A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
NCT ID: NCT05593445
Last Updated: 2024-09-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2022-11-18
2023-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ruxolitinib cream
Ruxolitinib 1.5% cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.
Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Vehicle Cream
Vehicle cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.
Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Interventions
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Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Baseline IGA score ≥ 2 for LS.
* Baseline Itch NRS score ≥ 4 in anogenital area.
* Willingness to avoid pregnancy.
Exclusion Criteria
* Concurrent conditions and history of other diseases:
1. Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including: candidiasis, chlamydia trachomatis, trichomonas vaginalis, neisseria gonorrhoeae, bacterial vaginosis, or herpes simplex.
2. Have active genital/vulvar lesions at screening and Day 1, not related to LS
3. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
* Laboratory values outside of the protocol-defined criteria
* Pregnant or lactating participants or those considering pregnancy during the period of their study participation..
18 Years
FEMALE
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Haq Nawaz, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Cahaba Dermatology
Birmingham, Alabama, United States
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States
UC Irvine
Irvine, California, United States
The Centers For Vulvovaginal Disorders
Washington D.C., District of Columbia, United States
New Age Medical Research Corporation
Miami, Florida, United States
Circuit Clinical
West Seneca, New York, United States
Unc Dermatology and Skin Cancer Center At Southern Village
Chapel Hill, North Carolina, United States
Apex Dermatology
Ashtabula, Ohio, United States
Bexley Dermatology
Bexley, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Utah Health Care Midvalley Health Center Dermatology
Murray, Utah, United States
Seattle Skin and Laser Clinic
Seattle, Washington, United States
K. Papp Clinical Research
Waterloo, Ontario, Canada
Clinique Rsf
Québec, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INCB 18424-220
Identifier Type: -
Identifier Source: org_study_id
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