Vulvar DiseasesPhase 2ART-VIN IIBNCT06075264
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
A Phase 2 study testing Artesunate ointment in people with Vulvar Diseases and HPV Infection, run by Frantz Viral Therapeutics, LLC at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Diseases, HPV Infection, Vulvar HSIL
- What is being tested?
- Artesunate ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Dec 2023to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmad Bayat, MD contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
Donna White, 216-445-8090, whited11@ccf.org
Megan Park, 216-445-8090, parkm2@ccf.org
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Donna White, 216-445-8090, whited11@ccf.org
Megan Park, 216-445-8090, parkm2@ccf.org
- Recruiting
Florida Gynecologic Oncology
Fort Myers, Florida, 33905
Edward C. Grendys, MD FACOG, FACS, 239-334-6626, Edward.Grendys@usa.genesiscare.com
- Recruiting
Ascension St. Vincent
Indianapolis, Indiana, 46260
Sarah Goodrich, MD, inindgynoncresearch@ascension.org
Sarah Goodrich, MD
- Recruiting
Hillcrest Hospital
Mayfield Heights, Ohio, 44124
Donna White, 216-445-8090, whited11@ccf.org
Megan Park, 216-445-8090, parkm2@ccf.org
About this study
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)
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).
Read the detailed description
Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of vulvar HSIL. Both groups receive four 5-day cycles of topical ointment, at weeks 0, 2, 4, and 6. Dosing visits may be done in person or as telehealth (ointment may be shipped directly to the patient). Participants are followed closely with vulvar examinations or colposcopies at weeks 8, 18, 6-months and 12-months.
- Conditions
- Vulvar Diseases, HPV Infection, Vulvar HSIL, Pre-Cancerous Dysplasia, HPV Disease, VIN, Usual Type
- Being tested
- Artesunate ointment, Placebo ointment
- Keywords
- topical treatment, ointment, non-surgical, vulvar cancer prevention, high-risk HPV, human papillomavirus, HPV, vulvar HSIL, High grade lesions
- Medical subject headings
- Vulvar Diseases, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate ointmentDrug
Also called Artesunic acid, Dihydroartemisinin (DHA), Artemisinin
topical ointment, as a non-surgical treatment
Placebo ointmentDrug
Also called Placebo to artesunate ointment
topical placebo ointment
| Study group | Role | What they receive |
|---|---|---|
| Artesunate ointment | Active comparator | Artesunate formulated as topical ointment, 40% Four 5-day cycles of artesunate ointment every 2 weeks Receives: Drug: Artesunate ointment |
| Placebo ointment | Placebo comparator | Placebo ointment Four 5-day cycles of placebo ointment every 2 weeks Receives: Drug: Placebo ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with complete histologic response
Number of participants who have complete histologic response following topical artesunate ointment
Measured: 18 weeks
Secondary outcomes (4)
Number of participants who have achieved viral clearance
Number of participants who achieve clearance of HPV genotypes present at screening. These genotypes become undetectable over the study window.
Measured: Week 18
Number of participants who show partial response
Number of participants with documented partial response following topical artesunate
Measured: Week 18
Number of participants who have durable response
Number of participants with documented complete response who do not have recurrence of their vulvar HSIL over the study window
Measured: Week 18
Incidence of Treatment-Emergent Adverse Events (TEAE)
Number of participants who report artesunate-related serious adverse events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start6 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frantz Viral Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075264
- Sponsor's protocol ID
- ART-VIN IIB
- Other IDs
- 23-889
- Acronym
- ART-VIN IIB
- Status last verified
- Aug 2025
- First submitted
- 4 Oct 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06075264
- Acronym / sponsor ID
- ART-VIN IIB / ART-VIN IIB
- Conditions
- Vulvar Diseases, HPV Infection, Vulvar HSIL, Pre-Cancerous Dysplasia, HPV Disease, VIN, Usual Type
- Keywords
- topical treatment, ointment, non-surgical, vulvar cancer prevention, high-risk HPV, human papillomavirus, HPV, vulvar HSIL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Frantz Viral Therapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo ointment for the treatment of vulvar HSIL. Both groups receive four 5-day cycles of topical ointment, at weeks 0, 2, 4, and 6. Dosing visits may be done in person or as telehealth (ointment may be shipped directly to the patient). Participants are followed closely with vulvar examinations or colposcopies at weeks 8, 18, 6-months and 12-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled randomized trial
| Arm | Type | Receives |
|---|---|---|
| Artesunate ointment | Active comparator | Drug: Artesunate ointmentArtesunate formulated as topical ointment, 40% Four 5-day cycles of artesunate ointment every 2 weeks |
| Placebo ointment | Placebo comparator | Drug: Placebo ointmentPlacebo ointment Four 5-day cycles of placebo ointment every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artesunate ointmentAlso: Artesunic acid, Dihydroartemisinin (DHA), Artemisinintopical ointment, as a non-surgical treatment | Drug | Artesunate ointment |
| Placebo ointmentAlso: Placebo to artesunate ointmenttopical placebo ointment | Drug | Placebo ointment |
Primary outcome
Number of participants with complete histologic response
Time frame: 18 weeks
Number of participants who have complete histologic response following topical artesunate ointment
4 secondary outcomes
Number of participants who have achieved viral clearance
Time frame: Week 18
Number of participants who show partial response
Time frame: Week 18
Number of participants who have durable response
Time frame: Week 18
Incidence of Treatment-Emergent Adverse Events (TEAE)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmad Bayat, MD contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Artesunate ointment in people with Vulvar Diseases and HPV Infection, run by Frantz Viral Therapeutics, LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mihaela Plesa (440-255-1155, fvtinfo@frantzgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with complete histologic response (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.