Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)

Launched by INCYTE CORPORATION · Aug 8, 2019

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Eligibility criteria

• 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.