Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants
Frantz Viral Therapeutics, LLC · with Laser Surgery Care, LLC, Anal Dysplasia Clinic MidWest · NCT06206564
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 48
- US sites recruiting
- 2
- Study start
- January 12, 2024
- Record last updated
- May 18, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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)
Being studied: Artesunate ointment; Placebo
Conditions: Anal High-grade Squamous Intraepithelial Lesion; Anal HSIL; Anal HPV Infection; AIN
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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:
- Serum alanine transaminase (SGPT/ALT) \< 5 x upper limit of normal (ULN)
- Serum aspartate transaminase (SGOT/AST) \< 5 x ULN
- Serum Bilirubin (total) \< 2.5 x ULN
- Serum Creatinine ≤ 1.5 x ULN
- Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.
- Weight ≥ 50kg
Exclusion Criteria
- 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
Recruiting US locations
Anal Dysplasia Clinic MidWest
Chicago, IL 60614
Site contact: Gary Bucher, MD · 312-623-2625 · garybuchermd@adcmidwest.com
Laser Surgery Care
New York, NY 10011
Site contact: Taylor Ridley · 212-242-6500 · tridley@lasersurgerycare.com
Study contacts (from the official record)
- Mihaela Plesa · 440-255-1155 · fvtinfo@frantzgroup.com
- Ahmad Bayat, MD · 301-956-2523 · ahmadb@amarexcro.com