Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Incyte Corporation
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible 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 be if
Participants who do not have LS involving anogenital area.
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..
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