Clinical trial NCT06132919: Efficacy and Safety of MC2-25 Cream & Vehicle in Women With Vulvar Lichen Sclerosus (VLS)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vulvar Lichen Sclerosus
Lead sponsor: MC2 Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-11-15
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-group, Randomized, Double-blind
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean change in weekly mean Worst Itch Numeric Rating Score (WI-NRS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: MC2 Therapeutics study site
Study officials:
References: