A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo (NCT05750823) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo
United States49 participantsStarted 2023-04-11
Plain-language summary
An open-label study in which participants with non-segmental vitiligo with genital involvement will apply ruxolitinib 1.5% cream twice a day (BID) to all depigmented areas (up to 10% BSA) for up to 48 weeks. Participants should continue to treat depigmented areas identified for treatment at baseline regardless of whether the area begins to improve or fully repigment.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of nonsegmental vitiligo with genital involvement
* At least ≥ 0.25% BSA of nonsegmental vitiligo in the genital area.
* Pigmented hair within some of the genital vitiligo areas.
* At least 1 genital target lesion that is ≥ 0.1% BSA that has a pigmented hair within it.
* Vitiligo on areas of the body besides the genitals.
* Total body vitiligo area not exceeding 10% BSA.
* Willing to have genital photography conducted.
* Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
Exclusion Criteria:
* Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders.
* Prior or current use of depigmentation treatments (eg, monobenzone).
* Active or recurrent genital warts or herpes.
* Male participants with partners with known current/active cervical intraepithelial neoplasia or anal intraepithelial neoplasia.
* An active sexually transmitted disease, sexually transmitted infection, or other skin disorder affecting the genital area (eg, scabies, fungal infection, molluscum).
* Had ≥ 3 laser hair removal treatments in an area to be treated for vitiligo.
* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study or in…
What they're measuring
1
Percentage of Participants Achieving a Genital Vitiligo Noticeability Scale (VNS) of "4 - A Lot Less Noticeable" or "5 - No Longer Noticeable" at Week 48