Vulvar Lichen SclerosusPhase 1LSNCT06662942
StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS) Symptoms
A Phase 1 study testing StrataMGT in people with Vulvar Lichen Sclerosus, run by Andrew T. Goldstein, MD at 3 sites in United States.
Trial summary
This study is designed to evaluate the efficacy and safety of StrataMGT for the management of vulvar lichen sclerosus symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Lichen Sclerosus
- What is being tested?
- StrataMGT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Oct 2024to 16 Oct 2025
- Phase
- Phase 1
- 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
- Female, 18 years or older.
- With a diagnosis of biopsy proven vulvar lichen sclerosus.
- Signed written informed consent.
- Willingness and ability to comply with the study requirements.
- Subject must have a score of 10 or greater in the VQLI at screening.
- Must be on a stable regimen of topical corticosteroids or topical calcineurin inhibitor for at least 2 months prior to the screening visit.
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- Women currently on a stable regimen of intravaginal estrogen therapy for at least 2 months may remain on the estrogen therapy throughout the study.
- Women currently using topical estrogen therapy on the vulva must stop two weeks prior to enrolling in the study.
- Women must have a culture negative for candidiasis or bacterial vaginosis at screening.
Who cannot join
- Who are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease.
- Who suffer from a topical or systemic infections (bacterial, viral or fungal) at the time of screening. Subjects who screen positive for either candidiasis or bacterial vaginosis at the screening visit may be treated and retested and may participate if the confirmatory test after treatment is negative. Any vulvovaginal infections during their participation in the study will be considered an adverse event. The subject will then stop the study IP and will be treated for the infection and may resume use of the IP 3 days after the last dose of medication for the infection. They will be discontinued from the study if they have two infections during the study.
- Who have been diagnosed with lichen planus, psoriasis, intraepithelial neoplasia, or carcinoma of the vulva.
- Who had received an investigational drug within four weeks prior to the study or who intend to use other investigational drugs during the course of this study.
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
- Who have a history of substance abuse or any factor, which limits the subject's ability to cooperate with the study procedures.
- Who are uncooperative, known to miss appointments (according to subjects' records) and are unlikely to follow medical instructions or are not willing to attend regularly scheduled visits.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sylvia Lorenzini contact
United States3 sites, 3 recruiting
- Recruiting
Centers for Vulvovaginal Disorders, NY
New York, New York, 10036
Andrew Goldstein, MD, 4102790209, obstetrics@yahoo.com
Analea Beckman, analea@vulvodynia.com
- Recruiting
Centers for Vulvovaginal Disorders, FL
Tampa, Florida, 33609
Jill Krapf, MD, (813) 358-7634, researchjkmd@gmail.com
Gracie Nootz, 813-358-7634, gracie@jillkrapfmd.com
- Recruiting
Centers for Vulvovaginal Disorders, DC
Washington D.C., District of Columbia, 20037
Chailee Moss, MD, 202-887-0568, chaileemossmd@vulvodynia.com
Sylvia Lorenzini, 2028870568 ext. 107, sylvia@vulvodynia.com
About this study
Official title: A Double Blind Placebo-controlled Trial of StrataMGT for the Management of Vulvar Lichen Sclerosus Symptoms.
This study is designed to evaluate the efficacy and safety of StrataMGT for the management of vulvar lichen sclerosus symptoms.
Read the detailed description
This will be a randomized double-blind placebo-controlled trial to evaluate the efficacy and safety of StrataMGT for the management of the symptoms of vulvar lichen sclerosus. Up to 100 patients with a diagnosis of biopsy proven vulvar lichen sclerosus will be recruited from two centers. This study will consist of a two-week screening period and a 12-week treatment period. At the beginning of the screening period, a vulvoscopy will be performed at the screening visit and after the 12-week treatment period to rule out vulvar intrepithelial neoplasia (VIN) or carcinoma. All eligible patients will be randomized to receive either placebo gel or treatments with the investigation product, StrataMGT TM 1:1 ratio.
The primary efficacy endpoint will be change in score on the Vulvar Quality of Life Index 11 (VQLI).
Secondary efficacy endpoints will be the Skindex 29, and the Clinical Lichen Sclerosus Scoring Scale (CLISSCO).
All adverse events will be recorded, including serious adverse events. A physical examination will be performed at each visit.
- Conditions
- Vulvar Lichen Sclerosus
- Being tested
- StrataMGT, Placebo
- Keywords
- StrataMGT
- Medical subject headings
- Vulvar Lichen Sclerosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrataMGTDrug
StrataMGT® is a semi-permeable, non-resorbable and self-drying gel. StrataMGT® contains no steroids, hormones, alcohol, parabens or fragrances. StrataMGT® gel is bacteriostatic, inert, and is manufactured in compliance with good manufacturing practices (GMPs), 21CFR210 and 211.
PlaceboDrug
The placebo is a sterile, transparent, water-soluble lubricating jelly that is not silicone-based. It will be applied topically to the vulvar skin.
| Study group | Role | What they receive |
|---|---|---|
| Investigational product | Active comparator | StrataMGT® is a semi-permeable, non-resorbable and self-drying gel. StrataMGT® contains no steroids, hormones, alcohol, parabens or fragrances. StrataMGT® gel is bacteriostatic, inert, and is manufactured in compliance with good manufacturing practices (GMPs), 21CFR210 and 211. Receives: Drug: StrataMGT |
| Placebo | Placebo comparator | This arm will be a sterile, transparent, water-soluble lubricating jelly that is not silicone-based. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vulvar Quality of Life Index 11 (VQLI)
The VQLI is used to "assess symptomatic, psychosexual and physical aspects of vulvar disease" [1] using the following scale: Very Much, A Lot, A Little, and Not At All. The questionnaire consists of 15 questions.
Measured: throughout the study, averaging 3.5 months
Secondary outcomes (2)
Skindex 29
The Skindex 29 is a subjective survey used to assess which skin conditions have bothered a patient the most on the following scale: All the time, often, sometimes, rarely, and never. The survey consists of 30 questions.
Measured: throughout the study, averaging 3.5 months
Clinical Scoring System for Vulvar Lichen Sclerosus
The Clinical Scoring System for Vulvar Lichen Sclerosus is a subjective and objective survey filled out by the patient and provider. It is used to assess the patient's severity of subjective symptoms and the provider's interpretation of the severity of visible symptoms associated with vulvar LS.
Measured: throughout the study, averaging 3.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start16 Oct 2024
- Primary completion16 Oct 2025 (estimated)
- Study completion16 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar Lichen SclerosusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind, placebo-controlled clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrew T. Goldstein, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Stratpharma AG
- Responsible party
- Sponsor-investigator, Andrew T. Goldstein, MD, Center for Vulvovaginal Disorders
- Investigators
- Chailee Moss, MD, Study director, Centers for Vulvovaginal Disorders, DCJill Krapf, MD, Study director, Centers for Vulvovaginal Disorders, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662942
- Sponsor's protocol ID
- CVVD005
- Other IDs
- 24-02-237
- Acronym
- LS
- Status last verified
- Nov 2024
- First submitted
- 25 Oct 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Placebo-controlled Trial of StrataMGT for the Management of Vulvar Lichen Sclerosus Symptoms.
- ClinicalTrials.gov ID
- NCT06662942
- Acronym / sponsor ID
- LS / CVVD005
- Conditions
- Vulvar Lichen Sclerosus
- Keywords
- StrataMGT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Andrew T. Goldstein, MDUniversity, hospital or other
- Collaborators
- Stratpharma AG
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 16 Oct 2025 (estimated)
- Study completion
- 16 Oct 2025 (estimated)
- First posted
- 29 Oct 2024 (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 study is designed to evaluate the efficacy and safety of StrataMGT for the management of vulvar lichen sclerosus symptoms.
Detailed description
This will be a randomized double-blind placebo-controlled trial to evaluate the efficacy and safety of StrataMGT for the management of the symptoms of vulvar lichen sclerosus. Up to 100 patients with a diagnosis of biopsy proven vulvar lichen sclerosus will be recruited from two centers. This study will consist of a two-week screening period and a 12-week treatment period. At the beginning of the screening period, a vulvoscopy will be performed at the screening visit and after the 12-week treatment period to rule out vulvar intrepithelial neoplasia (VIN) or carcinoma. All eligible patients will be randomized to receive either placebo gel or treatments with the investigation product, StrataMGT TM 1:1 ratio.
The primary efficacy endpoint will be change in score on the Vulvar Quality of Life Index 11 (VQLI).
Secondary efficacy endpoints will be the Skindex 29, and the Clinical Lichen Sclerosus Scoring Scale (CLISSCO).
All adverse events will be recorded, including serious adverse events. A physical examination will be performed at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double-blind, placebo-controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Investigational product | Active comparator | Drug: StrataMGTStrataMGT® is a semi-permeable, non-resorbable and self-drying gel. StrataMGT® contains no steroids, hormones, alcohol, parabens or fragrances. StrataMGT® gel is bacteriostatic, inert, and is manufactured in compliance with good manufacturing practices (GMPs), 21CFR210 and 211. |
| Placebo | Placebo comparator | Drug: PlaceboThis arm will be a sterile, transparent, water-soluble lubricating jelly that is not silicone-based. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female, 18 years or older.
- With a diagnosis of biopsy proven vulvar lichen sclerosus.
- Signed written informed consent.
- Willingness and ability to comply with the study requirements.
- Subject must have a score of 10 or greater in the VQLI at screening.
Key exclusion criteria (7 listed)
- Who are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease.
- Who suffer from a topical or systemic infections (bacterial, viral or fungal) at the time of screening. Subjects who screen positive for either candidiasis or bacterial vaginosis at the screening visit may be treated and retested and may participate if the confirmatory test after treatment is negative. Any vulvovaginal infections during their participation in the study will be considered an adverse event. The subject will then stop the study IP and will be treated for the infection and may resume use of the IP 3 days after the last dose of medication for the infection. They will be discontinued from the study if they have two infections during the study.
- Who have been diagnosed with lichen planus, psoriasis, intraepithelial neoplasia, or carcinoma of the vulva.
- Who had received an investigational drug within four weeks prior to the study or who intend to use other investigational drugs during the course of this study.
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
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 |
|---|---|---|
| StrataMGTStrataMGT® is a semi-permeable, non-resorbable and self-drying gel. StrataMGT® contains no steroids, hormones, alcohol, parabens or fragrances. StrataMGT® gel is bacteriostatic, inert, and is manufactured in compliance with good manufacturing practices (GMPs), 21CFR210 and 211. | Drug | Investigational product |
| PlaceboThe placebo is a sterile, transparent, water-soluble lubricating jelly that is not silicone-based. It will be applied topically to the vulvar skin. | Drug | Placebo |
Primary outcome
Vulvar Quality of Life Index 11 (VQLI)
Time frame: throughout the study, averaging 3.5 months
The VQLI is used to "assess symptomatic, psychosexual and physical aspects of vulvar disease" [1] using the following scale: Very Much, A Lot, A Little, and Not At All. The questionnaire consists of 15 questions.
2 secondary outcomes
Skindex 29
Time frame: throughout the study, averaging 3.5 months
Clinical Scoring System for Vulvar Lichen Sclerosus
Time frame: throughout the study, averaging 3.5 months
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 8 Nov 2024.
- 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.
Sylvia Lorenzini contact
Chailee Moss, MD study director
Centers for Vulvovaginal Disorders, DC
Jill Krapf, MD study director
Centers for Vulvovaginal Disorders, FL
3 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 StrataMGT in people with Vulvar Lichen Sclerosus, run by Andrew T. Goldstein, MD at 3 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 9 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: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
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 Andrew T Goldstein, MD (4102790209, obstetrics@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vulvar Quality of Life Index 11 (VQLI) (time frame: throughout the study, averaging 3.5 months). 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 8 Nov 2024.