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Anti-metabolites

Artesunate Ointment for Anal Intraepithelial Lesions (ART-AIN IIB-2 Trial)

Phase 2
Recruiting
Research Sponsored by Frantz Viral Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biopsy-confirmed intra-anal high-grade dysplasia (AIN 2, AIN 3, anal HSIL) by HRA
Positive anal human papillomavirus (HPV) test
Must not have
Concurrent anal, vulvar, cervical, or penile cancer
HIV-seropositivity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 weeks

Summary

This trial is testing a type of ointment called artesunate on HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL). The study is

Who is the study for?
This trial is for HIV-negative men and women with high-grade squamous lesions in the anal area, which can be precursors to cancer. Participants should not have HPV-related conditions elsewhere like genital warts or cervical lesions.
What is being tested?
The study tests artesunate ointment against a placebo (inactive substance) to see if it's effective in treating anal HSIL. It's a phase II trial where participants are randomly assigned to receive either the real ointment or placebo without knowing which one they get.
What are the potential side effects?
Specific side effects of artesunate ointment aren't detailed here, but common ones may include local skin reactions like redness, itching, or irritation at the site of application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My biopsy showed high-grade anal precancer.
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I have tested positive for anal HPV.
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I weigh at least 50kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cancer in the anal, vulvar, cervical, or penile area.
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I am HIV positive.
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I am using imiquimod or 5-FU during the study.
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I am currently undergoing chemotherapy or radiation for another cancer.
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I am not taking strong UGT inhibitors.
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I have a low-grade anal precancerous condition without any high-grade lesions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete and partial response by week 18
Secondary study objectives
Complete and partial peri-anal response after intra-anal ointment application
Complete and partial response after week 18
HPV clearance
+1 more
Other study objectives
Safety of intra-anal artesunate ointment

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ArtesunateExperimental Treatment1 Intervention
Group II: Placebo ointmentPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Laser Surgery Care, LLCUNKNOWN
Frantz Viral Therapeutics, LLCLead Sponsor
5 Previous Clinical Trials
186 Total Patients Enrolled
Anal Dysplasia Clinic MidWestUNKNOWN
1 Previous Clinical Trials
48 Total Patients Enrolled
~27 spots leftby Dec 2025
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