NCT07278999 Photobiomodulation, Photodynamic Therapy, and Clobetasol in the Treatment of Oral Lichen Planus.

Eligibility & Interventions

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What to Expect as a Participant

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This trial targets 60 participants in total. It began in 2025-12-01 with a primary completion date of 2026-10.

Brief Summary

This study aims to compare three treatment approaches for the erosive form of oral lichen planus, a chronic inflammatory condition that often causes pain, impaired oral function, and frequent relapses. Sixty adults with a confirmed diagnosis will be randomly assigned to photobiomodulation, Photodynamic Therapy, or topical clobetasol, which serves as the current standard of care. The project investigates how effectively each method promotes healing of erosive lesions, reduces pain, improves oral functions such as chewing and swallowing, and prevents recurrence after treatment. Before enrollment, participants will undergo microbiological testing, tissue autofluorescence assessment, and histopathological confirmation. Treatment will follow strict protocols tailored to each therapy type, with PBM applied twice weekly, PDT administered once weekly for six consecutive weeks using toluidine blue as a photosensitizer activated by a 635 nm diode laser, and clobetasol used twice daily for thirty days. Clinical outcomes will be measured using lesion size, standardized scoring systems, and patient-reported scales for pain and swelling. Follow up at one week, one month, and three months will document healing progress and relapse rates. Safety monitoring includes evaluation for infections and adverse reactions. The expected outcome is to determine which therapy provides the most effective, safe, and durable improvement. The study may offer evidence supporting laser based methods as alternatives that avoid the risks associated with long term steroid use.

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.

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