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

Study Overview
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Brief Summary
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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).

Detailed Description
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In this study, subjects who fulfil all inclusion and exclusion criteria are enrolled. Eligible subjects will be randomized in a 1:1 ratio to MC2-25 cream or MC2-25 vehicle, respectively. The subjects will apply the assigned investigational medicinal product (IMP) daily for 12 weeks.

Official Title
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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)

Conditions
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Vulvar Lichen Sclerosus

Intervention / Treatment
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* Drug: MC2-25 cream
* Drug: MC2-25 vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel-group, Randomized, Double-blind
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MC2-25 cream<br>MC2-25 cream will be applied daily for 12 weeks | Drug: MC2-25 cream<br>* Topical application<br>|
| Experimental: MC2-25-vehicle<br>MC2-25 vehicle will be applied daily for 12 weeks | Drug: MC2-25 vehicle<br>* Topical application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in weekly mean Worst Itch Numeric Rating Score (WI-NRS) | Mean change in weekly Worst Itch Numeric Rating score WI-NRS (as measured on a 11-point numeric rating scale from 0 - 10, where 0 represents no itch and 10 represents worst imaginal itch), calculated as the average of weekly means WI-NRS values from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle. | 12 weeks |