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RecruitingNAINTERVENTIONAL

Laser Treatment for Lichen Sclerosus

This research study is exploring a new way to treat lichen sclerosus, a skin condition that often affects the vulva. The treatment involves using a special type of laser (called a fractional 2940 nm laser) on the affected areas. The main goal is to see if this laser can help reduce uncomfortable symptoms like dryness, itching, burning, and pain that many women with lichen sclerosus experience. This study is for women aged 18 and over who have been diagnosed with vulvar lichen sclerosus by a biopsy and are experiencing these symptoms. Researchers want to find a new option that could improve the quality of life for those living with this condition.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Sciton
Enrolment target
50
Start
01 Mar 2024
Estimated completion
30 Dec 2027

What is this study about?

Lichen sclerosus is a long-lasting skin condition that mostly affects the genital area, particularly the vulva in women. It can make the skin thin, white, and crinkled, causing uncomfortable symptoms such as itching, burning, soreness, and pain during sex. While current treatments, like steroid creams, can help manage symptoms, researchers are always looking for new and more effective options.

This study is investigating a different approach: using a special medical laser called a fractional 2940 nm laser. This type of laser creates tiny, controlled dots on the skin's surface. The idea is that these tiny injuries encourage the skin to heal and regenerate, potentially improving its health and reducing the troublesome symptoms of lichen sclerosus. The researchers want to understand how well this laser treatment works and if it can offer lasting relief.

If you have been diagnosed with lichen sclerosus and are struggling with these symptoms, this study could offer insight into a new treatment option. By participating, you would be helping medical science learn more about how to best treat this condition, potentially benefiting many others in the future.

Key takeaways

  • Investigates a laser treatment for lichen sclerosus symptoms.
  • For women aged 18+ with biopsy-proven vulvar lichen sclerosus.
  • Aims to reduce itching, burning, dryness, and pain.
  • Involves multiple laser treatment sessions and follow-up checks.
  • Participation is voluntary; you can withdraw at any time.

Who may be eligible?

This study is looking for women aged 18 or older who have been officially diagnosed with lichen sclerosus in the vulvar area through a biopsy. You should also be experiencing at least one of the common symptoms of lichen sclerosus, such as dryness, itching, burning, soreness, or pain during sex.

There are some reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or planning to become pregnant soon, you won't be able to take part. Also, you shouldn't have any active infections in the genital area, uncontrolled cancer, or certain conditions that affect your immune system or wound healing. If you are taking certain medications that suppress your immune system, you would also not be eligible.

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.

  1. Am I a woman aged 18 or older?
  2. Have I been diagnosed with lichen sclerosus in the vulva area by a doctor?
  3. Do I have symptoms like itching, burning, pain, or dryness?
  4. Am I NOT pregnant, breastfeeding, or planning a pregnancy soon?
  5. Do I NOT have any current genital infections?
  6. Am I able to attend regular appointments for treatment and check-ups?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a thorough check-up to make sure you meet all the requirements. You would need to sign a consent form, meaning you understand what the study involves. During the study, you would have the laser treatment applied to the affected area. This is likely to involve several treatment sessions over a period of time, followed by follow-up visits.

Researchers will observe how your skin responds to the treatment. This will include taking photographs and ultrasound images of the treated area to track changes. You would also be asked to fill out questionnaires about your symptoms to help understand how the treatment affects you. It's important to be able to attend all scheduled treatment sessions and follow-up visits.

Potential risks and benefits

Every medical treatment comes with potential benefits and risks. For this study, the potential benefit is that the laser treatment might reduce your lichen sclerosus symptoms, improving your comfort and quality of life. However, there's no guarantee it will work for everyone, and you might experience side effects like temporary redness, swelling, discomfort, or changes in skin colour in the treated area. It's very important to understand that your participation is completely voluntary, and you can change your mind and withdraw from the study at any time without affecting your medical care.

Locations (1)

  • Clinique Medicale Uro-Gyneco de l'Abitibi
    Verified postcode
    Val-d'Or, Canada· Recruiting

Common questions

What is lichen sclerosus?

It's a long-term skin condition that usually causes thin, white patches of skin, most often in the genital area, leading to itching, burning, and soreness.

What kind of laser is being used?

The study uses a fractional 2940 nm laser, which makes tiny, precise changes to the skin to encourage healing and reduce symptoms.

Who can join this study?

Women aged 18 and older, diagnosed with vulvar lichen sclerosus by biopsy, and experiencing typical symptoms like itching or pain.

Will I need to go to many appointments?

Yes, taking part involves several treatment sessions and follow-up visits, so you need to be able to attend regularly.

Can I stop participating if I want to?

Absolutely, you can withdraw from the study at any time for any reason, and it won't affect your medical care.

How to find out more

J Patel

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Laser Treatment for Lichen Sclerosus…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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