StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS) Symptoms
ConditionVulvar Lichen Sclerosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAndrew T. Goldstein, MD
About this trial
This study is designed to evaluate the efficacy and safety of StrataMGT for the management of vulvar lichen sclerosus symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
StrataMGT
DrugStrataMGT® 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
DrugThe placebo is a sterile, transparent, water-soluble lubricating jelly that is not silicone-based. It will be applied topically to the vulvar skin.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Investigational productActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
throughout the study, averaging 3.5 monthsSecondary outcomes
1
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.
Time frame
throughout the study, averaging 3.5 months2
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.
Time frame
throughout the study, averaging 3.5 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Andrew T. Goldstein, MD
Lead sponsor
Center for Vulvovaginal Disorders
Sponsor institution
Stratpharma AG
Collaborator
Source ClinicalTrials.gov