Recruiting

Study on Clobetasol, Mometasone, and Tacrolimus for Treating Vulvar Lichen Sclerosus in Children

Verified siteRegistered drugNo 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 the treatment of lichen sclerosus of the vulva in children and teenagers. Lichen sclerosus is a skin condition that affects the genital area, causing itching, discomfort, and changes in skin appearance. The study will test three different ointments: clobetasol propionate, mometasone furoate, and tacrolimus. These medications are applied directly to the skin to help reduce inflammation and improve symptoms.

The purpose of the study is to compare how effective and safe these treatments are for young patients. Participants will be divided into three groups, each receiving one of the ointments. The study will last for about 12 weeks, during which the participants will apply the ointment to the affected area as directed. Researchers will monitor the participants to see how well the treatments work in reducing symptoms and improving the quality of life.

Throughout the study, the impact of various factors such as age, immune system function, and genetic makeup on the treatment's effectiveness will also be evaluated. The goal is to find the best treatment option for managing lichen sclerosus in the pediatric population, ensuring both safety and improvement in symptoms.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, ensure that informed consent has been obtained from your parent or legal representative. If you are 13 years of age or older, your consent is also required.
Confirm that you meet the eligibility criteria, including being between 2 to 18 years old, having a clinical diagnosis of vulval lichen sclerosus, and being in good general health.
Step 2
Initial assessment
Undergo a physical examination to confirm your good general condition.
Ensure normal levels of ACTH (a hormone) and cortisol are present.
Verify that you are not in the phase of active immunization, with a minimum interval of 2 weeks between immunization and taking a dose of the investigational medicinal product.
Step 3
Treatment assignment
You will be randomly assigned to one of three treatment groups: Arm I with 0.05% clobetasol propionate, Arm II with 0.1% mometasone furoate, or Arm III with 0.03% tacrolimus.
All treatments are applied topically, meaning they are applied directly to the skin.
Step 4
Treatment administration
Apply the assigned medication as instructed. The frequency and duration of application will be provided by the study team.
Continue the treatment for a period of 12 weeks, during which the efficacy and safety of the treatment will be evaluated.
Step 5
Follow-up assessments
Attend regular follow-up visits as scheduled by the study team to monitor your progress and any side effects.
The primary goal is to achieve a significant clinical improvement, defined as a minimum 75% reduction in symptoms and a 50% improvement in quality of life after 12 weeks.
Step 6
Long-term evaluation
A secondary evaluation will occur 15 months after starting treatment to assess the long-term effectiveness of the treatment.
This evaluation will focus on maintaining the reduction of symptoms and improvement in quality of life.

Who can join the trial?

9 criteria

Age between 2 and 18 years old.
Must have a confirmed clinical diagnosis of vulval lichen sclerosus.
Need to have informed voluntary consent from a parent or legal representative for participation in the study. If the patient is 13 years or older, they must also give their consent.
Must be able and willing to follow the study's requirements.
No medical reasons preventing the use of any components of the study medications.
Must be in good general health based on a physical examination.
Must score at least 1 point on the Sn-LTS scale (a scale used to measure the severity of symptoms).
Must have normal levels of ACTH (corticotropin) hormone and cortisol (hormones related to stress and metabolism).
Must not be in the phase of active immunization, meaning there should be at least a 2-week gap between any vaccination and taking a dose of the study medication.

Who cannot join the trial?

4 criteria

Patients who do not have a clinical diagnosis of lichen sclerosus of the vulva cannot participate. Lichen sclerosus is a skin condition that affects the vulva.
Only female patients are eligible; male patients cannot participate.
Patients outside the specified age range cannot participate. The study is for a specific age group.
Patients who are not part of the vulnerable population selected for this study cannot participate. A vulnerable population may include groups like children or those with certain health conditions.

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Verified sites

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Uniwersytecki Szpital Dzieciecy W Lublinie
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Lublin, Poland

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Investigated drugs

Clobetasol
is a strong medication used to reduce inflammation and relieve symptoms like itching and redness. In this trial, it is being tested to see how well it works and how safe it is for treating a condition called lichen sclerosus, which affects the skin of the vulva in children.
Mometasone
is another medication that helps to reduce inflammation and ease symptoms such as itching and swelling. This trial is examining its effectiveness and safety in treating lichen sclerosus in the vulva of children, comparing it to other treatments.
Tacrolimus
is a medication that works by suppressing the immune system to reduce inflammation and other symptoms. In this study, it is being evaluated for its ability to treat lichen sclerosus in the vulva of children, alongside other treatments, to determine how well it works and how safe it is.

What is already known about the treatment

Clobetasol
Clobetasol is a medication applied topically, meaning it is used directly on the skin, in the form of a cream or ointment. It is currently being studied for its effectiveness and safety in treating lichen sclerosus of the vulva, particularly in children. This medication is primarily used to reduce inflammation and relieve symptoms like itching and discomfort. At the molecular level, clobetasol works by suppressing the immune response and reducing the production of substances in the body that cause inflammation. It is classified as a potent corticosteroid.
Mometasone
Mometasone is administered as a topical cream or ointment, applied directly to the affected skin area. It is being evaluated in clinical trials for its role in treating lichen sclerosus of the vulva in pediatric patients. The main use of mometasone is to alleviate inflammation and itching associated with skin conditions. It acts by inhibiting the release of inflammatory substances in the body, thereby reducing swelling and irritation. Mometasone belongs to the class of medications known as corticosteroids.
Tacrolimus
Tacrolimus is used as a topical ointment, applied to the skin, and is under investigation for its potential benefits in treating lichen sclerosus of the vulva in children. It is primarily indicated for reducing inflammation and immune responses in the skin. Tacrolimus works by blocking the activity of certain immune cells, which helps to decrease inflammation and prevent flare-ups. It is classified as a calcineurin inhibitor, which is a type of immunosuppressant.

Investigated diseases

Lichen Sclerosus – Lichen sclerosus is a chronic skin condition that primarily affects the genital and anal areas, causing patches of thin, white, and wrinkled skin. It is more common in women, particularly affecting the vulva, but can also occur in men and children. The disease progresses with symptoms such as itching, discomfort, and sometimes pain, especially during sexual intercourse or urination. Over time, the affected skin may become scarred and more fragile, leading to further complications. The exact cause of lichen sclerosus is unknown, but it is believed to involve an overactive immune response. The condition can fluctuate, with periods of remission and flare-ups.