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

NCT07536737 | Completed

• 1 other identifier: APK.002.372.2021
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pdt; corticosteroids; taste perception; olp; nitrosative stress; oxidative stress; carbonyl stress

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Change in lesion size

  Baseline (Day 1) and after treatment (Day 14 for CT group and Day 35 for PDT group)

• Change in pain intensity (VAS)

  Baseline (Day 1) and after treatment (Day 14 for CT group and Day 35 for PDT group)

• Change in salivary biomarkers of stress and oxidative, nitrosative, and carbonyl damage

  Measurements will be performed before treatment, immediately after therapy completion, and at 3, 6, and 12 months after treatment.

Study Arms (2)

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.

Drug: 5-Amino Levulinic Acid

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.

Drug: Clobetasol Propionate 0.05% Cream

Interventions

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.

Photodynamic therapy

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.

Corticosteroid therapy

Eligibility Criteria

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

You may qualify if:

• age 18 years or older
• clinically and histologically confirmed diagnosis of oral lichen planus

You may not qualify if:

• pregnancy or lactation presence of systemic diseases, including dermatologic diseases, oncologic diseases, or severe liver disorders known allergies use of immunomodulatory or immunosuppressive drugs use of antidepressants use of bone anti-metabolites photosensitivity allergy to the components of the photosensitizer treatment for oral lichen planus within the previous 6 months inability to attend follow-up visits presence of oral lesions other than oral lichen planus

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (1)

Medical University of Bialystok

Bialystok, Podlaskie Voivodeship, 15-089, Poland

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Aminolevulinic Acid; Clobetasol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 17, 2026
• Study Start: September 30, 2021
• Primary Completion: January 10, 2023
• Study Completion: July 10, 2023
• Last Updated: July 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)