Status:
COMPLETED
Efficacy and Safety of MC2-25 Cream & Vehicle in Women With Vulvar Lichen Sclerosus (VLS)
Lead Sponsor:
MC2 Therapeutics
Conditions:
Vulvar Lichen Sclerosus
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 subject...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06132919
Start Date
October 11 2023
End Date
November 8 2024
Last Update
October 15 2025
Active Locations (1)
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1
MC2 Therapeutics study site
Kolding, Denmark