A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)

Completed · Phase 2 · Has a placebo group

Conditions studied: Vitiligo

In brief

The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.

Key facts

Study ID

NCT04896385

Run by

Incyte Corporation

People needed

60

Starts

2021-06-23

Expected to finish

2023-07-10

Last updated by the study team

2025-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A clinical diagnosis of nonsegmental vitiligo with depigmented areas including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, and ≥ 3 T-VASI; total body vitiligo area (facial and nonfacial) should not exceed 50% BSA.
• At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance, pinkish rim, or other evidence of inflammatory activity) at the site for skin biopsy.
• 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.

You may not qualify if…

• No pigmented hair within any of the vitiligo areas on the face.
• Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
• Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas except hydroquinone.
• Any other skin disease that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
• Conditions at baseline that would interfere with evaluation of vitiligo.
• Use of any protocol-defined treatments within the indicated washout period before baseline.

Where it is running

• First Oc Dermatology — Fountain Valley, California, United States
• UC Irvine — Irvine, California, United States
• George Washington Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Suny Downstate Medical Center — Brooklyn, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• Dermatology Specialists of Spokane — Spokane, Washington, United States
• Dermatology Research Institute — Calgary, Alberta, Canada
• Simcoderm Medical and Surgical Dermatology Center — Barrie, Ontario, Canada
• Lynderm Research Inc — Markham, Ontario, Canada
• JRB Research Inc — Ottawa, Ontario, Canada
• Hopital Saint Andre — Bordeaux, France
• Centre Hospitalier Universitaire Henri Mondor — Créteil, France
• Hopital Archet 2 Derm Dept — Nice, France

Full record on ClinicalTrials.gov

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