Artesunate Ointment for Vulvar High Grade Lesions
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 27 (estimated)
- Sponsor
- Frantz Viral Therapeutics, LLC · Industry
This trial is looking for adult women with a diagnosis of high-grade vulvar lesions related to HPV. Participants will apply artesunate ointment and attend follow-up visits to monitor their progress.
You may be able to join if
- I am an adult woman age 18 or older
- I can give my consent to join the study
- I can attend all necessary follow-up appointments
- I have been diagnosed with high-grade vulvar lesions in the last 3 months
- I have tested positive for HPV
- I agree to use birth control during the study if I can get pregnant
- My weight is at least 50kg
You may not be able to join if
- I am pregnant or nursing
- I have anal, vulvar, or cervical cancer
- I am HIV-positive with a low CD4 count
- I am not on stable HIV treatment if infected with HIV-1
- I do not want to have a procedure to remove or check my lesions at week 18
- I am receiving cancer treatment like chemotherapy or radiation
- I have skin conditions affecting my vulva
- I am taking systemic corticosteroids
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your EligibilityThis is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).
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Ahmad Bayat, MD
301-956-2523
CONTACT