A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo

Completed · Phase 2

Conditions studied: Vitiligo

In brief

The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream with or without phototherapy in adolescent and adult participants with non-segmental vitiligo for whom vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

Key facts

Study ID

NCT05247489

Run by

Incyte Corporation

People needed

55

Starts

2022-05-05

Expected to finish

2023-12-19

Last updated by the study team

2025-02-20

Who can join

Age: 12 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A clinical diagnosis of nonsegmental vitiligo with depigmented area including all of the following:
• ≥ 0.5 F-VASI on the face
• ≥ 3.0 T-VASI (body areas not including the face)
• Total body vitiligo area (facial and nonfacial) not exceeding 10% BSA.
• 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.
• Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
• Previous adverse reaction to NB-UVB phototherapy that caused discontinuation of therapy.
• Lack of response (little or no repigmentation) to prior NB-UVB phototherapy.
• History of thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, ischemic stroke, myocardial infarction).
• Any other skin disease that, in the opinion of the investigator, would interfere with the study cream application or study assessments.
• Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox) within 1 week before baseline.
• Any serious illness or medical, physical, or psychiatric condition(s) that pose a significant risk to the participant; or interfere with interpretation of study data.
• Recent use of topical or systemic medications (including biologics or JAK inhibitors), or laser or phototherapy to treat vitiligo. Note: Recent may be defined differently for different treatments.
• Specific protocol-defined chemistry, hematology, and serological lab values.
• Those who are pregnant, lactating or considering pregnancy during the period of study participation.

Where it is running

• First Oc Dermatology — Fountain Valley, California, United States
• UC Davis Health — Sacramento, California, United States
• Palo Alto Medical Foundation — Sunnyvale, California, United States
• Delricht Clinical Research - Clinedge - Ppds Baton Rouge — Baton Rouge, Louisiana, United States
• Aesthetic and Dermatology Center — Rockville, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Metro Boston Clinical Partners — Brighton, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Henry Ford Medical Center - New Center One — Detroit, Michigan, United States
• Austin Institute For Clinical Research Aicr Pflugerville — Pflugerville, Texas, United States
• Principle Research Solutions — Spokane, Washington, United States
• Simcomed Health Ltd — Barrie, Ontario, Canada
• Lynderm Research Inc — Markham, Ontario, Canada

Full record on ClinicalTrials.gov

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