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

NCT ID: NCT06132919

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-11
• Study Completion Date: 2024-11-08

Brief Summary

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

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.

Conditions

Vulvar Lichen Sclerosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MC2-25 cream

MC2-25 cream will be applied daily for 12 weeks

Group Type: EXPERIMENTAL

MC2-25 cream

Intervention Type: DRUG

Topical application

MC2-25-vehicle

MC2-25 vehicle will be applied daily for 12 weeks

Group Type: EXPERIMENTAL

MC2-25 vehicle

Intervention Type: DRUG

Topical application

Interventions

MC2-25 cream

Topical application

Intervention Type: DRUG

MC2-25 vehicle

Topical application

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MC2 Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MC2 Therapeutics study site

Kolding, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MC2-25-C3

Identifier Type: -

Identifier Source: org_study_id