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Janus Kinase (JAK) Inhibitor
Ruxolitinib Cream 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
Vitiligo on areas of the body besides the genitals
At least 1 genital target lesion that is ≥ 0.1% BSA that has a pigmented hair within it
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24 and 48
Awards & highlights
Study Summary
This trial tests a cream that might help repigment skin affected by vitiligo, used twice a day for up to 48 weeks.
Who is the study for?
This trial is for individuals with non-segmental vitiligo affecting the genital area, covering no more than 10% of their body. Participants must have at least one target lesion in the genital area with pigmented hair and be willing to undergo genital photography. Pregnant or breastfeeding individuals, those considering pregnancy, or people with other skin conditions are excluded.Check my eligibility
What is being tested?
The study tests Ruxolitinib Cream applied twice daily to depigmented areas including genitals for up to 48 weeks. The goal is to assess its safety and effectiveness in restoring pigment. It's an open-label trial where all participants know they're using this specific cream.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of topical treatments like Ruxolitinib Cream may include skin irritation, redness, itching at the application site, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have vitiligo on parts of my body other than the genitals.
Select...
I have a genital lesion larger than 0.1% of my body surface area with a pigmented hair.
Select...
Less than 10% of my body is affected by vitiligo.
Select...
I have vitiligo covering more than 0.25% of my body, including the genital area.
Select...
I have vitiligo that affects my genital area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24 and 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24 and 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change from baseline in affected Body Surface Area BSA in the genital region
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Proportion of participants achieving Genital- Physician Global Vitiligo Assessment (PhGVA)
+3 moreSide effects data
From 2020 Phase 3 trial • 631 Patients • NCT037456389%
Upper respiratory tract infection
6%
Nasopharyngitis
4%
Headache
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib 0.75% Cream BID
Vehicle Cream BID
Ruxolitinib 1.5% Cream BID
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ruxolitinib CreamExperimental Treatment1 Intervention
Participants with non-segmental vitiligo with genital involvement will receive ruxolitinib 1.5% cream BID for up to 48 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib Cream
2018
Completed Phase 3
~640
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,104 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any active STDs or skin disorders affecting my genital area.I have vitiligo on parts of my body other than the genitals.I agree to stop all vitiligo treatments except for certain over-the-counter products and makeup.Less than 10% of my body is affected by vitiligo.I currently have or recently had genital warts or herpes.I have a genital lesion larger than 0.1% of my body surface area with a pigmented hair.I have used treatments to lighten my skin.I have vitiligo covering more than 0.25% of my body, including the genital area.I have a type of vitiligo or a similar skin condition.My partner has an active cervical or anal pre-cancer condition.I have vitiligo that affects my genital area.I've had 3 or more laser hair removal sessions on the area affected by vitiligo.Your lab test results are not within the specified normal ranges for the study.You have dark hair in some of the white patches on your genitals.
Research Study Groups:
This trial has the following groups:- Group 1: Ruxolitinib Cream
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.
Non-segmental Vitiligo Patient Testimony for trial: Trial Name: NCT05750823 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA authorized Ruxolitinib Cream for therapeutic use?
"According to the assessments made by our team at Power, Ruxolitinib Cream was given a score of 2 on a scale from 1-3. This is because there are preliminary indications that it is safe but no data confirming its efficacy in this Phase 2 trial."
Answered by AI
Are there still openings for research participants in this clinical trial?
"Affirmative. Clinicaltrials.gov reveals that this medical study, which was initially listed on April 11th 2023, is actively recruiting volunteers. A total of 30 patients are needed to be recruited across 13 seperate sites."
Answered by AI
How many individuals have volunteered to partake in this experiment?
"This clinical trial necessitates 30 participants meeting the set of established inclusion criteria. Patients can join from either Vitiligo & Pigmentation Institute of Southern California in Los Angeles, Michigan or Hamzavi Dermatology in Fort Gratiot, Ohio."
Answered by AI
In how many geographic locations is this trial taking place?
"13 sites across the United States of America are currently running this clinical trial. These locations include Los Angeles, Fort Gratiot and Mayfield with additional centres situated in other cities. To reduce travel demands for potential participants it is wise to select a nearby site."
Answered by AI
Who else is applying?
What state do they live in?
Ontario
New York
What site did they apply to?
Apex Clinical Research Center
Innovative Dermatology: Legacy Medical Village
Toronto Research Cenre
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
I’ve tried drugs with little or no success.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Toronto Research Cenre: < 48 hours
Average response time
- < 2 Days
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