Peking University Third Hospital
Beijing, China
Location status: Recruiting
Location contact
Lin Zeng
CONTACT
Recruiting
NCT Number: NCT05973097
Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
total glucosides of paeony treatment
DrugTotal glucosides of paeony capsules were given 0.6 g once, 3 times a day.
photodynamic therapy treatment
OtherCover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.
glucosides of paeony and photodynamic therapy combined treatment
OtherGlucosides of paeony and photodynamic therapy are combined for the treatment
Primary outcomes
-
Efficacy at 1 month of treatment
Time frame: 1 month
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.
Secondary outcomes
-
The curative effect at the later follow-up visit
Time frame: through study completion, an average of 1 year
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Peking University Third Hospital
Other
Registry information
Official study title
Clinical Study of Combined Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy
Important dates
- Study start
- 2023
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Aug 2, 2023
- Registry last updated
- Aug 2, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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