Efficacy and Safety of MC2-25 Cream & Vehicle in Women With Vulvar Lichen Sclerosus (VLS)

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 …