Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3) (NCT03792516) | Clinical Trial Compass
CompletedPhase 1
Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3)
United States15 participantsStarted 2019-04-17
Plain-language summary
This is a Phase I, proof-of-concept treatment study to evaluate the safety, tolerability and feasibility of topical artesunate ointment to treat high grade vulvar intraepithelial neoplasia (HSIL VIN2/3).
Who can participate
Age range18 Years ā 100 Years
SexFEMALE
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Inclusion Criteria:
* Colposcopically-directed biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease.
* Females of childbearing potential: negative urine pregnancy test
* Ability to provide informed consent
* Ability to collaborate with planned follow-up (transportation, compliance history, etc.)
* Use of contraception through the study exit visit (week 28)
Exclusion Criteria:
* Concomitant use of any topical immune modulating agents e.g. imiquimod, Aldara Ā®
* Cluster of differentiation 4 (CD4) count \< 200 at the time of screening for eligibility.
* Unable to provide informed consent
* Currently receiving systemic chemotherapy or radiation therapy for another cancer.
* Pregnant females
* Concurrent dermatological disorders involving the vulva (i.e., herpes, ulceration secondary to Crohn's disease) or vulvar dermatosis (i.e., lichen planus, lichen sclerosus, or lichen simplex chronicus);
* Women weighing less than 50 kg
What they're measuring
1
Safety and tolerability of artesunate ointment applied topically on VIN2/3 lesions as assessed by number of participants experiencing serious adverse events or dose-limiting toxicities
Timeframe: 15 weeks
Trial details
NCT IDNCT03792516
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins