MedTrace Logo

Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants

NCT06206564 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-05-18

No results posted yet for this study

Summary

This is a phase II double blind, placebo-controlled, randomized study of artesunate ointment for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)

Conditions

  • Anal High-grade Squamous Intraepithelial Lesion
  • Anal HSIL
  • Anal HPV Infection
  • AIN

Interventions

DRUG

Artesunate ointment

Four 5-day cycles of artesunate ointment given at weeks 0, 2, 4, 6

DRUG

Placebo

Four 5-day cycles of placebo ointment given at weeks 0, 2, 4, 6

Sponsors & Collaborators

  • Laser Surgery Care, LLC

    collaborator UNKNOWN

  • Anal Dysplasia Clinic MidWest

    collaborator UNKNOWN

  • Frantz Viral Therapeutics, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-12
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT06206564 on ClinicalTrials.gov