Vulvar DysplasiaPhase 1ART-VINNCT03792516
Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3)
A Phase 1 study testing artesunate ointment 40% in people with Vulvar Dysplasia and HPV-Related Vulvar Intraepithelial Neoplasia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 4 sites in United States.
Trial summary
This is a Phase I, proof-of-concept treatment study to evaluate the safety, tolerability and feasibility of topical artesunate ointment to treat high grade vulvar intraepithelial neoplasia (HSIL VIN2/3). Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvar Dysplasia, HPV-Related Vulvar Intraepithelial Neoplasia, Preinvasive Vulvar Disease
- What is being tested?
- artesunate ointment 40%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Apr 2019to 3 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Colposcopically-directed biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease.
- Females of childbearing potential: negative urine pregnancy test
- Ability to provide informed consent
- Ability to collaborate with planned follow-up (transportation, compliance history, etc.)
- Use of contraception through the study exit visit (week 28)
Who cannot join
- Concomitant use of any topical immune modulating agents e.g. imiquimod, Aldara ®
- Cluster of differentiation 4 (CD4) count < 200 at the time of screening for eligibility.
- Unable to provide informed consent
- Currently receiving systemic chemotherapy or radiation therapy for another cancer.
- Pregnant females
- Concurrent dermatological disorders involving the vulva (i.e., herpes, ulceration secondary to Crohn's disease) or vulvar dermatosis (i.e., lichen planus, lichen sclerosus, or lichen simplex chronicus);
- Women weighing less than 50 kg
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21205
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
Cleveland Clinic Foundation - Main Campus
Cleveland, Ohio, 44195
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, 44124
About this study
Official title: A Phase I Proof-of-Concept Study of Artesunate Ointment for the Treatment of Patients With High-Grade Vulvar Intraepithelial Neoplasia (HSIL VIN 2/3)
This is a Phase I, proof-of-concept treatment study to evaluate the safety, tolerability and feasibility of topical artesunate ointment to treat high grade vulvar intraepithelial neoplasia (HSIL VIN2/3).
Read the detailed description
Phase I open-label dose escalation study of topical artesunate, formulated as ointment, in the treatment of adult females with biopsy-confirmed HSIL VIN2/3. Fifteen (15) subjects will undergo up to a total of three cycles of topical artesunate. The first cycle will be initiated on Day 0, the second at Week 2, and the third and final cycle at week 4.
Primary Objective:
To evaluate the safety and tolerability of artesunate ointment applied topically on VIN2/3 lesions
To measure the effect of artesunate ointment on histologic regression of HSIL/VIN2/3 to VIN1 or less, confirmed by a colposcopically-directed biopsy, at study week 15.
- Conditions
- Vulvar Dysplasia, HPV-Related Vulvar Intraepithelial Neoplasia, Preinvasive Vulvar Disease, Vulva Intraepithelial Neoplasia, Vulvar Diseases
- Being tested
- artesunate ointment 40%
- Keywords
- artesunate, pre-invasive disease, treatment, alternative, non-surgical, cancer prevention
- Medical subject headings
- Vulvar Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artesunate ointment 40%Drug
artesunate formulated as an ointment to be applied topically to the vulva
| Study group | Role | What they receive |
|---|---|---|
| Artesunate ointment 40%, 1 cycle | Experimental | Patients enrolled in this treatment group will receive one 5-day cycle of artesunate ointment applied topically to the vulva at week 0. Receives: Drug: artesunate ointment 40% |
| Artesunate ointment 40%, 2 cycles | Experimental | Patients enrolled in this treatment group will receive two 5-day cycles of artesunate ointment applied topically to the vulva at weeks 0 and 2. Receives: Drug: artesunate ointment 40% |
| Artesunate ointment 40%, 3 cycles | Experimental | Patients enrolled in this treatment group will receive three 5-day cycles of artesunate ointment applied topically to the vulva at weeks 0, 2, and 4. Receives: Drug: artesunate ointment 40% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of artesunate ointment applied topically on VIN2/3 lesions as assessed by number of participants experiencing serious adverse events or dose-limiting toxicities
Number of participants with study-related serious adverse events or dose-limiting toxicities assessed using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) criteria
Measured: 15 weeks
Secondary outcomes (1)
Effect of artesunate ointment as assessed by number of participants with regression to VIN1 or less at week 15
Number of participants with histologic regression of HSIL/VIN2/3 to VIN1 or less on colposcopically-directed biopsy, at study week 15 after receiving artesunate ointment therapy.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start17 Apr 2019
- Primary completion31 Aug 2022
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar DysplasiaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Frantz Viral Therapeutics, LLC
- Responsible party
- Sponsor
- Investigators
- Cornelia L Trimble, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792516
- Sponsor's protocol ID
- J18169
- Other IDs
- IRB00196703, IRB 19 1353
- Acronym
- ART-VIN
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2019
- Last updated
- 4 Dec 2024
- 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Proof-of-Concept Study of Artesunate Ointment for the Treatment of Patients With High-Grade Vulvar Intraepithelial Neoplasia (HSIL VIN 2/3)
- ClinicalTrials.gov ID
- NCT03792516
- Acronym / sponsor ID
- ART-VIN / J18169
- Conditions
- Vulvar Dysplasia, HPV-Related Vulvar Intraepithelial Neoplasia, Preinvasive Vulvar Disease, Vulva Intraepithelial Neoplasia, Vulvar Diseases
- Keywords
- artesunate, pre-invasive disease, treatment, alternative, non-surgical, cancer prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Frantz Viral Therapeutics, LLC
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 3 Jan 2019 (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 I, proof-of-concept treatment study to evaluate the safety, tolerability and feasibility of topical artesunate ointment to treat high grade vulvar intraepithelial neoplasia (HSIL VIN2/3).
Detailed description
Phase I open-label dose escalation study of topical artesunate, formulated as ointment, in the treatment of adult females with biopsy-confirmed HSIL VIN2/3. Fifteen (15) subjects will undergo up to a total of three cycles of topical artesunate. The first cycle will be initiated on Day 0, the second at Week 2, and the third and final cycle at week 4.
Primary Objective:
To evaluate the safety and tolerability of artesunate ointment applied topically on VIN2/3 lesions
To measure the effect of artesunate ointment on histologic regression of HSIL/VIN2/3 to VIN1 or less, confirmed by a colposcopically-directed biopsy, at study week 15.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Artesunate ointment 40%, 1 cycle | Experimental | Drug: artesunate ointment 40%Patients enrolled in this treatment group will receive one 5-day cycle of artesunate ointment applied topically to the vulva at week 0. |
| Artesunate ointment 40%, 2 cycles | Experimental | Drug: artesunate ointment 40%Patients enrolled in this treatment group will receive two 5-day cycles of artesunate ointment applied topically to the vulva at weeks 0 and 2. |
| Artesunate ointment 40%, 3 cycles | Experimental | Drug: artesunate ointment 40%Patients enrolled in this treatment group will receive three 5-day cycles of artesunate ointment applied topically to the vulva at weeks 0, 2, and 4. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Colposcopically-directed biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease.
- Females of childbearing potential: negative urine pregnancy test
- Ability to provide informed consent
- Ability to collaborate with planned follow-up (transportation, compliance history, etc.)
- Use of contraception through the study exit visit (week 28)
Key exclusion criteria (7 listed)
- Concomitant use of any topical immune modulating agents e.g. imiquimod, Aldara ®
- Cluster of differentiation 4 (CD4) count < 200 at the time of screening for eligibility.
- Unable to provide informed consent
- Currently receiving systemic chemotherapy or radiation therapy for another cancer.
- Pregnant females
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 ointment 40%artesunate formulated as an ointment to be applied topically to the vulva | Drug | Artesunate ointment 40%, 1 cycle, Artesunate ointment 40%, 2 cycles, Artesunate ointment 40%, 3 cycles |
Primary outcome
Safety and tolerability of artesunate ointment applied topically on VIN2/3 lesions as assessed by number of participants experiencing serious adverse events or dose-limiting toxicities
Time frame: 15 weeks
Number of participants with study-related serious adverse events or dose-limiting toxicities assessed using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) criteria
1 secondary outcome
Effect of artesunate ointment as assessed by number of participants with regression to VIN1 or less at week 15
Time frame: 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Vulvar Dysplasia
RecruitingObservational study
Evaluation of a Point-of-Care, AI-Powered Spectroscopy Device for Triage of Suspicious Vulvar Lesions: A Pilot Study
Vulvar Intraepithelial Neoplasia, HPV-Independent, Vulvar Squamous Cell Carcinoma
Not yet recruiting
Needlefree Lidocaine Application for Vulvar Biopsies
Vulvar Cancers, Vulva Neoplasm
RecruitingObservational study
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
Cancer Risk, Cancer Predisposition Syndrome
RecruitingPhase 2
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
Vulvar Diseases, HPV Infection
Recruiting
Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
Vulvar Cancer, Cervical Cancer
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. This study is not recruiting at the moment.
Cornelia L Trimble, MD principal investigator
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing artesunate ointment 40% in people with Vulvar Dysplasia and HPV-Related Vulvar Intraepithelial Neoplasia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 4 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of artesunate ointment applied topically on VIN2/3 lesions as assessed by number of participants experiencing serious adverse events or dose-limiting toxicities (time frame: 15 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 4 Dec 2024.