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

NCT06132919 | Completed Phase 2 Results

• 1 other identifier: MC2-25-C3
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Vulvar Lichen Sclerosus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

MC2-25 cream

EXPERIMENTAL

MC2-25 cream will be applied daily for 12 weeks

Drug: MC2-25 cream

MC2-25-vehicle

EXPERIMENTAL

MC2-25 vehicle will be applied daily for 12 weeks

Drug: MC2-25 vehicle

Interventions

MC2-25 cream DRUG

Topical application

MC2-25 cream

MC2-25 vehicle DRUG

Topical application

MC2-25-vehicle

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women diagnosed with vulvar lichen sclerosus (VLS) may enter the trial
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MC2 Therapeutics: lead

Study Sites (1)

MC2 Therapeutics study site

Kolding, Denmark

Location

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: MC2 Therapeutics

info@mc2therapeutics.com

+45 2018 1111

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel-group, Randomized, Double-blind

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: October 11, 2023
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)