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

Phase 2

Completed

• Conditions: Vulvar Lichen Sclerosus
• Interventions: Drug: MC2-25 cream; Drug: MC2-25 vehicle

• Registration Number: NCT06132919
• Lead Sponsor: MC2 Therapeutics

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.

Study Timeline

• Study Start: 2023-10-11
• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-10
• Study First Posted: 2023-11-15
• Status Verified: 2024-11
• Primary Completion: 2024-11-08
• Study Completion: 2024-11-08
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MC2-25 cream	MC2-25 cream	MC2-25 cream will be applied daily for 12 weeks
MC2-25-vehicle	MC2-25 vehicle	MC2-25 vehicle will be applied daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Mean change in weekly mean Worst Itch Numeric Rating Score (WI-NRS)	12 weeks	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.

Trial Locations

Locations (1)

MC2 Therapeutics study site; 🇩🇰 Kolding, Denmark