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

Last updated: April 9, 2025
Sponsor: Incyte Corporation
Overall Status: Completed

Phase

2

Condition

Vitiligo

Treatment

Ruxolitinib Cream

Clinical Study ID

NCT05750823
INCB 18424-219
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 withinit.

  • 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 throughthe final safety follow-up visit. Over-the-counter preparations deemed acceptable bythe investigator and camouflage makeups are permitted.

Exclusion

Exclusion Criteria:

  • Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligoor 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 intraepithelialneoplasia or anal intraepithelial neoplasia.

  • An active sexually transmitted disease, sexually transmitted infection, or otherskin 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 theinvestigator's opinion, would interfere with full participation in the study orinterpretation of study data.

  • Clinical laboratory test results outside of protocol defined ranges

  • Pregnant or lactating participants, or those considering pregnancy during the periodof their study participation.

Study Design

Total Participants: 49
Treatment Group(s): 1
Primary Treatment: Ruxolitinib Cream
Phase: 2
Study Start date:
April 11, 2023
Estimated Completion Date:
March 06, 2025

Connect with a study center

  • Dermatology Research Institute

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Simcomed Health Ltd

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Skin Centre For Dermatology

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • Research Toronto

    Toronto, Ontario M3H 5Y8
    Canada

    Site Not Available

  • Toronto Research Cenre

    Toronto, Ontario M3H 5Y8
    Canada

    Active - Recruiting

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33075
    France

    Site Not Available

  • Centre Universitaire de Bordeaux

    Bordeaux, 33075
    France

    Site Not Available

  • Hopital Henri Mondor Service de Dermatologie

    Creteil, 94000
    France

    Site Not Available

  • Chu Nice Hopital Archet 2

    Nice, 06202
    France

    Site Not Available

  • Center For Dermatology Clinical Research, Inc

    Fremont, California 94538
    United States

    Site Not Available

  • Vitiligo & Pigmentation Institute of Southern California

    Los Angeles, California 90036
    United States

    Site Not Available

  • Hamzavi Dermatology

    Fort Gratiot, Michigan 48059-3526
    United States

    Site Not Available

  • Apex Clinical Research Center

    Mayfield, Ohio 44124
    United States

    Site Not Available

  • Austin Institute For Clinical Research Aicr Pflugerville

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Innovative Dermatology: Legacy Medical Village

    Plano, Texas 75024-4319
    United States

    Site Not Available

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