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NCT Number: NCT07536737

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Bialystok

Bialystok, Podlaskie Voivodeship, 15-089, Poland

About this study

Oral lichen planus (OLP) is a chronic inflammatory disease of the oral mucosa that is 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 effects of different therapeutic approaches on taste perception and salivary biomarkers of oxidative, nitrosative, and carbonyl stress remain insufficiently investigated.

The aim of this randomized clinical trial is to evaluate and compare the effects of 5-aminolevulinic acid-based photodynamic therapy (ALA-PDT) and topical corticosteroid therapy (CT) on gustatory function, clinical outcomes, and selected salivary biomarkers 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, sour, salty, and bitter taste perception, with scores ranging from 0 to 4 for each taste modality and a total taste score ranging from 0 to 16. Taste perception is evaluated before treatment initiation and immediately after completion of therapy.

Salivary concentrations of cortisol, malondialdehyde (MDA), advanced oxidation protein products (AOPP), peroxynitrite, nitrotyrosine (NT), and advanced glycation end products (AGEs) are assessed before treatment, immediately after therapy completion, and at 3, 6, and 12 months following each therapeutic intervention. These measurements are intended to evaluate longitudinal changes in psychological stress and oxidative, nitrosative, and carbonyl stress associated with OLP and its treatment.

Additional clinical outcomes include changes in lesion size and subjective symptom severity assessed using a 10-point Visual Analog Scale (VAS).

This study aims to provide evidence on the comparative effectiveness of ALA-PDT and topical corticosteroid therapy in modulating taste perception, clinical manifestations, and salivary stress-related biomarkers in patients with OLP. The findings may contribute to a better understanding of the biological effects of both therapeutic approaches and support evidence-based treatment decision-making.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in taste function

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

    Change in gustatory function assessed using Taste Strips, including identification of sweet, sour, salty, and bitter tastes, and total taste score.

Secondary outcomes

  1. Change in lesion size

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

    Change in oral lesion surface area (cm²) measured clinically between baseline and post-treatment.

  2. Change in pain intensity (VAS)

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

    Change in patient-reported pain intensity assessed using a 10-point (0-10) Visual Analog Scale (VAS) from baseline to post-treatment.

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

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

    Salivary concentrations of cortisol, malondialdehyde (MDA), advanced oxidation protein products (AOPP), peroxynitrite, nitrotyrosine (NT), and advanced glycation end products (AGEs) will be measured to assess changes in stress-related responses and oxidative, nitrosative, and carbonyl damage associated with oral lichen planus and its treatment.

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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