An interventional study of total glucosides of paeony treatment and photodynamic therapy treatment in Oral Lichen Planus, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-02.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
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.
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.
142 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.
This study's planned enrollment of 156 is above the median of 39 across 101 interventional studies indexed under Lichen Planus, Oral.
Browse Lichen Planus, Oral studies →Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.
Drug: total glucosides of paeony treatment
Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.
Other: photodynamic therapy treatment
Glucosides of paeony and photodynamic therapy are combined for the treatment
Other: glucosides of paeony and photodynamic therapy combined treatment
Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.
Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.
Glucosides of paeony and photodynamic therapy are combined for the treatment
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.
Time frame: 1 month
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.
Time frame: through study completion, an average of 1 year
Plan to share: No
Start is estimated for Jul 2023; primary completion for Dec 2028, 65 months later.
Of 20 interventional studies with no phase under Lichen Planus, Oral, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 27. This study's planned 65 months is above that.
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