A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-11

Study Completion Date

2025-03-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Nonsegmental Vitiligo With Genital Involvement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ruxolitinib Cream

Participants with non-segmental vitiligo with genital involvement will receive ruxolitinib 1.5% cream BID for up to 48 weeks

Group Type EXPERIMENTAL

Ruxolitinib Cream

Intervention Type DRUG

Ruxolitinib cream will be applied twice daily for upto 48 weeks

Interventions

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Ruxolitinib Cream

Ruxolitinib cream will be applied twice daily for upto 48 weeks

Intervention Type DRUG

Other Intervention Names

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Opzelura

Eligibility Criteria

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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 interpretation of study data.
* Clinical laboratory test results outside of protocol defined ranges
* Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No