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

NCT07278999 | Recruiting DMC

• 2 other identifiers: BNW/NWN/0052/KB1/124/25BNW-1-151/N/5/K
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Lichen Planus; Erosive Lichen Planus; Mucosal Lesions

Keywords

Oral lichen planus; lichen planus; laser; Photobiomodulation therapy; steroids; PDT

Outcome Measures

Primary Outcomes (3)

• Change in erosive oral lichen planus lesion severity using the REA score

  Lesion severity will be measured using the REA scoring system, which evaluates the reticular (R), atrophic (A), and erosive (E) components of oral lichen planus. Each component is quantified from standardized lesion tracings and clinical measurements taken during oral examinations. Scores are calculated according to the protocol formula: REA = (R × 1) + (A × 1.5) + (E × 2). The change in total REA score from baseline reflects the therapeutic effect of each intervention on healing of erosive lesions.

  Baseline to 1 week after completion of assigned treatment

• Efficacy Index (EI) for overall treatment response

  The Efficacy Index (EI) quantifies overall clinical improvement using the formula defined in the study protocol: EI = \[(total REA score before treatment - total REA score after treatment) ÷ total REA score before treatment\] × 100 percent. EI will be used to categorize outcomes as complete healing, significant improvement, moderate improvement, mild improvement, or no improvement.

  Baseline to 1 week after completion of assigned treatment

• Improvement in pain intensity (NB)

  NB represents the percentage improvement in pain based on the Visual Analogue Scale (VAS). It is calculated using the formula: NB = \[(VAS before treatment - VAS after treatment) ÷ VAS before treatment\] × 100 percent. NB will classify improvement as complete, significant, moderate, mild, or absent.

  Baseline to 1 week after completion of assigned treatment

Secondary Outcomes (5)

• Change in lesion size measured in mm²

  Baseline, 1 week, 1 month, and 3 months after treatment completion

• Change in pain intensity using the Visual Analogue Scale (VAS)

  Baseline, 1 week, 1 month, and 3 months after treatment completion

• Change in swelling or oral discomfort (subjective assessment)

  Baseline, 1 week, 1 month, and 3 months after treatment completion

• Change in clinical grade using the Thonprasom scale (0-5)

  Baseline, 1 week, 1 month, and 3 months after treatment completion

• Change in mycological status of oral mucosa

  Baseline and 1 week after treatment completion

Study Arms (3)

Photobiomodulation (PBM)

EXPERIMENTAL

Participants in this arm receive photobiomodulation using a 635 nm diode laser delivered in continuous mode. Energy parameters follow a fixed protocol with 4 J/cm² fluence, 100 mW power, and 15 seconds per treatment point using a noncontact technique. Applications are performed twice weekly until complete epithelial healing or a maximum of eight sessions. This arm evaluates the regenerative and anti-inflammatory effects of PBM for erosive oral lichen planus.

Device: Photobiomodulation using 635 nm diode laser

Photodynamic Laser Therapy - TBO mediated

EXPERIMENTAL

Participants in this arm undergo Photodynamic Therapy using toluidine blue as a photosensitizer activated by a 635 nm diode laser. The protocol applies the photosensitizer in gel form under an occlusive dressing for ten minutes, followed by point-by-point irradiation at a fluence of 120 J/cm² using a glass fiber tip of 8 mm diameter, targeting pathologically altered mucosal tissue while minimizing damage to surrounding healthy epithelium. Treatment is performed once weekly for six consecutive sessions. This arm evaluates whether PDT-mediated photochemical action supports lesion resolution, symptom reduction, and sustained remission in erosive oral lichen planus.

Device: Photodynamic therapy - laser mucosal treatment

Topical Clobetasol 0.05 percent

EXPERIMENTAL

Participants receive standard therapy with topical clobetasol propionate 0.05 percent. The medication is applied to clean, dry oral mucosa twice daily for thirty days following clinical guidelines for erosive oral lichen planus. This arm serves as the comparator for evaluating the effectiveness of laser-based treatments relative to established corticosteroid therapy.

Drug: Clobetasol propionate 0.05 percent topical application

Interventions

Photobiomodulation using 635 nm diode laser DEVICE

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.

Also known as: PBM laser therapy, Low level laser therapy (LLLT)

Photobiomodulation (PBM)

Clobetasol propionate 0.05 percent topical application DRUG

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.

Also known as: Topical corticosteroid

Topical Clobetasol 0.05 percent

Photodynamic therapy - laser mucosal treatment DEVICE

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

Photodynamic Laser Therapy - TBO mediated

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

Department of Periodontology and Oral Mucosa Diseases

Zabrze, Silesian Voivodeship, 41-800, Poland

RECRUITING

MeSH Terms

Conditions

Lichen Planus, Oral; Lichen Planus

Interventions

Lasers, Semiconductor; Low-Level Light Therapy; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Laser Therapy; Therapeutics; Phototherapy; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Dariusz Skaba

  Department of Periodontolody and Oral Mucosa Diseases, Medical University of Silesia

  STUDY CHAIR

• Jakub Fiegler-Rudol

  Department of Periodontolody and Oral Mucosa Diseases, Medical University of Silesia

  PRINCIPAL INVESTIGATOR

• Rafał Wiench

  Department of Periodontolody and Oral Mucosa Diseases, Medical University of Silesia

  STUDY DIRECTOR

Central Study Contacts

Jakub Fiegler-Rudol, PhD candidate

CONTACT

0048531770099; jakub.fieglerrudol@gmail.com

Rafał Wiench, Professor, DMD, PhD

CONTACT

0048574004884; rwiench@sum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be performed by an evaluator who is not involved in treatment delivery and will not have access to information identifying group assignment. Clinical measurements, lesion tracings, and photographic documentation will be coded before evaluation to maintain blinding. The assessor will review only de-identified data, ensuring that scoring of lesion size, mucosal features, and patient-reported measures is conducted independently of the intervention received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to one of three independent treatment arms, each receiving a single intervention throughout the study period. The groups progress through the study simultaneously without crossover, allowing direct comparison of photobiomodulation, Er:YAG laser therapy, and topical clobetasol under a parallel design.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)