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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
Must not have
An active sexually transmitted disease, sexually transmitted infection, or other skin disorder affecting the genital area (eg, scabies, fungal infection, molluscum)
Active or recurrent genital warts or herpes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24 and 48
Awards & highlights

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 below
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I have vitiligo on parts of my body other than the genitals.
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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.
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I have vitiligo that affects my genital area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any active STDs or skin disorders affecting my genital area.
Select...
I currently have or recently had genital warts or herpes.
Select...
I have used treatments to lighten my skin.
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I have a type of vitiligo or a similar skin condition.
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My partner has an active cervical or anal pre-cancer condition.
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I've had 3 or more laser hair removal sessions on the area affected by vitiligo.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24 and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 and 48 for reporting.

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 more

Side effects data

From 2020 Phase 3 trial • 631 Patients • NCT03745638
9%
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
JAK inhibitors like Ruxolitinib 1.5% cream work by blocking the Janus kinase pathways involved in the immune response that leads to melanocyte destruction in non-segmental vitiligo. This inhibition reduces inflammation and halts the autoimmune attack on melanocytes, allowing for potential repigmentation. Understanding this mechanism is crucial for patients as it highlights the importance of targeting specific immune pathways to manage the condition effectively. Other treatments, such as corticosteroids and phototherapy, also aim to reduce inflammation and promote repigmentation but through different mechanisms, offering various approaches to disease management.

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
373 Previous Clinical Trials
55,730 Total Patients Enrolled

Media Library

Ruxolitinib Cream (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05750823 — Phase 2
Non-segmental Vitiligo Research Study Groups: Ruxolitinib Cream
Non-segmental Vitiligo Clinical Trial 2023: Ruxolitinib Cream Highlights & Side Effects. Trial Name: NCT05750823 — Phase 2
Ruxolitinib Cream (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05750823 — Phase 2
Non-segmental Vitiligo Patient Testimony for trial: Trial Name: NCT05750823 — Phase 2
~22 spots leftby Aug 2025