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

Effectiveness of Photobiomodulation, Photodynamic Therapy, and Clobetasol in the Treatment of the Erosive Form of Oral Lichen Planus - a Randomized Clinical Trial.

This trial will test whether two light-based treatments (photobiomodulation or photodynamic therapy) or standard topical clobetasol better heal erosive oral lichen planus, reduce pain, and prevent recurrence in adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 20 Years to 70 Years
• Sex: All
• Sponsor: Medical University of Silesia (Academic / other)
• Locations: 1 site (Zabrze, Silesian Voivodeship)
• Trial ID: NCT07278999 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20–70 with histologically confirmed erosive or ulcerative oral lichen planus, no recent OLP treatment within three months, and no active oral bacterial or fungal infection.

Not a fit: People with uncontrolled systemic disease (for example uncontrolled diabetes, cardiac failure, pacemaker), certain autoimmune conditions, recent vaccinations, viral hepatitis, G6PD deficiency or porphyria, current/past cancer or hematologic disorders, or on medications known to trigger lichenoid reactions may be excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the trial could identify an effective steroid-sparing or superior therapy that improves healing, reduces pain, and lowers recurrence for people with erosive oral lichen planus.

How similar studies have performed: Topical corticosteroids are the established standard and smaller studies have shown promising but not definitive benefits for photobiomodulation and photodynamic therapy as alternative or adjunctive options.

Eligibility criteria

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 this trial is running

Zabrze, Silesian Voivodeship

• 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

Conditions Oral Lichen Planus; Erosive Lichen Planus; Mucosal Lesions; Oral lichen planus; lichen planus; laser; Photobiomodulation therapy; steroids