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)

Recruiting Phase 2 Interventional Study
Vulvar Diseases HPV Infection Vulvar HSIL Pre-Cancerous Dysplasia HPV Disease VIN, Usual Type VIN 2 of Usual Type VIN 3 of Usual Type Vin II Vin III VIN Grade 2 VIN Grade 3 High Grade Intraepithelial Neoplasia
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
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
Who this trial is looking for

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.

Are You a Good Fit for This Trial?

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.

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About This Trial

This 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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Adult women age ≥ 18 years * Capable of informed consent * Able to collaborate with planned follow-up (transportation, compliance history, etc) * Biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease. A biopsy diag…
Contacts

Mihaela Plesa

440-255-1155

fvtinfo@frantzgroup.com

CONTACT

Ahmad Bayat, MD

301-956-2523

CONTACT