NCT06132919

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: MC2 Therapeutics · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	MC2-25 cream	Topical application
DRUG	MC2-25 vehicle	Topical application

Timeline

• Start date: 2023-10-11
• Primary completion: 2024-11-08
• Completion: 2024-11-08
• First posted: 2023-11-15
• Last updated: 2025-10-15
• Results posted: 2025-10-15

Locations

1 site across 1 country: Denmark