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Artesunate Ointment for Anal HSIL in HIV-negative Individuals

This study is testing an ointment called artesunate for treating Anal High-grade Squamous Intraepithelial Lesion (Anal HSIL), which are abnormal cell changes in the anal area. It's for adults who do not have HIV and have biopsy-confirmed HSIL and a positive HPV test. Researchers want to see if artesunate ointment can reduce or clear these abnormal cells. You would receive either artesunate ointment or a placebo (an inactive ointment) for four short periods over six weeks. The main goal is to measure how many participants have a complete or partial response by week 18. The study status is currently unclear.

Study design
This is a randomized, double-blind study involving 48 participants. Participants will be randomly assigned to receive either artesunate ointment or a placebo.
What's involved
You would apply ointment for four 5-day cycles over six weeks. You would also have follow-up visits with anoscopy or high-resolution anoscopy (HRA) at weeks 8, 18, 30, and 42.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed closely with anoscopy or HRA at weeks 8, 18, 30, and 42 after treatment.

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NCT06206564

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Frantz Viral Therapeutics, LLC
~48 participants
Updated 2025-05-18 on ClinicalTrials.gov
What's tested:Artesunate ointmentPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete and partial response by week 18
Measured over 18 weeks

Conditions

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

Explore related trials

Anal InfectionHigh Grade Squamous Intraepithelial NeoplasiaHPV

Where it's being run

2 sites across 2 states
Illinois1
New York1

Who to contact

Mihaela Plesa
[email protected]
440-255-1155
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult men and women age ≥ 18 years
Capable of informed consent
Biopsy-confirmed intra-anal high-grade dysplasia (AIN 2, AIN 3, anal HSIL) by HRA.
Positive anal human papillomavirus (HPV) test.
Women of childbearing potential agree to use birth control for the duration of the study.
Laboratory values at Screening of:
Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.
Weight ≥ 50kg

Exclusion

Pregnant and nursing women
Diagnosis of low-grade anal dysplasia (AIN 1, LSIL), without the concomitant diagnosis of anal HSIL, by HRA
Concurrent anal, vulvar, cervical, or penile cancer
HIV-seropositivity
Currently receiving systemic chemotherapy or radiation therapy for another cancer.
Patients who are on medical treatment with systemic immunosuppressants or steroids (e.g., active autoimmune disease). Participants using nasal steroid treatments for allergic conditions may participate in the study.
Concomitant use of strong UGT (Uridine-diphosphate-glucuronosyltransferase) inhibitors
Concomitant use of imiquimod or 5-fluorouracil (5-FU) for the duration of the study

What this trial measures

  • Complete and partial response by week 1818 weeks

    Number of participants with complete and partial response after four 5-day cycles of artesunate ointment