Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo
Lead Sponsor:
Incyte Corporation
Conditions:
Vitiligo
Eligibility:
All Genders
12-99 years
Phase:
PHASE2
Brief Summary
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 ar...
Eligibility Criteria
Inclusion
- 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.
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.
- 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.
Key Trial Info
Start Date :
May 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2023
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT05247489
Start Date
May 5 2022
End Date
December 19 2023
Last Update
February 20 2025
Active Locations (13)
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1
First Oc Dermatology
Fountain Valley, California, United States, 92708
2
UC Davis Health
Sacramento, California, United States, 95816
3
Palo Alto Medical Foundation
Sunnyvale, California, United States, 94086
4
Delricht Clinical Research - Clinedge - Ppds Baton Rouge
Baton Rouge, Louisiana, United States, 70809