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Impact of PDT and Topical Corticosteroids on Taste Perception and Salivary Oxidative Stress Markers in Patients With OLP

NCT07536737 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-07-14

No results posted yet for this study

Summary

Oral lichen planus (OLP) is a long-term inflammatory disease affecting the lining of the mouth. It may cause pain, burning sensations, discomfort, and changes in the appearance of the oral mucosa. Some patients may also notice changes in their ability to recognize different tastes.

The aim of this study is to compare two treatments used for OLP: photodynamic therapy (PDT) and topical corticosteroid therapy. PDT is a light-based treatment in which a special gel containing 5-aminolevulinic acid is applied to the affected areas and then activated using a medical light device. Topical corticosteroids are anti-inflammatory medicines applied directly to the oral lesions.

Participants are randomly assigned to receive one of these two treatments. Their ability to recognize sweet, sour, salty, and bitter tastes is assessed using special taste strips before treatment and immediately after therapy is completed. The size of the oral lesions and the severity of symptoms, such as pain and burning, are also evaluated.

Saliva samples are collected before treatment, immediately after treatment, and 3, 6, and 12 months after therapy. These samples are used to measure cortisol and several substances related to inflammation and cellular stress, including malondialdehyde, advanced oxidation protein products, peroxynitrite, nitrotyrosine, and advanced glycation end products.

The results may help researchers better understand how photodynamic therapy and topical corticosteroids affect taste perception, oral symptoms, lesion healing, and biological changes in the saliva of patients with OLP. The findings may also support the selection of the most appropriate treatment in clinical practice.

Conditions

  • Oral Lichen Planus

Interventions

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.

Sponsors & Collaborators

  • Medical University of Bialystok

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2023-01-10
Completion
2023-07-10

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07536737 on ClinicalTrials.gov