Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants
NCT ID: NCT06206564
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
48 participants
INTERVENTIONAL
2024-01-12
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
NCT06075264
Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
NCT03100045
Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3)
NCT03792516
Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
NCT02354534
On the Impact of Therapeutic Tumor Necrosis Factor-alpha Inhibition on Anogenital Human Papillomavirus Infection
NCT02376478
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants who are found to be non-responders at week 18 will undergo standard of care ablation.
Participants who are found to have anal HSIL at weeks 30 or 42 will be followed according to standard of care procedures.
Primary Objective: To evaluate the complete and partial histopathologic response to four 5-day cycles of artesunate ointment in adult patients with biopsy-proven HPV-associated intra-anal HSIL (18 weeks).
Secondary Objectives:
Efficacy:
To evaluate the viral clearance after four 5-day cycles of artesunate ointment To evaluate complete and partial intra-anal response To evaluate complete and partial peri-anal response To evaluate persistence of response throughout the study window
Safety:
To evaluate the safety of artesunate ointment for the treatment of intra-anal HSIL.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Artesunate
Artesunate ointment
Four 5-day cycles of artesunate ointment given at weeks 0, 2, 4, 6
Placebo ointment
Placebo
Four 5-day cycles of placebo ointment given at weeks 0, 2, 4, 6
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Artesunate ointment
Four 5-day cycles of artesunate ointment given at weeks 0, 2, 4, 6
Placebo
Four 5-day cycles of placebo ointment given at weeks 0, 2, 4, 6
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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:
1. Serum alanine transaminase (SGPT/ALT) \< 5 x upper limit of normal (ULN)
2. Serum aspartate transaminase (SGOT/AST) \< 5 x ULN
3. Serum Bilirubin (total) \< 2.5 x ULN
4. Serum Creatinine ≤ 1.5 x ULN
* Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.
* Weight ≥ 50kg
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Laser Surgery Care, LLC
UNKNOWN
Anal Dysplasia Clinic MidWest
UNKNOWN
Frantz Viral Therapeutics, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anal Dysplasia Clinic MidWest
Chicago, Illinois, United States
Laser Surgery Care
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Emily Miller
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ART-AIN IIB-2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.