A Parallel Group (2-arm), Randomised, Double-blind, 12-week Trial to Explore the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Women Diagnosed With Vulvar Lichen Sclerosus (VLS)

MC2-25-C3

The purpose of this study is to explore the efficacy and safety of MC2-25 cream and MC2-25 vehicle in women with vulvar lichen schelosus (VLS).

2023-10-11

2024-05-27

2024-06-10

Recruiting

Early phase I

40

Inclusion Criteria: * Women, of any race or ethnicity, who are ≥18 years of age at the time of screening. * Able to understand the trial and willing to comply with trial requirements. * Has provided written informed consent. * Clinical diagnosis of VLS. * Presence of at least one of the following signs of VLS: Hyperkeratosis and/or Sclerosis. * First symptoms of VLS noticed by the patient at least 6 months before baseline. * At least four WI-NRS scores available in the diary for calculation of the average WI-NRS at the baseline visit. * At least moderate itch defined as average WI-NRS ≥4 at the Baseline visit. * Women must be of either of non-childbearing potential or childbearing potential with a negativ urine pregnancy test at baseline. * Women of childbearing potential must agree to use a highly effective method of contraception. Exclusion Criteria: * Pregnant, breast feeding, or planning to become pregnant during the trial. * Any (other than VLS) ongoing localized or systemic disease involving the vulvar region. * Ongoing symptomatic Urinary Tract Infection. * Ongoing or prior diagnosis of any genitoanal malignancy or pre-malignancy. * Any kind of ongoing cancer prior to the Baseline visit. * Any chronic or acute systemic medical condition that, in the opinion of the investigator, may pose a risk to the safety of the patient or may interfere with the assessment of efficacy in this trial. * Known history of allergic reaction to any ingredients in MC2-25 cream or MC2-25 vehicle. * Start of a new or change of existing non-biologic systemic treatment, within 21 days prior to the Baseline visit. * Start of a new or change of existing biologic systemic treatment, within 3 months or 5 half-lives (whichever is longest) prior to the Baseline visit. * Start of a new or change of existing systemic or intravaginal treatment with estrogen containing products, within 21 days prior to the Baseline visit. * Start of new or change of menstrual care routines within 21 days prior to the Baseline visit. * Use of emollients on the vulvar region within 3 days prior to the Baseline visit. * Use of any topical treatment on the vulvar region, within 14 days prior to the Baseline visit. * Use of any light therapy on the vulvar region, within 28 days prior to the Baseline visit. * Received a non-marketed or blinded drug within 28 days or 5 half-lives (whichever is longer) prior to the Baseline visit. * If in the opinion of the investigator, the patient is unlikely to comply with the clinical trial protocol. * If previously randomized in this trial.

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2023-11-21