Status:
COMPLETED
Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)
Lead Sponsor:
Incyte Corporation
Conditions:
Non-segmental Vitiligo
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 (facia...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2021
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT04052425
Start Date
September 20 2019
End Date
October 21 2021
Last Update
August 22 2025
Active Locations (57)
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1
Cahaba Dermatology
Hoover, Alabama, United States, 35244
2
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Scottsdale, Arizona, United States, 85260
3
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
4
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