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New treatment option for Vulvar Diseases
Official title Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
ClinicalTrials.gov ID: NCT06075264
What this study is testing
What is Artesunate ointment?
Artesunate ointment is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for vulvar diseases.
Also referred to as Artesunic acid, Dihydroartemisinin (DHA).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- Positive HPV test at study entry (any genotype).
You likely can't join 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...
- Currently receiving systemic chemotherapy or radiation therapy for another cancer.
See the full eligibility criteria
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Fort Myers, Florida, United States
- Indianapolis, Indiana, United States
- Cleveland, Ohio, United States
- Mayfield Heights, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Myers, Florida, United States; Indianapolis, Indiana, United States; Cleveland, Ohio, United States; Mayfield Heights, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.