Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy
Clinical Study of Combined Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy
1 other identifier
interventional
156
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2023
CompletedStudy Start
First participant enrolled
July 30, 2023
CompletedFirst Posted
Study publicly available on registry
August 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2028
August 2, 2023
July 1, 2023
5.4 years
July 15, 2023
July 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The curative effect at the later follow-up visit
through study completion, an average of 1 year
Study Arms (3)
total glucosides of paeony treatment
ACTIVE COMPARATORTotal glucosides of paeony capsules were given 0.6 g once, 3 times a day.
photodynamic therapy treatment
ACTIVE COMPARATORCover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.
glucosides of paeony and photodynamic therapy combined treatment
EXPERIMENTALGlucosides of paeony and photodynamic therapy are combined for the treatment
Interventions
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
Eligibility Criteria
You may qualify if:
- patients with oral lichen planus
- male or female patients older than 18 years of age
- patients willing to participate with signed informed consent.
You may not qualify if:
- pregnant or lactating
- had serious systemic diseases of the heart, lung, liver, and kidney, or had tumors
- were unwilling to participate in the experiment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital
Beijing, China
Related Publications (5)
van der Meij EH, van der Waal I. Lack of clinicopathologic correlation in the diagnosis of oral lichen planus based on the presently available diagnostic criteria and suggestions for modifications. J Oral Pathol Med. 2003 Oct;32(9):507-12. doi: 10.1034/j.1600-0714.2003.00125.x.
PMID: 12969224BACKGROUNDLi J, Chen CX, Shen YH. Effects of total glucosides from paeony (Paeonia lactiflora Pall) roots on experimental atherosclerosis in rats. J Ethnopharmacol. 2011 May 17;135(2):469-75. doi: 10.1016/j.jep.2011.03.045. Epub 2011 Mar 29.
PMID: 21453765BACKGROUNDVilla A, Sankar V, Bassani G, Johnson LB, Sroussi H. Dexamethasone solution and dexamethasone in Mucolox for the treatment of oral lichen planus: a preliminary study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Jun;129(6):585-590. doi: 10.1016/j.oooo.2020.02.014. Epub 2020 Mar 25.
PMID: 32220595BACKGROUNDLavaee F, Shadmanpour M. Comparison of the effect of photodynamic therapy and topical corticosteroid on oral lichen planus lesions. Oral Dis. 2019 Nov;25(8):1954-1963. doi: 10.1111/odi.13188. Epub 2019 Oct 2.
PMID: 31478283BACKGROUNDZhou L, Cao T, Wang Y, Yao H, Du G, Tian Z, Tang G. Clinical observation on the treatment of oral lichen planus with total glucosides of paeony capsule combined with corticosteroids. Int Immunopharmacol. 2016 Jul;36:106-110. doi: 10.1016/j.intimp.2016.03.035. Epub 2016 Apr 26.
PMID: 27129091BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhihui Zhang
Peking University Third Hospital
Central Study Contacts
Lin Zeng
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2023
First Posted
August 2, 2023
Study Start
July 30, 2023
Primary Completion (Estimated)
December 30, 2028
Study Completion (Estimated)
December 30, 2028
Last Updated
August 2, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share