An interventional study of Photobiomodulation using 635 nm diode laser and Photodynamic therapy - laser mucosal treatment in Oral Lichen Planus, Erosive Lichen Planus and Mucosal Lesions, sponsored by Medical University of Silesia. Recruiting at 1 site in Poland. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Medical University of Silesia · Not applicable, Interventional, and Treatment
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.
The study investigates three therapeutic approaches for managing the erosive form of oral lichen planus, a chronic inflammatory disorder of the oral mucosa characterized by persistent mucosal damage, pain, and the risk of recurrent symptoms. The erosive phenotype is clinically significant because it often leads to functional limitations, such as difficulty eating, impaired tolerance of removable prostheses, and reduced quality of life. Standard therapy relies primarily on potent topical corticosteroids, yet this approach is frequently limited by incomplete remission, recurrence after withdrawal, and the potential for local adverse effects, including mucosal atrophy and secondary candidiasis. For these reasons, alternative treatment modalities have gained increasing clinical interest, particularly those based on light-based therapies capable of modulating cellular processes or removing pathologic tissue with minimal collateral injury. Photobiomodulation and Photodynamic Therapy represent two distinct applications of light energy. Photobiomodulation delivers low energy laser light that supports biological repair mechanisms, reduces inflammatory mediator activity, and enhances tissue regeneration without inducing thermal damage. PDT combines a photosensitizing agent with a light source of specific wavelength, which activates the photosensitizer to generate reactive oxygen species capable of selectively targeting pathologically altered tissue while limiting damage to surrounding healthy mucosa. This contributes to a reduction in lesion activity and supports mucosal recovery through localized cytotoxic and immunomodulatory mechanisms. Although each method has been investigated in smaller clinical series, direct comparisons among photobiomodulation, PDT, and topical corticosteroids remain limited, especially when applied to the erosive variant of oral lichen planus. The study follows a parallel group design with allocation governed by block randomization to maintain balanced group sizes. Participants undergo diagnostic workup before allocation to ensure accurate confirmation of the disease subtype and to exclude other mucosal disorders with overlapping features. Autofluorescence imaging is used as part of the diagnostic process to support precise selection of biopsy site and to assist in distinguishing inflammation from dysplasia or other pathology. Only patients with disease confined to the oral mucosa and without evidence of systemic illness that could influence healing potential proceed to treatment. Interventions are performed using standardized protocols that reflect current best practices for each modality. Photobiomodulation is delivered with a diode laser operating under controlled parameters designed to stimulate repair pathways. The PDT intervention uses toluidine blue as a photosensitizer applied under an occlusive dressing, followed by irradiation with a 635 nm diode laser to activate the photosensitizer and induce targeted cytotoxic effects within the affected mucosa. The control arm uses a topical corticosteroid formulation routinely employed in dental medicine for erosive lesions, with instructions provided to support maximal mucosal contact time. During the treatment period, clinicians document changes in lesion characteristics using standardized measurement tools that allow objective quantification of mucosal surface area and morphological alterations. Photographic records supplement clinical scoring to ensure consistency across follow up visits. Pain severity and functional disturbances are captured with validated numeric scales, supporting a comprehensive evaluation that includes both clinical and patient centered components. Follow up assessments take place after treatment completion to examine the durability of mucosal healing. Given that erosive oral lichen planus often recurs, these visits are critical to understanding whether any modality provides sustained remission. Monitoring includes microbiological evaluation to detect any changes in colonization patterns, such as the emergence of yeast species that may influence treatment response or cause secondary symptoms. Safety oversight focuses on identifying adverse reactions such as erythema, mucosal irritation, delayed healing, dyschromia, or any unexpected tissue responses. Light based methods are generally regarded as safe when applied within established energy ranges, yet ongoing surveillance helps detect rare events or individual sensitivities. The protocol outlines criteria for early discontinuation when significant symptom exacerbation or other concerning findings emerge. This study is structured to deliver high quality comparative data that can guide clinical decision making when standard therapy is insufficient, poorly tolerated, or contraindicated. By evaluating three therapeutically relevant modalities, the study seeks to determine which approach most effectively promotes epithelial recovery, reduces symptom burden, and supports functional comfort. Its focus on recurrence patterns adds an important dimension, as durable improvement is often challenging to achieve in erosive oral lichen planus. The results may clarify the advantages of low level laser applications, the immunomodulatory and antimicrobial properties of PDT, and the role of corticosteroids as a benchmark comparator. Photobiomodulation may demonstrate benefits related to noninvasiveness and absence of steroid related adverse effects. PDT may emerge as a precise alternative capable of controlling symptoms and accelerating mucosal healing through targeted photochemical action while avoiding systemic adverse effects. The study's methodology and extended observation window aim to support evidence based refinements to clinical protocols and promote therapeutic strategies aligned with patient comfort, safety, and long term disease control. The broader significance of the project lies in its potential to improve management of a chronic condition that has meaningful impact on daily activities and overall well being. By integrating structured clinical measurements, patient reported data, and advanced imaging methods, the study seeks to produce a comprehensive dataset that reflects contemporary standards in oral medicine research. The findings may pave the way for future work exploring predictors of treatment success, optimal photosensitizer concentrations and energy parameters for PDT, and potential combination approaches that incorporate both photobiomodulation and photodynamic tissue management.
142 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.
This study's planned enrollment of 60 is above the median of 39 across 101 interventional studies indexed under Lichen Planus, Oral.
Browse Lichen Planus, Oral studies →Medical University of Silesia is the lead sponsor of 115 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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)
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 1 week after completion of assigned treatment
Change in lesion size measured in mm²
Lesion surface area will be measured using transparent millimeter-grid foil applied to the mucosal surface. Boundaries of each lesion will be traced and the total area calculated. Changes from baseline will be compared across treatment groups.
Time frame: Baseline, 1 week, 1 month, and 3 months after treatment completion
Change in pain intensity using the Visual Analogue Scale (VAS)
Pain will be assessed using a 0-10 VAS scale. Participants will report pain at baseline and at follow-up visits. Improvement will be quantified using the protocol-defined formula for pain reduction (NB).
Time frame: Baseline, 1 week, 1 month, and 3 months after treatment completion
Change in swelling or oral discomfort (subjective assessment)
Participants will evaluate swelling or discomfort on a 0-10 numeric scale. Improvement will be calculated using the protocol-defined formula (NO) to quantify reduction of symptoms after treatment.
Time frame: Baseline, 1 week, 1 month, and 3 months after treatment completion
Change in clinical grade using the Thonprasom scale (0-5)
Clinical severity of oral lichen planus will be evaluated using the Thonprasom grading system. Each lesion will be assigned a grade based on extent and morphology. Change in score over time will be used to assess therapeutic response.
Time frame: Baseline, 1 week, 1 month, and 3 months after treatment completion
Change in mycological status of oral mucosa
Oral swabs will undergo mycological analysis to detect presence of Candida species before and after treatment. Results will identify whether any intervention increases or reduces fungal colonization or secondary infection risk.
Time frame: Baseline and 1 week after treatment completion
Plan to share: No — Individual participant data will not be shared because the study involves sensitive clinical information and the protocol does not include provisions for external data distribution. Data access is limited to the research team to protect participant privacy and confidentiality.
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Studies of the drug tested here: Topical Corticosteroid
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