A Study to Evaluate Platelet Rich Plasma to Treat Vulvar Lichen Sclerosus (NCT04967170) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study to Evaluate Platelet Rich Plasma to Treat Vulvar Lichen Sclerosus
United States30 participantsStarted 2022-01-19
Plain-language summary
The purposes of this study are to determine the safety and feasibility of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus, and to determine the efficacy of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria
* Female, ages 18 years and greater.
* Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit.
* Females becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
* Diagnosis of Lichen Sclerosus.
* On a maintenance regimen of topical clobetasol for Lichen Sclerosus. Maintenance is defined as use of topical clobetasol 3 or fewer days per week. For patients with a new diagnosis of Lichen Sclerosus, they will complete 6 weeks of topical clobetasol ointment twice daily prior to enrollment in the…