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Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)

NCT06075264 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-08-14

No results posted yet for this study

Summary

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).

Conditions

  • 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

Interventions

DRUG

Artesunate ointment

topical ointment, as a non-surgical treatment

DRUG

Placebo ointment

topical placebo ointment

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Frantz Viral Therapeutics, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-06
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06075264 on ClinicalTrials.gov