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Laser or cream? new study tests best treatment for lichen sclerosus

NCT ID NCT05010421

Disease control Sponsor: Ruhr University of Bochum Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two treatments for lichen sclerosus, a chronic skin condition causing itching and pain. 246 women received either a non-ablative CO2 laser treatment or a steroid cream (clobetasol) for three months. The goal was to see which works better at reducing symptoms like burning and pain.

What this could mean

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

Active substance
clobetasol 0.05% cream and non-ablative CO2 laser
What this could lead to
If successful, this could show that laser treatment is as good as or better than standard steroid cream for managing lichen sclerosus symptoms.
What could go wrong
This is a single completed trial, so results may not apply to all patients. Both treatments have side effects like skin irritation or infection.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

246 people

The number who actually took part.

Started

Nov 2021

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Women, age ≥ 18 years * Established diagnosis of LS (vulva and/or perineum and/or perianal region) * Willingness to comply with study requirements * No significant language barrier Exclusion Criteria: * Concurrent immunosuppressive treatment * A history of vulvar cancer and/or vulvar dysplasia * A history of vulvar surgery * A contraindication against clobetasol treatment * A known sun light allergy * A known skin condition interfering with local ablative treatment such as neurodermatitis or bullous pemphigoid

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Conditions

The condition(s) this trial relates to.

lichen sclerosus et atrophicus

As listed by the trial registrant

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

Lichen sclerosus

Contacts and locations

Locations

  • Marien Hospital Herne

    Herne, North Rhine-Westphalia, 44625, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.