Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05973097

Clinical Study of Combined Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy

Led by Peking University Third Hospital · Updated on 2023-08-02

156

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Oral lichen planus (OLP) is a common chronic inflammatory condition affecting the mouth's lining, often causing white patches that can worsen to painful erosions. It is considered a precancerous condition caused by an autoimmune reaction involving T-lymphocytes. Currently, treatments only address symptoms, and no cure exists. This research aims to evaluate the combined effect of paeoniflorin, a traditional Chinese medicine compound, and photodynamic therapy for treating OLP. Participants will be randomly assigned to one of three treatment groups: daily capsules of total glucosides of paeony at 0.6 grams three times a day; photodynamic therapy involving applying a photosensitizer to lesions followed by laser diode treatment; or a combination of both treatments. This trial will assess whether combining these therapies improves outcomes compared to each alone. During the study, participants will be monitored for treatment effectiveness after one month and followed up for about a year to observe longer-term effects. Researchers will measure improvements in OLP symptoms and track safety. The study involves signing informed consent and includes evaluations of oral lesions and overall health throughout participation, which may last up to a year.

CONDITIONS

Brief Title

Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with oral lichen planus
  • Male or female patients aged 18 years or older
  • Patients willing to participate and able to provide signed informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Patients with serious heart, lung, liver, kidney diseases, or tumors
  • Patients unwilling to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 month

Participants receive treatment with total glucosides of paeony capsules, photodynamic therapy, or a combination of both for oral lichen planus.

Regular visits during the 1 month treatment period

Follow-up

Duration - Up to 1 year after treatment

Participants are assessed for curative effect through study completion, approximately 1 year after treatment.

Follow-up visits depending on participant progress

Trial Site Locations

Total: 1 location

1

Peking University Third Hospital

Beijing, China

Actively Recruiting

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Research Team

Z

Zhihui Zhang, Dr.

L

Lin Zeng

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Lack of clinicopathologic correlation in the diagnosis of oral lichen planus based on the presently available diagnostic criteria and suggestions for modifications.

E H van der Meij, I van der Waal

https://pubmed.ncbi.nlm.nih.gov/12969224

Clinical observation on the treatment of oral lichen planus with total glucosides of paeony capsule combined with corticosteroids.

Leilei Zhou, Tianyi Cao, Yufeng Wang...

https://pubmed.ncbi.nlm.nih.gov/27129091