Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy

NCT ID: NCT05973097

Last Updated: 2023-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-30

Study Completion Date

2028-12-30

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.

Conditions

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Oral Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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total glucosides of paeony treatment

Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.

Group Type ACTIVE_COMPARATOR

total glucosides of paeony treatment

Intervention Type DRUG

Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.

photodynamic therapy treatment

Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.

Group Type ACTIVE_COMPARATOR

photodynamic therapy treatment

Intervention Type OTHER

Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.

glucosides of paeony and photodynamic therapy combined treatment

Glucosides of paeony and photodynamic therapy are combined for the treatment

Group Type EXPERIMENTAL

glucosides of paeony and photodynamic therapy combined treatment

Intervention Type OTHER

Glucosides of paeony and photodynamic therapy are combined for the treatment

Interventions

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total glucosides of paeony treatment

Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.

Intervention Type DRUG

photodynamic therapy treatment

Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.

Intervention Type OTHER

glucosides of paeony and photodynamic therapy combined treatment

Glucosides of paeony and photodynamic therapy are combined for the treatment

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhihui Zhang

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhihui Zhang, Dr.

Role: CONTACT

010-82266125

Lin Zeng

Role: CONTACT

Facility Contacts

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Lin Zeng

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 12969224 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21453765 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32220595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31478283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27129091 (View on PubMed)

Other Identifiers

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PUTHM912068

Identifier Type: -

Identifier Source: org_study_id

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