An interventional study of Nano- Curcumin-Mediated Photodynamic Therapy (PDT) and Photobiomodulation Therapy (PBM) in Oral Lichen Planus, sponsored by Alexandria University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
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.
145 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.
This study's planned enrollment of 42 is above the median of 36 across 103 interventional studies indexed under Lichen Planus, Oral.
Browse Lichen Planus, Oral studies →Alexandria University is the lead sponsor of 596 studies on the registry; 134 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Other: Nano- Curcumin-Mediated Photodynamic Therapy (PDT)
Other: Photobiomodulation Therapy (PBM)
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
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)
change in lesion size
Objective lesion size resolution using Thongprasom scale at baseline, 1, 2, 3, 4, 12 weeks
Time frame: 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
Time frame: up to 12 weeks
change in quality of life
Quality of Life using OHIP-14 Questionnaire at baseline, 4, 12 weeks
Time frame: up to12 weeks
change in Salivary oxidative stress marker
Salivary oxidative stress marker using MDA salivary kits at baseline, 4 and 12 weeks
Time frame: up to 12 weeks
Start is estimated for Sep 2026; primary completion for May 2027, 7 months later.
Of 19 interventional studies with no phase under Lichen Planus, Oral, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 29. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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