NCT07536737

Impact of PDT and Topical Corticosteroids on Taste Perception in Patients With OLP

Impact of Photodynamic Therapy and Topical Corticosteroids on Taste Perception in Patients With Oral Lichen Planus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Medical University of Bialystok · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Oral Lichen Planus

Interventions

Type	Name	Description
DRUG	5-Amino Levulinic Acid	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.
DRUG	Clobetasol Propionate 0.05% Cream	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.

Timeline

• Start date: 2021-09-30
• Primary completion: 2023-01-10
• Completion: 2023-07-10
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Poland