Oral Lichen PlanusNCT07536737
Impact of PDT and Topical Corticosteroids on Taste Perception and Salivary Oxidative Stress Markers in Patients With OLP
A study testing 5-Amino Levulinic Acid and Clobetasol Propionate 0.05% Cream in people with Oral Lichen Planus, run by Medical University of Bialystok at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- 5-Amino Levulinic Acid and Clobetasol Propionate 0.05% Cream
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 sitePoland
- Study dates
- 30 Sep 2021to 10 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older
- clinically and histologically confirmed diagnosis of oral lichen planus
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Bialystok
Bialystok, Podlaskie Voivodeship, 15-089
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Oral Lichen Planus
- Being tested
- 5-Amino Levulinic Acid, Clobetasol Propionate 0.05% Cream
- Keywords
- pdt, corticosteroids, taste perception, olp, nitrosative stress, oxidative stress, carbonyl stress
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Amino Levulinic AcidDrug
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% CreamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Clobetasol Propionate 0.05% Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) and after treatment (Day 14 for CT group and Day 35 for PDT group)
Secondary outcomes (3)
Change in lesion size
Change in oral lesion surface area (cm²) measured clinically between baseline and post-treatment.
Measured: Baseline (Day 1) and after treatment (Day 14 for CT group and Day 35 for PDT group)
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.
Measured: 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
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.
Measured: Measurements will be performed before treatment, immediately after therapy completion, and at 3, 6, and 12 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start30 Sep 2021
- Primary completion10 Jan 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Sulewska, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536737
- Sponsor's protocol ID
- APK.002.372.2021
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of PDT and Topical Corticosteroids on Taste Perception and Salivary Oxidative Stress Markers in Patients With OLP
- ClinicalTrials.gov ID
- NCT07536737
- Acronym / sponsor ID
- APK.002.372.2021
- Conditions
- Oral Lichen Planus
- Keywords
- pdt, corticosteroids, taste perception, olp, nitrosative stress, oxidative stress, carbonyl stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy | Experimental | Drug: 5-Amino Levulinic AcidPatients 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 | Drug: Clobetasol Propionate 0.05% CreamPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 years or older
- clinically and histologically confirmed diagnosis of oral lichen planus
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-Amino Levulinic AcidA 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 | Photodynamic therapy |
| Clobetasol Propionate 0.05% CreamClobetasol 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. | Drug | Corticosteroid therapy |
Primary outcome
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.
3 secondary outcomes
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 pain intensity (VAS)
Time frame: 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
Time frame: Measurements will be performed before treatment, immediately after therapy completion, and at 3, 6, and 12 months after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-Amino Levulinic Acid and Clobetasol Propionate 0.05% Cream in people with Oral Lichen Planus, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in taste function (time frame: Baseline (Day 1) and after treatment (Day 14 for CT group and Day 35 for PDT group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.