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

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.

Conditions

• Oral Lichen Planus
• Erosive Lichen Planus
• Mucosal Lesions

Interventions

DEVICE

Photobiomodulation using 635 nm diode laser

Photobiomodulation is delivered with a 635 nm diode laser in continuous mode at 100 mW, fluence 4 J/cm², and power density 0.2 W/cm². Each point is irradiated for 15 seconds using a noncontact technique with an 8 mm flat glass fiber tip and a 0.5 cm² spot size. Treatment points are spaced 2-3 mm apart over the lesion surface. Sessions are performed twice weekly until complete epithelial healing or for a maximum of eight sessions. This intervention aims to modulate inflammation and support mucosal repair in erosive oral lichen planus.

DEVICE

Photodynamic therapy - laser mucosal treatment

Photodynamic Therapy is performed using toluidine blue gel as a photosensitizer, applied to the affected mucosal surface under an occlusive dressing for ten minutes. Following removal of the dressing and excess photosensitizer, irradiation is carried out using a 635 nm diode laser (Smart M®, Lasotronix) operating in continuous-wave mode at an output power of 400 mW and a power density of 0.8 W/cm². A flat glass fiber tip of 8 mm diameter is used in a noncontact mode at a distance of approximately 1 mm from the lesion surface. Irradiation is applied point by point at a fluence of 120 J/cm² per point, with the duration of each point irradiation set at 2 minutes and 32 seconds; the total number of points and overall session duration are determined by lesion extent. Following irradiation, the photosensitizer is left in place for an additional three minutes before removal by oral rinsing with water. Sessions are conducted once weekly for six consecutive treatments. This intervention evaluat

DRUG

Clobetasol propionate 0.05 percent topical application

Participants apply clobetasol propionate 0.05 percent directly to clean, dry oral mucosa twice daily for thirty days. The medication is used according to standard clinical practice for erosive oral lichen planus. The formulation serves as the active comparator to evaluate how laser-based treatments perform relative to conventional corticosteroid therapy. Participants are instructed to avoid eating, drinking, or rinsing for at least 30 minutes after application to ensure adequate mucosal contact.

Sponsors & Collaborators

• Medical University of Silesia

  lead OTHER

Principal Investigators

• Dariusz Skaba · Department of Periodontolody and Oral Mucosa Diseases, Medical University of Silesia

• Jakub Fiegler-Rudol · Department of Periodontolody and Oral Mucosa Diseases, Medical University of Silesia

• Rafał Wiench · Department of Periodontolody and Oral Mucosa Diseases, Medical University of Silesia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2026-10-31

Completion

2026-11-30

Countries

• Poland

Study Locations