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Laser zaps away lichen sclerosus symptoms in new trial

NCT ID NCT06389071

Disease control Sponsor: Sciton Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a fractional 2940 nm laser to treat lichen sclerosus lesions in 50 women aged 18 and older. The laser aims to reduce symptoms like itching, burning, and painful intercourse by removing damaged tissue and promoting healing. Researchers will check tissue samples 16 weeks after treatment to see if the skin has improved.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fractional 2940 nm laser
What this could lead to
If it works, this could offer a non-surgical option to ease symptoms like itching, pain, and tearing in women with lichen sclerosus.
What could go wrong
This is an early study with only 50 participants and no comparison group, so results may not apply widely. Laser treatment may cause temporary discomfort or not improve symptoms for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female aged 18 years or older * Biopsy-proven vulvar lichen sclerosus lesion * Experiencing one or more of the following symptoms of LS: 1. Dryness 2. Itching 3. Burning 4. Bleeding 5. Blistering 6. Soreness 7. Easily bruises 8. Easily tears 9. Ulcerated lesions 10. Painful intercourse * Negative urine pregnancy test if subject is of childbearing potential before enrollment * Absence of vulvovaginal infection i.e. fungi, bacterial vaginosis, and STI * Ability to understand and sign informed consent, questionnaires, and all investigation requirements * Willing to consent to clinical photographs of the treatment area * Willing to consent to ultrasound images of the treatment area * Willing and able to logistically follow schedule of treatments and follow-up visits Exclusion Criteria: * Pregnancy, less than 3 months postpartum, or planning to become pregnant during the investigation to protect integrity of the data * Is a nursing mother * History of uncontrolled malignant disease * Active urogenital infection or chronic infection (i.e., candida, herpes, herpes simplex, bacterial vaginosis, trichomoniasis, or other infection) * Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich syndrome) * Subjects with genital skin disease, psoriasis due to risk of koeberizing * Subjects on immunosuppressants: mycophenolate, retinoids, azathioprine, cyclosporin * Known allergy or intolerance to local anesthesia * Known history of connective tissue disease * Known propensity for keloid formations * Known medical condition that may affect wound healing * Any reason that the investigator deems prohibits participation in the investigation

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Conditions

The condition(s) this trial relates to.

lichen sclerosus et atrophicus vulvar lichen sclerosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lichen sclerosus lesion

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Clinique Medicale Uro-Gyneco de l'Abitibi

    RECRUITING

    Val-d'Or, Quebec, J9P1W1, Canada

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