A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo
Key facts
- Who runs it
- Incyte Corporation
- Where
- Baton Rouge, Boston, Brighton, Detroit, Fountain Valley, Pflugerville, Rockville, Sacramento, Spokane, Sunnyvale, and Worcester, United StatesSee the 11 sitesAlso in 1 other country, 2 sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 55 people enrolled
- Started
- 5 May 2022
- Ended
- 19 Dec 2023
- Type of study
- Interventional, 2 groups
- Treatments tested
- Ruxolitinib 1.5% cream
- NB-UVB phototherapy
- Record updated
- 20 February 2025
Who can take part
- Age
- 12 years to 99 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous adverse reaction to NB-UVB phototherapy that caused discontinuation of therapy
- Lack of response (little or no repigmentation) to prior NB-UVB phototherapy
- Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox) within 1 week before baseline
- 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
- Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders
- 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
- 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
- Specific protocol-defined chemistry, hematology, and serological lab values
- No pigmented hair within any of the vitiligo areas on the face
- Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas
- Those who are pregnant, lactating or considering pregnancy during the period of study participation
Where in United States
Also in 1 other country, 2 sites
- Delricht Clinical Research-Clinedge-Ppds Baton RougeBaton Rouge, United States
- Tufts Medical CenterBoston, United States
- Metro Boston Clinical PartnersBrighton, United States
- Henry Ford Medical Center - New Center OneDetroit, United States
- First OC DermatologyFountain Valley, United States
- Austin Institute For Clinical Research Aicr PflugervillePflugerville, United States
- Aesthetic and Dermatology CenterRockville, United States
- UC Davis HealthSacramento, United States
- Principle Research SolutionsSpokane, United States
- Palo Alto Medical FoundationSunnyvale, United States
- University of Massachusetts Medical SchoolWorcester, United States
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB)Treatment being tested
Participants will initially apply ruxolitinib 1.5%mg cream as a monotherapy. At week 12, those who have \< 25% improvement in total body Vitiligo Area Scoring Index (T-VASI25) will have NB-UVB phototherapy added to their ruxolitinib 1.5% cream BID regimen. NB-UVB will be given 3 times per week starting at Week 12 through Week 48 (36 weeks). For participants who receive combination therapy, NB-UVB machines will be supplied by the sponsor for at home use during the study.
Treatment: Ruxolitinib 1.5% cream and NB-UVB phototherapy
- Group B: Ruxolitinib MonotherapyTreatment being tested
Participants will apply ruxolitinib 1.5% cream BID as monotherapy. Participants who have ≥ T-VASI25 at Week 12 will continue on ruxolitinib 1.5% cream BID alone.
Treatment: Ruxolitinib 1.5% cream
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Safety and Efficacy Study of Ruxolitinib Cream Combined With Narrow-Band Ultraviolet B Phototherapy in Participants With Vitiligo
- Record updated
- 20 February 2025