Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy

Study Overview
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Brief Summary
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Oral lichen planus (OLP) is a common chronic inflammatory disease of the oral mucosa and is considered a precancerous condition. It is characterized by white reticular changes in the oral mucosa, which can progress to erosions and cause pain in severe cases. The pathogenesis of OLP is still unclear, but it is believed to be a T-lymphocyte-mediated autoimmune disease. Currently, only symptomatic treatments are available, and there is no definitive cure. In this project, we plan to use TCM differentiation to categorize OLP patients and conduct a randomized controlled clinical trial to demonstrate the enhanced therapeutic effect of paeoniflorin combined with photodynamic therapy for OLP. The implementation of this project will provide new insights into the clinical management of OLP, improve our understanding of the treatment mechanisms, and have important theoretical and clinical implications.

Detailed Description
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Paeoniflorin, a compound extracted from the traditional Chinese medicine, has anti-inflammatory and immunomodulatory effects. Photodynamic therapy is a novel local treatment approach, where photosensitizers selectively target and destroy diseased cells. Both treatments have shown efficacy in treating OLP when used individually.

Official Title
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Clinical Study of Combined Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy

Conditions
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Oral Lichen Planus

Intervention / Treatment
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* Drug: total glucosides of paeony treatment
* Other: photodynamic therapy treatment
* Other: glucosides of paeony and photodynamic therapy combined treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with oral lichen planus male or female patients older than 18 years of age patients willing to participate with signed informed consent. Exclusion Criteria: pregnant or lactating had serious systemic diseases of the heart, lung, liver, and kidney, or had tumors were unwilling to participate in the experiment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: total glucosides of paeony treatment<br>Total glucosides of paeony capsules were given 0.6 g once, 3 times a day. | Drug: total glucosides of paeony treatment<br>* Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.<br>|
| Active Comparator: photodynamic therapy treatment<br>Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode. | Other: photodynamic therapy treatment<br>* Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.<br>|
| Experimental: glucosides of paeony and photodynamic therapy combined treatment<br>Glucosides of paeony and photodynamic therapy are combined for the treatment | Other: glucosides of paeony and photodynamic therapy combined treatment<br>* Glucosides of paeony and photodynamic therapy are combined for the treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy at 1 month of treatment | According to the trial standard for evaluating the efficacy of atrophic and erosive oral lichen planus (OLP), the evaluation includes both objective and subjective measures. Objective measure: The size of the lesion is measured by an observer. The physician records and takes photographs of the lesion, noting the location, color, and changes in the area. The color and area changes of the lesion are compared and determined based on the photographic records. Subjective measure: Visual analogue scales (VAS) are used, which consist of 10 levels. The pain level is recorded, and the assessment is done by the patient. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The curative effect at the later follow-up visit | According to the trial standard for evaluating the efficacy of atrophic and erosive oral lichen planus (OLP), the evaluation includes both objective and subjective measures. Objective measure: The size of the lesion is measured by an observer. The physician records and takes photographs of the lesion, noting the location, color, and changes in the area. The color and area changes of the lesion are compared and determined based on the photographic records. Subjective measure: Visual analogue scales (VAS) are used, which consist of 10 levels. The pain level is recorded, and the assessment is done by the patient. | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral lichen planus, integrated Chinese and Western medicine, total glucosides of paeony, photodynamic therapy