A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo
A legfontosabb adatok
- Ki végzi
- Incyte Corporation
- Hol
- Baton Rouge, Boston, Brighton, Detroit, Fountain Valley, Pflugerville, Rockville, Sacramento, Spokane, Sunnyvale és Worcester (Egyesült Államok)Mind a 11 helyszín megnézéseMég 1 másik országban, 2 helyszínen
- Azonosító
- Állapot
- Befejeződött
- Fázis
- 2. fázis
- Résztvevők
- 55 fő vett részt
- Kezdés
- 2022. máj. 5.
- Befejezés
- 2023. dec. 19.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- Ruxolitinib 1.5% cream
- NB-UVB phototherapy
- A regiszteradat frissítve
- 2025. február 20.
Ki vehet részt
- Életkor
- 12 év – 99 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
Helyszínek itt: Egyesült Államok
Még 1 másik országban, 2 helyszínen
- Delricht Clinical Research-Clinedge-Ppds Baton RougeBaton Rouge, Egyesült ÁllamokNo longer taking part
- Tufts Medical CenterBoston, Egyesült ÁllamokNo longer taking part
- Metro Boston Clinical PartnersBrighton, Egyesült ÁllamokNo longer taking part
- Henry Ford Medical Center - New Center OneDetroit, Egyesült ÁllamokNo longer taking part
- First OC DermatologyFountain Valley, Egyesült ÁllamokNo longer taking part
- Austin Institute For Clinical Research Aicr PflugervillePflugerville, Egyesült ÁllamokNo longer taking part
- Aesthetic and Dermatology CenterRockville, Egyesült ÁllamokNo longer taking part
- UC Davis HealthSacramento, Egyesült ÁllamokNo longer taking part
- Principle Research SolutionsSpokane, Egyesült ÁllamokNo longer taking part
- Palo Alto Medical FoundationSunnyvale, Egyesült ÁllamokNo longer taking part
- University of Massachusetts Medical SchoolWorcester, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
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).
A vizsgálat 2 csoportja
- Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB)A vizsgált kezelés
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.
Kezelés: Ruxolitinib 1.5% cream és NB-UVB phototherapy
- Group B: Ruxolitinib MonotherapyA vizsgált kezelés
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.
Kezelés: Ruxolitinib 1.5% cream
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- A Safety and Efficacy Study of Ruxolitinib Cream Combined With Narrow-Band Ultraviolet B Phototherapy in Participants With Vitiligo
- A regiszteradat frissítve
- 2025. február 20.