RECRUITING

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

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Conditions

Vulvar DiseasesHPV InfectionVulvar HSILPre-Cancerous DysplasiaHPV DiseaseVIN, Usual TypeVIN 2 of Usual TypeVIN 3 of Usual TypeVin IIVin IIIVIN Grade 2VIN Grade 3High Grade Intraepithelial Neoplasiatopical treatmentointmentnon-surgicalvulvar cancer preventionhigh-risk HPVhuman papillomavirusHPVHigh grade lesions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase II Double-blind, Placebo-controlled, Randomized Trial of Topical Artesunate Ointment for the Treatment of Patients With Vulvar High-grade Squamous Intraepithelial Lesions (Vulvar HSIL)

Quick Facts

Study Start:2023-12-06
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06075264

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult women age ≥ 18 years
  2. * Capable of informed consent
  3. * Able to collaborate with planned follow-up (transportation, compliance history, etc)
  4. * 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.
  5. * Positive HPV test at study entry (any genotype).
  6. * Women of childbearing potential agree to use birth control during the dosing phase (through week 8).
  7. * Laboratory values at Screening of:
  8. * Serum alanine transaminase (SGPT/ALT) \< 5 x upper limit of normal (ULN)
  9. * Serum aspartate transaminase (SGOT/AST) \< 5 x ULN
  10. * Serum Bilirubin (total) \< 2.5 x ULN
  11. * Serum Creatinine ≤ 1.5 x ULN
  12. * Weight ≥ 50kg
  1. * Pregnant and nursing women
  2. * Concurrent anal, vulvar, or cervical cancer
  3. * HIV-positive participants with a CD4 count \< 200
  4. * Participants infected with HIV-1 if not on a stable, suppressive antiretroviral therapy (ART) regimen.
  5. * 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.
  6. * Currently receiving systemic chemotherapy or radiation therapy for another cancer.
  7. * Concomitant use of Efavirenz for HIV antiretroviral treatment
  8. * Concomitant use of strong UGT inhibitors
  9. * Concomitant use of imiquimod, cidofovir, or 5-fluorouracil (5-FU) for the duration of the study
  10. * 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).
  11. * Concurrent treatment with systemic corticosteroids

Contacts and Locations

Study Contact

Mihaela Plesa
CONTACT
440-255-1155
fvtinfo@frantzgroup.com
Ahmad Bayat, MD
CONTACT
301-956-2523

Study Locations (Sites)

Florida Gynecologic Oncology
Fort Myers, Florida, 33905
United States
Ascension St. Vincent
Indianapolis, Indiana, 46260
United States
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Hillcrest Hospital
Mayfield Heights, Ohio, 44124
United States

Collaborators and Investigators

Sponsor: Frantz Viral Therapeutics, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-06
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-12-06
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • 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