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Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3)

NCT03792516 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-12-04

No results posted yet for this study

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).

Conditions

  • Vulvar Dysplasia
  • HPV-Related Vulvar Intraepithelial Neoplasia
  • Preinvasive Vulvar Disease
  • Vulva Intraepithelial Neoplasia
  • Vulvar Diseases

Interventions

DRUG

artesunate ointment 40%

artesunate formulated as an ointment to be applied topically to the vulva

Sponsors & Collaborators

  • Frantz Viral Therapeutics, LLC

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Cornelia L Trimble, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2022-08-31
Completion
2024-12-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03792516 on ClinicalTrials.gov