Oral Lichen PlanusNCT07910175
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
A study testing Nano- Curcumin-Mediated Photodynamic Therapy (PDT) and Photobiomodulation Therapy (PBM) in people with Oral Lichen Planus, run by Alexandria University at 1 site in Egypt.
Trial summary
Background: Oral Lichen Planus (OLP) is a chronic, T-cell-mediated inflammatory disease of the oral mucosa, with the erosive form causing painful ulcerations and erosions, significantly impacting the patient's quality of life and carrying a risk of malignant transformation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Nano- Curcumin-Mediated Photodynamic Therapy (PDT) and Photobiomodulation Therapy (PBM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2026to 15 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed clinically and histopathologically with erosive oral lichen planus without dysplastic features based on WHO criteria
- Patients diagnosed with oral erosive lichen planus refractory to conventional treatment
- Patients complaining of painful lesions with pain threshold at a minimum value of 4 on a standard Numerical Rating Scale (NRS)
- Therapeutic Washout: Absolute suspension of all localized or systemic corticosteroid / immunosuppressive regimens for at least 4 weeks prior to structural baseline evaluations
Who cannot join
- Pregnant or lactating females due to lack of standard safety parameters.
- Presence of secondary concurrent multi-system autoimmune pathologies.
- Lichenoid reactions: Lesions exhibiting definitive spatial localization to dental amalgam margins or secondary to active drug induction.
- Diagnosed systemic photosensitivity syndromes or secondary utilization of systemic photosensitizing therapeutic agents.
- Smokers
- Bad oral hygiene , severe periodontal disease
- Underlying systemic diseases like diabetes , hypertension , cardiac patients , pace makers
- Patients with extra oral manifestations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria
Faculty of Dentistry, (203) 4868308
Ahmed Eldifrawi, BDS
About this study
Official title: Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus (a Randomized Clinical Trial)
Background: Oral Lichen Planus (OLP) is a chronic, T-cell-mediated inflammatory disease of the oral mucosa, with the erosive form causing painful ulcerations and erosions, significantly impacting the patient's quality of life and carrying a risk of malignant transformation. While corticosteroids remain the first-line treatment, their long-term use is limited by significant local and systemic side effects. Consequently, there is a critical need for effective, non-invasive and safe alternative therapies. Photodynamic Therapy (PDT) and Photobiomodulation (PBM) have emerged as promising light-based modalities. Curcumin, a natural polyphenol, has gained attention as a safe and effective photosensitizer for PDT due to its anti-inflammatory and antioxidant properties.
Aim: This clinical trial aims to evaluate and compare the effect of nano-curcumin formulation incorporated into biodegradable mucoadhesive gel as a photosensitizer for Photodynamic Therapy (PDT) versus Photobiomodulation (PBM) in the treatment of oral erosive lichen planus.
- Conditions
- Oral Lichen Planus
- Being tested
- Nano- Curcumin-Mediated Photodynamic Therapy (PDT), Photobiomodulation Therapy (PBM)
- 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.
Nano- Curcumin-Mediated Photodynamic Therapy (PDT)Other
A standardized 1% nano-curcumin loaded biodegradable mucoadhesive gel will then be applied over the erosive lesion and its peripheral margins. Treatment will be administered twice weekly for four consecutive weeks, resulting in a total of eight treatment sessions per patient
Photobiomodulation Therapy (PBM)Other
Utilization of a Blue laser 445 nm for 45-60 seconds per spot in non-contact mode, then application of red laser 660nm Diode Laser \ for 5-10 seconds per spot in non-contact mode. For blue laser Output configuration is at 100 mW and for Red laser output configuration is at 100 mW. Each patient will receive 2 sessions per week (a total of 8 sessions)
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Other: Nano- Curcumin-Mediated Photodynamic Therapy (PDT) |
| Control Group | Active comparator | Not described Receives: Other: Photobiomodulation Therapy (PBM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in lesion size
Objective lesion size resolution using Thongprasom scale at baseline, 1, 2, 3, 4, 12 weeks
Measured: up to 12 weeks
change in pain scores
Subjective Pain score as measured by Numerical Rating Scale (NRS) at baseline, 1,2,3,4,12 weeks
Measured: up to 12 weeks
Secondary outcomes (2)
change in quality of life
Quality of Life using OHIP-14 Questionnaire at baseline, 4, 12 weeks
Measured: up to12 weeks
change in Salivary oxidative stress marker
Salivary oxidative stress marker using MDA salivary kits at baseline, 4 and 12 weeks
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start30 Sep 2026 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
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.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910175
- Sponsor's protocol ID
- 1369-07/2026
- Status last verified
- Sep 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus (a Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07910175
- Acronym / sponsor ID
- 1369-07/2026
- Conditions
- Oral Lichen Planus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 2 Nov 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.
Background: Oral Lichen Planus (OLP) is a chronic, T-cell-mediated inflammatory disease of the oral mucosa, with the erosive form causing painful ulcerations and erosions, significantly impacting the patient's quality of life and carrying a risk of malignant transformation. While corticosteroids remain the first-line treatment, their long-term use is limited by significant local and systemic side effects. Consequently, there is a critical need for effective, non-invasive and safe alternative therapies. Photodynamic Therapy (PDT) and Photobiomodulation (PBM) have emerged as promising light-based modalities. Curcumin, a natural polyphenol, has gained attention as a safe and effective photosensitizer for PDT due to its anti-inflammatory and antioxidant properties.
Aim: This clinical trial aims to evaluate and compare the effect of nano-curcumin formulation incorporated into biodegradable mucoadhesive gel as a photosensitizer for Photodynamic Therapy (PDT) versus Photobiomodulation (PBM) in the treatment of oral erosive lichen planus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Other: Nano- Curcumin-Mediated Photodynamic Therapy (PDT) |
| Control Group | Active comparator | Other: Photobiomodulation Therapy (PBM) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed clinically and histopathologically with erosive oral lichen planus without dysplastic features based on WHO criteria
- Patients diagnosed with oral erosive lichen planus refractory to conventional treatment
- Patients complaining of painful lesions with pain threshold at a minimum value of 4 on a standard Numerical Rating Scale (NRS)
- Therapeutic Washout: Absolute suspension of all localized or systemic corticosteroid / immunosuppressive regimens for at least 4 weeks prior to structural baseline evaluations
Key exclusion criteria (8 listed)
- Pregnant or lactating females due to lack of standard safety parameters.
- Presence of secondary concurrent multi-system autoimmune pathologies.
- Lichenoid reactions: Lesions exhibiting definitive spatial localization to dental amalgam margins or secondary to active drug induction.
- Diagnosed systemic photosensitivity syndromes or secondary utilization of systemic photosensitizing therapeutic agents.
- Smokers
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 |
|---|---|---|
| Nano- Curcumin-Mediated Photodynamic Therapy (PDT)A standardized 1% nano-curcumin loaded biodegradable mucoadhesive gel will then be applied over the erosive lesion and its peripheral margins. Treatment will be administered twice weekly for four consecutive weeks, resulting in a total of eight treatment sessions per patient | Other | Test Group |
| Photobiomodulation Therapy (PBM)Utilization of a Blue laser 445 nm for 45-60 seconds per spot in non-contact mode, then application of red laser 660nm Diode Laser \ for 5-10 seconds per spot in non-contact mode. For blue laser Output configuration is at 100 mW and for Red laser output configuration is at 100 mW. Each patient will receive 2 sessions per week (a total of 8 sessions) | Other | Control Group |
Primary outcome
change in lesion size
Time frame: up to 12 weeks
Objective lesion size resolution using Thongprasom scale at baseline, 1, 2, 3, 4, 12 weeks
change in pain scores
Time frame: up to 12 weeks
Subjective Pain score as measured by Numerical Rating Scale (NRS) at baseline, 1,2,3,4,12 weeks
2 secondary outcomes
change in quality of life
Time frame: up to12 weeks
change in Salivary oxidative stress marker
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
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Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nano- Curcumin-Mediated Photodynamic Therapy (PDT) and Photobiomodulation Therapy (PBM) in people with Oral Lichen Planus, run by Alexandria University at 1 site in Egypt.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 2 Nov 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Eldifrawi, BDS (01229766196 ext. 002, ahmedeldifrawii@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in lesion size (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. 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 2 Nov 2026.