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

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
Frantz Viral Therapeutics, LLC
Study ID
NCT06075264
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Artesunate ointment — DRUG
    topical ointment, as a non-surgical treatment
  • Placebo ointment — DRUG
    topical placebo ointment

Study Details

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).

Key Dates

Start date
Dec 6, 2023
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
27 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Artesunate ointment
    Artesunate formulated as topical ointment, 40% Four 5-day cycles of artesunate ointment every 2 weeks
  • Placebo Comparator: Placebo ointment
    Placebo ointment Four 5-day cycles of placebo ointment every 2 weeks

Primary Outcome Measure

Number of participants with complete histologic response [ Time Frame: 18 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Florida Gynecologic OncologyFort MyersFlorida33905
Edward C. Grendys, MD FACOG, FACS
[email protected]
239-334-6626
Ascension St. VincentIndianapolisIndiana46260
Sarah Goodrich, MD
[email protected]
Sarah Goodrich, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic Fairview HospitalClevelandOhio44111
Donna White
[email protected]
216-445-8090
Megan Park
[email protected]
216-445-8090
Chad Michener, MD (PRINCIPAL_INVESTIGATOR)
Mariam AlHilli, MD (SUB_INVESTIGATOR)
Steven Waggonner, MD (SUB_INVESTIGATOR)
Robert DeBernardo, MD (SUB_INVESTIGATOR)
Roberto Vargas, MD (SUB_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44195
Donna White
[email protected]
216-445-8090
Megan Park
[email protected]
216-445-8090
Chad Michener, MD (PRINCIPAL_INVESTIGATOR)
Lindsey Beffa, MD (SUB_INVESTIGATOR)
Steven Waggonner, MD (SUB_INVESTIGATOR)
Robert DeBernardo, MD (SUB_INVESTIGATOR)
Roberto Vargas, MD (SUB_INVESTIGATOR)
Mariam AlHilli, MD (SUB_INVESTIGATOR)
Johanna Kelley, MD (SUB_INVESTIGATOR)
Daniel Margul, MD (SUB_INVESTIGATOR)
Michelle Kuznicki, MD (SUB_INVESTIGATOR)
Hillcrest HospitalMayfield HeightsOhio44124
Donna White
[email protected]
216-445-8090
Megan Park
[email protected]
216-445-8090
Chad Michener, MD (PRINCIPAL_INVESTIGATOR)
Mariam AlHilli, MD (SUB_INVESTIGATOR)
Steven Waggonner, MD (SUB_INVESTIGATOR)
Robert DeBernardo, MD (SUB_INVESTIGATOR)
Roberto Vargas, MD (SUB_INVESTIGATOR)
Lindsey Beffa, MD (SUB_INVESTIGATOR)

Find similar trials in Fort Myers, FL

By research site
Florida Gynecologic Oncology· Fort Myers, FLAscension St. Vincent· Indianapolis, INCleveland Clinic Fairview Hospital· Cleveland, OHCleveland Clinic Foundation· Cleveland, OHHillcrest Hospital· Mayfield Heights, OH

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