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Laser and steroid mouthwash aim to tame painful mouth sores in autoimmune disease

NCT ID NCT07641725

Disease control Sponsor: Damascus University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a steroid mouthwash (clobetasol propionate 0.05%) and low-level laser therapy, alone or together, can heal painful mouth sores in people with pemphigus vulgaris—a chronic autoimmune disease that causes blisters on skin and mucous membranes. Thirty participants with active oral lesions will be randomly assigned to one of three groups: mouthwash only, laser only, or both. The goal is to see if these topical treatments can reduce lesion severity and pain, potentially allowing patients to lower their systemic steroid doses and avoid long-term side effects.

What this could mean

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

Active substance
clobetasol propionate 0.05% mouthwash and photobiomodulation (low-level laser therapy)
What this could lead to
If effective, these topical treatments could speed healing of oral lesions and allow patients to lower their steroid doses, reducing long-term side effects.
What could go wrong
This is a small, early-stage study with only 30 participants, so results may not apply broadly. The treatments are supportive, not a replacement for systemic therapy.

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 30 people

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

Started

Nov 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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 to 80 years

Sex

Anyone

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: 1. Confirmed diagnosis of Pemphigus Vulgaris based on clinical presentation, histopathology, and immunopathological findings (positive direct and indirect immunofluorescence), according to World Health Organization (WHO) standards. 2. Presence of active erosive or ulcerative oral lesions with a maximum diameter exceeding 1 cm. 3. Patients currently maintained on a stable systemic corticosteroid regimen not exceeding 1 mg/kg/day. Exclusion Criteria: 1. Co-existing chronic systemic conditions, including significant gastrointestinal disorders or uncontrolled diabetes mellitus. 2. History or current evidence of malignancy. 3. Concurrent use of systemic antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), or hormonal therapies that may interfere with the study outcomes. 4. Pregnancy or active lactation. Note: These criteria are strictly enforced to ensure that the study population remains homogeneous regarding the systemic treatment protocol.

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Conditions

The condition(s) this trial relates to.

pemphigus vulgaris

As listed by the trial registrant

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

Oral lesions in patients with pemphigus vulgaris

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

Locations

  • Department of Oral Medicine, Faculty of Dental medicine

    RECRUITING

    Damascus, Syria

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