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Study on the Effectiveness and Safety of MC2-25 Cream for Women with Vulvar Lichen Sclerosus

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called vulvar lichen sclerosus (VLS), which affects the skin around the vulva, causing symptoms like itching and pain. The trial will test a new treatment called MC2-25 cream, which contains an active ingredient known as alanyl glutamine. The study will compare the effects of this cream to a similar cream that does not contain the active ingredient, referred to as the MC2-25 vehicle.

The purpose of the study is to explore how effective and safe the MC2-25 cream is for women diagnosed with vulvar lichen sclerosus. Participants in the study will be randomly assigned to one of two groups. One group will receive the MC2-25 cream, while the other group will receive the MC2-25 vehicle. Neither the participants nor the researchers will know which treatment each participant is receiving, a method known as "double-blind." The study will last for 12 weeks, during which participants will apply the cream daily and keep a diary of their symptoms.

Throughout the study, researchers will monitor changes in symptoms such as itching and pain, using a scale called the Worst Itch Numeric Rating Score (WI-NRS) and the Worst Pain Numeric Rating Score (WP-NRS). The goal is to see if the MC2-25 cream provides significant relief compared to the MC2-25 vehicle. Participants will also complete a questionnaire called the Skindex-29 to assess the impact of the treatment on their quality of life. The study aims to provide valuable information on the potential benefits of the MC2-25 cream for managing vulvar lichen sclerosus.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and baseline assessment
Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the MC2-25 cream or the MC2-25 vehicle (a cream without the active substance).
A baseline assessment will be conducted to evaluate your current condition. This includes recording your Worst Itch Numeric Rating Score (WI-NRS) and Worst Pain Numeric Rating Score (WP-NRS).
Step 2
Treatment phase
During the 12-week treatment phase, apply the assigned cream topically as instructed. The cream should be applied to the affected areas as per the guidelines provided by the study team.
You will be required to maintain a daily diary to record your WI-NRS and WP-NRS scores. This will help track any changes in your symptoms over the course of the study.
Step 3
Weekly assessments
Each week, your diary entries will be reviewed to assess the mean change in your weekly WI-NRS and WP-NRS scores. This will help determine the effectiveness of the treatment.
The study aims to observe improvements in your symptoms, specifically looking for a significant reduction in itch and pain scores.
Step 4
Final assessment
At the end of the 12-week period, a final assessment will be conducted. This will include a review of your diary entries and an evaluation of any changes in your condition.
The primary goal is to measure the mean change in your weekly WI-NRS from the baseline to the end of the study. Secondary goals include assessing changes in your WP-NRS and other quality of life measures.

Who can join the trial?

14 criteria

Women of any race or ethnicity who are 18 years or older.
Women who can have children must agree to use a very reliable form of birth control while participating in the study.
Must be able to understand the study and agree to follow the study requirements.
Must have signed a document agreeing to participate in the study.
Must have a clinical diagnosis of **Vulvar Lichen Sclerosus (VLS)** made by a skin or women's health doctor familiar with VLS.
Must have at least one sign of VLS, such as:
**Hyperkeratosis**: Patches of bright white skin with a powdery texture.
**Sclerosis**: Areas of yellowish or ivory white skin with a smooth, waxy, or firm texture, often seen on certain parts of the vulva.
Must have noticed the first symptoms of VLS, like itching or pain, at least 6 months before starting the study.
Must have recorded at least four itch scores in a diary before the study starts.
Must have at least moderate itching, defined as an average itch score of 4 or more, based on diary entries before the study starts.
Women must be either:
Not able to have children, such as being post-menopausal (no periods for 12 months without another medical reason) or surgically sterile.
Or able to have children but must have a negative pregnancy test before starting the study.

Who cannot join the trial?

4 criteria

Patients who are not female cannot participate.
Patients who do not have **vulvar lichen sclerosus (VLS)** cannot participate. VLS is a skin condition affecting the vulva, which is the outer part of the female genitalia.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
Patients who belong to a vulnerable population may not be eligible. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Herlev Hospital
Herlev, Denmark
Verified
Odense University Hospital
Odense, Denmark
Verified
Regionshospital Nordjylland
Hjørring, Denmark

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Investigated drugs

MC2-25 cream is a topical treatment being tested for its effectiveness and safety in women with vulvar lichen sclerosus, a chronic skin condition affecting the vulva. The cream is applied directly to the affected area to help alleviate symptoms and improve skin condition. The trial aims to determine how well this cream works in comparison to a non-active version of the cream.

Alanyl Glutamine

What is already known about the treatment

MC2-25 Cream – This medication is administered topically as a cream, applied directly to the affected area. It is currently being studied in clinical trials for its effectiveness and safety in treating vulvar lichen sclerosus (VLS), a chronic skin condition. The main therapeutic indication is to alleviate symptoms associated with VLS. The mechanism of action at the molecular level involves modulating inflammatory pathways to reduce skin inflammation and discomfort. It is classified pharmacologically as a topical anti-inflammatory agent.

Investigated diseases

Vulvar Lichen Sclerosus – Vulvar lichen sclerosus is a chronic skin condition that affects the vulva, leading to white patches of skin that may become thin and fragile. It is often accompanied by itching, which can be severe, and sometimes pain or discomfort. The condition can cause changes in the appearance of the vulva, such as scarring or shrinkage of the affected areas. Over time, the skin may become more prone to tearing or bleeding. The exact cause of vulvar lichen sclerosus is not well understood, but it is believed to involve an autoimmune response. It is more common in postmenopausal women but can occur at any age.