Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

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)

This research study is looking into a new cream, called MC2-25, for women who have a skin condition called vulvar lichen sclerosus (VLS). VLS can cause itching, pain, and skin changes in the sensitive area of the vulva. The main goal is to find out if MC2-25 cream is effective in reducing the severe itching that many women with VLS experience, compared to a cream that looks the same but doesn't contain the active medicine. The study will last for 12 weeks, and participants will be women aged 18 and older. This is an early-stage study, meaning researchers are exploring its potential benefits and looking carefully at its safety.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Mc2 Therapeutics Limited

Enrolment target

Start

09 Oct 2023

Vulvar lichen sclerosus (VLS)

What is this study about?

This research study is about finding a new way to help women who have a skin condition called vulvar lichen sclerosus, often shortened to VLS. VLS can be really uncomfortable, causing things like intense itching, pain, and sensitive skin in the vulva area. Researchers are testing a new cream, called MC2-25, to see if it can ease these symptoms.

The study will compare MC2-25 cream with another cream that looks exactly the same but doesn't have the active medicine in it. This is a common way to test new treatments, as it helps researchers see if any improvements are genuinely due to the medicine or just to the act of applying a cream. Neither you nor your study doctor will know which cream you are using, which helps keep the results fair and unbiased.

Over 12 weeks, researchers will closely watch how much the cream helps with symptoms, especially the worst itching you might experience. They will also look at pain levels and other measures of how the condition affects your daily life. This type of study is an early step in finding new treatments, aiming to discover if the cream is both helpful and safe for women with VLS.

Key takeaways

This study tests a new cream (MC2-25) for women with vulvar lichen sclerosus (VLS).
It aims to reduce itching and pain from VLS over 12 weeks.
Participants will receive either the active cream or a cream without medicine.
Your progress will be monitored through symptom diaries and clinic visits.
You must be a woman, aged 18 or over, with a VLS diagnosis to take part.

Who may be eligible?

This study is specifically for women who have been diagnosed with vulvar lichen sclerosus (VLS).

To be considered for this study, you must be at least 18 years old. There is no upper age limit, so women of all adult ages are welcome to inquire. The study focuses purely on women with VLS.

Your study doctor will discuss your full medical history and current health to make sure this study is the right and safest choice for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a confirmed diagnosis of vulvar lichen sclerosus (VLS)?
Am I female?
Am I 18 years old or older?
Am I willing to use a cream daily for 12 weeks?
Am I able to attend several clinic visits over 12 weeks?
Am I able to keep a diary of my symptoms?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be involved for about 12 weeks. During this time, you would regularly apply one of two creams to your vulva area – either the new MC2-25 cream or a cream that looks the same but doesn't contain the active medicine. You will be given a diary to fill in regularly, noting down how your symptoms, like itching and pain, are changing. This will help the researchers understand if the cream is working.

You will have several visits to the clinic so the study team can check on your progress and safety. They will ask you questions about your symptoms and might do some examinations. After the 12 weeks of using the cream, there might be a final follow-up visit. The study team will explain all the details, including the number of visits and what each visit will involve.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the MC2-25 cream helps improve your symptoms like itching and pain. However, there's also a chance you could receive the cream that doesn't contain the active medicine, so it might not help your symptoms. As with any new medicine, there could be side effects or discomfort from the cream, even with the cream that doesn't contain active medicine. These will be carefully monitored by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is vulvar lichen sclerosus (VLS)?

VLS is a long-term skin condition that mainly affects the skin around the vulva. It can cause thinning of the skin, itching, pain, and sometimes scarring.

What does 'double-blind' mean?

It means that neither you nor your study doctor will know whether you are receiving the active MC2-25 cream or the cream without the active medicine. This helps keep the study fair.

Why use a 'vehicle' cream?

The 'vehicle' cream is the same as the active cream but without the medicine. It's used for comparison to ensure any improvements seen are truly because of the active drug, not just the cream itself.

How long will I be in the study?

Your participation in the study will last for 12 weeks, during which you will use the cream and attend clinic visits.

Will I still receive my usual treatment for VLS?

The study team will discuss this with you. Often, for clinical trials, participants might temporarily stop or adjust their usual treatment for the study duration, but this will be clearly explained.