: B: Vehicle Cream
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 2 years to 11 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 180 people.
The study is currently expected to finish around March 2027.
The main measurement is taken over: Week 24.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Proportion of Participants Achieving a ≥ 75% Improvement From BaselineBaselineYour starting measurements, taken before treatment begins.Read more → in the Facial Vitiligo Area Scoring Index (F-VASI75) — measured over Week 24.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06548360 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Ruxolitinib CreamDrug
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Vehicle CreamDrug
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 2 years to 11 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 2 years to 11 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Week 24.
The study as a whole is currently expected to finish around 2027-03-13.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 180 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 23 locations, including: St. John's, Canada; Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada, and 17 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.
Other Sites (14)
Dermatology and Cosmetic Center
Flint, Michigan, United States
Mi Skin Center, Pllc
Northville, Michigan, United States
Michigan Dermatology Institute
Waterford, Michigan, United States
Boeson Research
Missoula, Montana, United States
Suny Downstate Medical Center
Brooklyn, New York, United States
The Dermatology Specialists Greenwich
New York, New York, United States
Equity Medical, Llc
New York, New York, United States
Mount Sinai Doctors
New York, New York, United States
Sadick Dermatology Sadick Research Group
New York, New York, United States
Skin Search of Rochester
Rochester, New York, United States
Vitality Clinical Research Llc
Woodbury, New York, United States
Frontier Dermatology
Mill Creek, Washington, United States
Seattle Children'S Hospital
Seattle, Washington, United States
Dermatology Specialists of Spokane
Spokane, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.