CompletedPhase 2

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

United States61 participantsStarted 2022-11-18

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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Exclusion criteria

✕. 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.

What they're measuring

Percentage of Participants With ITCH4 at Week 12

Timeframe: Baseline; Week 12

Trial details

NCT IDNCT05593445

SponsorIncyte Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-01

Results submitted2024-08-29

View on ClinicalTrials.gov More Lichen Sclerosus trials