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Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy

Primary Purpose

Oral Lichen Planus

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
total glucosides of paeony treatment
photodynamic therapy treatment
glucosides of paeony and photodynamic therapy combined treatment
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus focused on measuring oral lichen planus, integrated Chinese and Western medicine, total glucosides of paeony, photodynamic therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

total glucosides of paeony treatment

photodynamic therapy treatment

glucosides of paeony and photodynamic therapy combined treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 15, 2023
Last Updated
July 25, 2023
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05973097
Brief Title
Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy
Official Title
Clinical Study of Combined Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2023 (Anticipated)
Primary Completion Date
December 30, 2028 (Anticipated)
Study Completion Date
December 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
Keywords
oral lichen planus, integrated Chinese and Western medicine, total glucosides of paeony, photodynamic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
total glucosides of paeony treatment
Arm Type
Active Comparator
Arm Description
Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.
Arm Title
photodynamic therapy treatment
Arm Type
Active Comparator
Arm Description
Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.
Arm Title
glucosides of paeony and photodynamic therapy combined treatment
Arm Type
Experimental
Arm Description
Glucosides of paeony and photodynamic therapy are combined for the treatment
Intervention Type
Drug
Intervention Name(s)
total glucosides of paeony treatment
Intervention Description
Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.
Intervention Type
Other
Intervention Name(s)
photodynamic therapy treatment
Intervention Description
Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.
Intervention Type
Other
Intervention Name(s)
glucosides of paeony and photodynamic therapy combined treatment
Intervention Description
Glucosides of paeony and photodynamic therapy are combined for the treatment
Primary Outcome Measure Information:
Title
Efficacy at 1 month of treatment
Description
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
Secondary Outcome Measure Information:
Title
The curative effect at the later follow-up visit
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihui Zhang, Dr.
Phone
010-82266125
Email
wisdomzhangzhihui@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Zeng
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihui Zhang
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Zeng

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12969224
Citation
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.
Results Reference
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PubMed Identifier
21453765
Citation
Li 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.
Results Reference
background
PubMed Identifier
32220595
Citation
Villa 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.
Results Reference
background
PubMed Identifier
31478283
Citation
Lavaee 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.
Results Reference
background
PubMed Identifier
27129091
Citation
Zhou 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.
Results Reference
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Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy

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