Light-based therapies versus clobetasol gel for erosive oral lichen planus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Sixty adults with biopsy-confirmed erosive oral lichen planus will be randomly assigned to one of three treatments: photobiomodulation (low-level 635 nm diode laser twice weekly), photodynamic therapy (toluidine blue plus 635 nm laser once weekly for six weeks), or topical clobetasol propionate 0.05% applied twice daily for thirty days. Before enrollment, participants undergo microbiological testing, tissue autofluorescence assessment, and histopathological confirmation to ensure appropriate diagnosis and rule out infection. Outcomes include lesion healing, pain reduction, improvements in oral function (chewing/swallowing), and recurrence after treatment, measured with standardized protocols. Treatments follow predefined delivery parameters to compare effectiveness and safety across the three approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Be between 20 and 70 years old.
* Have histologically confirmed erosive or ulcerative oral lichen planus based on a biopsy.
* Have no active aerobic bacterial infection or oral fungal infection.
* Have had no treatment for OLP within the past 3 months.
* Provide written informed consent.

Exclusion Criteria:

* Systemic diseases or conditions such as uncontrolled diabetes (random glucose ≥200 mg/dl), cardiovascular failure, or a pacemaker.
* Autoimmune/connective tissue diseases such as lupus with positive ANA testing.
* Current or past cancer, graft-versus-host disease, or hematologic disorders (anemia, leukemia, lymphoma, bleeding disorders, hemophilia, von Willebrand disease).
* Enzymatic or metabolic disorders such as G6PD deficiency (favism) or porphyria.
* Viral hepatitis A, B, or C.
* Recent vaccinations (within the past 6 months).
* Use of medications known to trigger lichenoid reactions, including:
* Antihypertensives (beta-blockers, diuretics, ACE inhibitors, centrally acting agents).
* Oral antidiabetics (sulfonylureas).
* Metal-containing compounds (lithium, gold, arsenic, mercury).
* NSAIDs (e.g., ibuprofen).
* Antibiotics/chemotherapeutics (tetracyclines, sulfonamides).
* Pregnancy or breastfeeding (including up to 6 months post-lactation).
* Photosensitivity to UV light.
* Smoking more than 5 cigarettes per day.
* Lesions located adjacent to amalgam fillings or metal prosthetic restorations.
* Any degree of dysplasia on histopathology.
* Treatment for OLP within the last 3 months.
* Active oral fungal or bacterial infection at screening.
* Lack of consent to participate.

Where it's running

• Department of Periodontology and Oral Mucosa Diseases
  Zabrze, Silesian Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Jakub Fiegler-Rudol — Department of Periodontolody and Oral Mucosa Diseases, Medical University of Silesia
• Study coordinator: Jakub Fiegler-Rudol, PhD candidate
• Email: jakub.fieglerrudol@gmail.com
• Phone: 0048531770099

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.