Efficacy and Safety of MC2-25 Cream & Vehicle in Women With Vulvar Lichen Sclerosus (VLS) (NCT06132919) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of MC2-25 Cream & Vehicle in Women With Vulvar Lichen Sclerosus (VLS)
Denmark33 participantsStarted 2023-10-11
Plain-language 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).
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS)