Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2) (NCT04057573) | Clinical Trial Compass
CompletedPhase 3
Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)
United States344 participantsStarted 2019-10-03
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).
Who can participate
Age range12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI, and 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.
* Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.
Key Exclusion Criteria:
* 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).
* Have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
* Use of protocol-defined treatments within the indicated washout period before baseline.
What they're measuring
1
Percentage of Participants Achieving a ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24