StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS) Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: StrataMGT, Placebo.
- Who it may be relevant to
- Registry conditions: Vulvar Lichen Sclerosus. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Double Blind Placebo-controlled Trial of StrataMGT for the Management of Vulvar Lichen Sclerosus Symptoms.
Overview
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.
Interventions
- Drug StrataMGT
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. - Drug Placebo
The placebo is a sterile, transparent, water-soluble lubricating jelly that is not silicone-based. It will be applied topically to the vulvar skin.
Primary outcome measures
- Vulvar Quality of Life Index 11 (VQLI) [Time frame: throughout the study, averaging 3.5 months]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Centers for Vulvovaginal Disorders, DC — Washington D.C.
- Centers for Vulvovaginal Disorders, FL — Tampa
- Centers for Vulvovaginal Disorders, NY — New York
Identifiers
NCT: NCT06662942 · CVVD005 · 24-02-237