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Janus Kinase (JAK) Inhibitor
Ruxolitinib Cream + Phototherapy for Vitiligo
Phase 2
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 14 months
Awards & highlights
Study Summary
This trial will study whether Ruxolitinib cream, with or without phototherapy, can help treat vitiligo in people for whom the affected area does not exceed 10% of their body.
Who is the study for?
This trial is for adolescents and adults with non-segmental vitiligo, where the affected area doesn't cover more than 10% of their body. Participants should have a certain level of facial and body depigmentation. They must stop other vitiligo treatments during the study and can't join if they have skin infections, other skin diseases, serious health issues, no pigmented hair in vitiligo areas on the face, used certain past treatments or had bad reactions to phototherapy.Check my eligibility
What is being tested?
The trial tests Ruxolitinib cream's effectiveness and safety when used alone or combined with NB-UVB phototherapy for treating non-segmental vitiligo. It focuses on participants whose condition affects less than 10% of their body surface area.See study design
What are the potential side effects?
Potential side effects may include local skin reactions at the application site such as redness, itching or irritation. Systemic side effects are not detailed but could be similar to those seen with other topical medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 14 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 14 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in T-VASI
Secondary outcome measures
Number of treatment-related adverse events
Percentage change from baseline in F-BSA at each post-baseline visit
Percentage change from baseline in F-VASI at each post-baseline visit
+5 moreSide effects data
From 2016 Phase 4 trial • 97 Patients • NCT015530589%
upper respiratory infection
6%
vasovagal syncope
6%
joint range of motion decrease
3%
nasal congestion
3%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adalimumab (Humira)
Placebo Injection
NB-UVB Phototherapy
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group B: Ruxolitinib MonotherapyExperimental Treatment1 Intervention
Participants will apply ruxolitinib 1.5% cream BID as monotherapy. Participants who have ≥ T-VASI25 at Week 12 will continue on ruxolitinib 1.5% cream BID alone.
Group II: Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB)Experimental Treatment2 Interventions
Participants will initially apply ruxolitinib 1.5%mg cream as a monotherapy. At week 12, those who have < 25% improvement in total body Vitiligo Area Scoring Index (T-VASI25) will have NB-UVB phototherapy added to their ruxolitinib 1.5% cream BID regimen. NB-UVB will be given 3 times per week starting at Week 12 through Week 48 (36 weeks). For participants who receive combination therapy, NB-UVB machines will be supplied by the sponsor for at home use during the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NB-UVB phototherapy
2017
Completed Phase 4
~150
Who is running the clinical trial?
Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,110 Total Patients Enrolled
9 Trials studying Vitiligo
2,457 Patients Enrolled for Vitiligo
Haq Nawaz, MDStudy DirectorIncyte Corporation
5 Previous Clinical Trials
202 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a skin condition called nonsegmental vitiligo with a large depigmented area.You have a score of 0.5 or higher on the F-VASI scale for facial skin condition.You have large areas of vitiligo on your body, not including your face.You have a current bacterial, fungal, or viral skin infection.You have a skin condition that might make it hard to use the study cream or affect the study evaluations.You did not see much improvement in your skin condition after a certain kind of light therapy.You do not have any dark-colored hair in the areas affected by vitiligo on your face.You have a different type of vitiligo or a different condition that causes loss of skin color.You have used depigmentation treatments like monobenzone for vitiligo or other skin conditions in the past.You had a bad reaction to NB-UVB phototherapy and had to stop it.You have been diagnosed with nonsegmental vitiligo and have a depigmented area larger than 0.5 on your face.The total area of vitiligo on your body, including your face and other areas, is not more than 10% of your total body surface area.You have been diagnosed with nonsegmental vitiligo and have depigmented areas covering a certain amount of your body.You need to have certain blood test results within a specific range set by the study.You have a history of blood clots, stroke, or heart attack.You have less than 10% of your body covered by vitiligo.
Research Study Groups:
This trial has the following groups:- Group 1: Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB)
- Group 2: Group B: Ruxolitinib Monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Vitiligo Patient Testimony for trial: Trial Name: NCT05247489 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible to partake in this research endeavor?
"This clinical trial is seeking 50 vitiligo sufferers between the ages of 12 and 99, who have at least 0.5 F-VASI on their face and 3.0 T-VASI in other body areas. The total area of skin affected must not exceed 10% BSA, while participants are asked to discontinue all forms of treatment from screening through the final safety follow up visit; though camouflage makeup and over-the counter preparations deemed acceptable by investigators are allowed for use."
Answered by AI
Is this experiment allowing individuals of advanced age to participate?
"Those who meet the criteria for participation in this medical trial must be between 12 and 99 years of age. There are 8 clinical trials available to those below 18, while 36 studies are specified for applicants aged 65 or older."
Answered by AI
Are there any current opportunities to register for this trial?
"As evidenced by the details on clinicaltrials.gov, this medical investigation is currently recruiting participants. It was initially advertised on May 5th 2022 and subsequently updated October 6th of that same year."
Answered by AI
How many participants have registered for this experiment?
"The trial necessitates 50 participants to meet the required criteria. Patients may participate from either UC Davis Health in Sacramento, California or Lynderm Research Inc in Markham, Ontario."
Answered by AI
To what extent are people at risk for adverse effects from NB-UVB phototherapy?
"NB-UVB phototherapy has been previously tested for safety, giving it a rating of 2 on our scale. Unfortunately, there is no evidence to suggest how effective this intervention could be at treating the target condition."
Answered by AI
How many research facilities have implemented this trial?
"At the time of this writing, 14 centres are participating in the trial. Participants can select to visit one of these sites closest to them which include Sacramento, Markham and Fountain Valley among other cities. This is done with convenience in mind for those taking part in the study."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Washington
Massachusetts
Other
How old are they?
65+
18 - 65
What site did they apply to?
UC Davis Health
Delricht Clinical Research - Clinedge - Ppds Baton Rouge
University of Massachusetts Medical School
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
3+
0
Why did patients apply to this trial?
I'm hoping this clinical trial can help my condition vitiligo. I want to be able to leave the house and not be so self conscious about the lose of pigment on my face, neck and upper back.
PatientReceived 2+ prior treatments
I have tried several medications but they did not work. Now I want to be part of a population that may help bring hope to Vitiligo patients.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
What is time frame for the sessions and the frequency? How long does it last, are there any serious negative side effects that could result and how long would I be required to be out there during a visit?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Tufts Medical Center: < 24 hours
Average response time
- < 2 Days
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