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Oral lichen planus (OLP) is a chronic inflammatory disease that affects the lining of the mouth and may cause pain, burning sensations, and discomfort. Some patients also report changes in their ability to taste different flavors.
The aim of this study is to compare two commonly used treatments for OLP: photodynamic therapy (PDT) and topical corticosteroids. PDT is a light-based treatment that uses a special gel applied to the affected areas, followed by illumination with a medical light device. Topical corticosteroids are anti-inflammatory medications applied directly to the lesions.
Participants in this study are randomly assigned to receive one of these two treatments. Before starting therapy and immediately after its completion, patients undergo a simple taste test using special strips that assess the ability to recognize sweet, sour, salty, and bitter tastes. In addition, the size of oral lesions and the intensity of symptoms such as pain or burning are evaluated.
The results of this study may help to better understand how different treatments for oral lichen planus affect taste perception and overall patient well-being, and may support the selection of the most appropriate therapy in clinical practice.
Oral lichen planus (OLP) is a chronic inflammatory disease of the oral mucosa, frequently associated with pain, burning sensations, and impaired quality of life. Alterations in gustatory function have also been reported in patients with OLP; however, the impact of different therapeutic approaches on taste perception remains insufficiently investigated.
The aim of this randomized clinical trial is to evaluate and compare the effects of ALA (5-aminolevulonic acid) -based photodynamic therapy (PDT) and topical corticosteroid therapy (CT) on gustatory function in patients with clinically and histologically confirmed OLP.
Participants are randomly allocated to one of two parallel treatment groups: (1) ALA-PDT using a 5% 5-aminolevulinic acid mucoadhesive emulgel followed by irradiation with a 630 nm LED light source, administered in five weekly sessions; or (2) topical corticosteroid therapy with clobetasol propionate applied twice daily for two weeks.
Gustatory function is assessed using standardized taste strips, evaluating sweet(0-4), sour(0-4), salty(0-4), and bitter (0-4) taste perception, as well as total taste score (0-16), before treatment initiation and immediately after therapy completion. Secondary outcomes include changes in lesion size and subjective symptom severity assessed using the Visual Analog Scale (VAS) (0-10).
This study aims to provide evidence on the comparative effectiveness of PDT and topical corticosteroids in modulating taste perception and clinical outcomes in patients with OLP, thereby supporting evidence-based therapeutic decision-making.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photodynamic therapy | Experimental | Patients with clinically and histologically confirmed oral lichen planus receive photodynamic therapy using a proprietary 5% 5-aminolevulinic acid (ALA) mucoadhesive emulgel (patent P.443813, Poland). After drying the oral mucosa, a 2 mm layer of the ALA emulgel is applied to the lesion and surrounding tissue twice, 40 and 20 minutes prior to irradiation. The treated area is covered with an occlusive dressing secured with gauze. Irradiation is performed using a FotoSan® 630 LED lamp (CMS Dental, Denmark) with a wavelength of 630 nm for 6 minutes per cm² of lesion area. The treatment consists of five sessions conducted at weekly intervals. Gustatory function is assessed using standardized taste strips before the initiation of therapy and immediately after completion of the treatment. |
|
| Corticosteroid therapy | Active Comparator | Patients with clinically and histologically confirmed oral lichen planus receive topical corticosteroid therapy with clobetasol propionate cream (0.5 mg/g; Bausch Health, Poland). The medication is applied directly to the lesions twice daily for a period of two weeks, in accordance with standard clinical practice. Gustatory function is assessed using standardized taste strips before the initiation of therapy and immediately after completion of the treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Amino Levulinic Acid | Drug | A 5% 5-aminolevulinic acid (ALA) mucoadhesive formulation is applied topically to oral lichen planus lesions. The preparation is administered twice (40 and 20 minutes prior to light irradiation) under occlusive conditions to enhance tissue penetration. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in taste function | Change in gustatory function assessed using Taste Strips, including identification of sweet, sour, salty, and bitter tastes, and total taste score. | Baseline (Day 1) and after treatment (Day 14 for CT group and Day 35 for PDT group) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity (VAS) | Change in patient-reported pain intensity assessed using a 10-point (0-10) Visual Analog Scale (VAS) from baseline to post-treatment. | Baseline (Day 1) and after treatment (Day 14 for CT group and Day 35 for PDT group) |
| Change in lesion size |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Bialystok | Bialystok | Podlaskie Voivodeship | 15-089 | Poland |
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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| D002990 | Clobetasol |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Outcome assessors and laboratory personnel were blinded to group allocation. Due to the nature of the interventions (photodynamic therapy with 5-aminolevulonic acid (ALA-PDT) vs topical corticosteroids (CT)), participants and treating clinicians were not blinded.
|
| Clobetasol Propionate 0.05% Cream | Drug | Clobetasol propionate 0.05% (Clobederm) is applied topically to oral lichen planus lesions twice daily for a period of 5 weeks, according to standard clinical practice. |
|
Change in oral lesion surface area (cm²) measured clinically between baseline and post-treatment. |
| Baseline (Day 1) and after treatment (Day 14 for CT group and Day 35 for PDT group) |
| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |