Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)

NCT06075264 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: ART-VIN IIB23-889
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 5

Brief Summary

This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).

Conditions

Vulvar Diseases; HPV Infection; Vulvar HSIL; Pre-Cancerous Dysplasia; HPV Disease; VIN, Usual Type; VIN 2 of Usual Type; VIN 3 of Usual Type; Vin II; Vin III; VIN Grade 2; VIN Grade 3; High Grade Intraepithelial Neoplasia

Keywords

topical treatment; ointment; non-surgical; vulvar cancer prevention; high-risk HPV; human papillomavirus; HPV; vulvar HSIL; High grade lesions

Outcome Measures

Primary Outcomes (1)

• Number of participants with complete histologic response

  Number of participants who have complete histologic response following topical artesunate ointment

  18 weeks

Secondary Outcomes (4)

• Number of participants who have achieved viral clearance

  Week 18

• Number of participants who show partial response

  Week 18

• Number of participants who have durable response

  Week 18

• Incidence of Treatment-Emergent Adverse Events (TEAE)

  8 weeks

Study Arms (2)

Artesunate ointment

ACTIVE COMPARATOR

Artesunate formulated as topical ointment, 40% Four 5-day cycles of artesunate ointment every 2 weeks

Drug: Artesunate ointment

Placebo ointment

PLACEBO COMPARATOR

Placebo ointment Four 5-day cycles of placebo ointment every 2 weeks

Drug: Placebo ointment

Interventions

Artesunate ointment DRUG

topical ointment, as a non-surgical treatment

Also known as: Artesunic acid, Dihydroartemisinin (DHA), Artemisinin

Artesunate ointment

Placebo ointment DRUG

topical placebo ointment

Also known as: Placebo to artesunate ointment

Placebo ointment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is only for biological females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women age ≥ 18 years
• Capable of informed consent
• Able to collaborate with planned follow-up (transportation, compliance history, etc)
• Biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease. A biopsy diagnosis of vulvar high-grade squamous intraepithelial lesion within the previous 3 months which was not excised or otherwise treated may be accepted for study entry.
• Positive HPV test at study entry (any genotype).
• Women of childbearing potential agree to use birth control during the dosing phase (through week 8).
• 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
• Weight ≥ 50kg

You may not qualify if:

• Pregnant and nursing women
• Concurrent anal, vulvar, or cervical cancer
• HIV-positive participants with a CD4 count \< 200
• Participants infected with HIV-1 if not on a stable, suppressive antiretroviral therapy (ART) regimen.
• Unwillingness to undergo an excisional procedure at week 18 to either remove HSIL lesions, or to document histologic regression at a site where HSIL was present at study entry.
• Currently receiving systemic chemotherapy or radiation therapy for another cancer.
• Concomitant use of Efavirenz for HIV antiretroviral treatment
• Concomitant use of strong UGT inhibitors
• Concomitant use of imiquimod, cidofovir, or 5-fluorouracil (5-FU) for the duration of the study
• Concurrent dermatological conditions affecting the vulva (e.g., herpetic lesion, Crohn's disease, hidradenitis suppurativa) or vulvar dermatoses (e.g., lichen sclerosis or planus, atopic dermatitis, genital atrophy).
• Concurrent treatment with systemic corticosteroids

Sponsors & Collaborators

• Frantz Viral Therapeutics, LLC: lead
• The Cleveland Clinic: collaborator

Study Sites (5)

Florida Gynecologic Oncology

Fort Myers, Florida, 33905, United States

RECRUITING

Ascension St. Vincent

Indianapolis, Indiana, 46260, United States

RECRUITING

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, 44111, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

RECRUITING

MeSH Terms

Conditions

Vulvar Diseases; Papillomavirus Infections

Interventions

artesunic acid; artenimol; artemisinin

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mihaela Plesa

CONTACT

440-255-1155; fvtinfo@frantzgroup.com

Ahmad Bayat, MD

CONTACT

301-956-2523

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind, placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled randomized trial

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: December 6, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)