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Cream shows promise for genital vitiligo in early trial

NCT ID NCT05750823

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a cream called ruxolitinib (Opzelura) on 49 people with nonsegmental vitiligo affecting the genitals. Participants applied the cream twice daily for up to 48 weeks to see if it made the white patches less noticeable. The study measured success based on patient reports of how noticeable the vitiligo was compared to before treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ruxolitinib cream (Opzelura)
What this could lead to
If successful, this could offer a topical treatment option for genital vitiligo, potentially reducing the appearance of white patches.
What could go wrong
This is a small, early-phase trial with no placebo group, so results may not be conclusive. Side effects like skin irritation are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

49 people

The number who actually took part.

Started

Apr 2023

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

vitiligo

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nonsegmental vitiligo with genital involvement

Contacts and locations

Locations

  • Apex Clinical Research Center

    Mayfield, Ohio, 44124, United States

  • Austin Institute For Clinical Research Aicr Pflugerville

    Pflugerville, Texas, 78660, United States

  • Center For Dermatology Clinical Research, Inc

    Fremont, California, 94538, United States

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33075, France

  • Chu Nice Hopital Archet 2

    Nice, 06202, France

  • Dermatology Research Institute

    Calgary, Alberta, T2J 7E1, Canada

  • Hamzavi Dermatology

    Fort Gratiot, Michigan, 48059-3526, United States

  • Hopital Henri Mondor Service de Dermatologie

    Créteil, 94000, France

  • Innovative Dermatology: Legacy Medical Village

    Plano, Texas, 75024-4319, United States

  • Research Toronto

    Toronto, Ontario, M3H 5Y8, Canada

  • Simcomed Health Ltd

    Barrie, Ontario, L4M 7G1, Canada

  • Skin Centre For Dermatology

    Peterborough, Ontario, K9J 5K2, Canada

  • Vitiligo & Pigmentation Institute of Southern California

    Los Angeles, California, 90036, United States