A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus

Completed · Phase 2

Conditions studied: Lichen Sclerosus

In brief

The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants With Lichen Sclerosus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 12 weeks followed by an open label period (OLE) period of 12 weeks.

Key facts

Study ID

NCT05593445

Run by

Incyte Corporation

People needed

61

Starts

2022-11-18

Expected to finish

2023-12-21

Last updated by the study team

2024-09-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy-proven LS in the anogenital area.
• Baseline IGA score ≥ 2 for LS.
• Baseline Itch NRS score ≥ 4 in anogenital area.
• Willingness to avoid pregnancy.

You may not qualify if…

• Participants who do not have LS involving anogenital area.
• Concurrent conditions and history of other diseases:
• 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.
• Have active genital/vulvar lesions at screening and Day 1, not related to LS
• 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..
• Other exclusion criteria may apply.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.