Oral Lichen PlanusNCT05973097
Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy
A study testing total glucosides of paeony treatment, photodynamic therapy treatment and glucosides of paeony and photodynamic therapy combined treatment in people with Oral Lichen Planus, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- total glucosides of paeony treatment, photodynamic therapy treatment and glucosides of paeony and photodynamic therapy combined treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2023to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with oral lichen planus
- male or female patients older than 18 years of age
- patients willing to participate with signed informed consent.
Who cannot join
- pregnant or lactating
- had serious systemic diseases of the heart, lung, liver, and kidney, or had tumors
- were unwilling to participate in the experiment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lin Zeng contact
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Lin Zeng
About this study
Official title: Clinical Study of Combined 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.
Read the 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.
- Conditions
- Oral Lichen Planus
- Being tested
- total glucosides of paeony treatment, photodynamic therapy treatment, glucosides of paeony and photodynamic therapy combined treatment
- Keywords
- oral lichen planus, integrated Chinese and Western medicine, total glucosides of paeony, photodynamic therapy
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total glucosides of paeony treatmentDrug
Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.
photodynamic therapy treatmentOther
Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.
glucosides of paeony and photodynamic therapy combined treatmentOther
Glucosides of paeony and photodynamic therapy are combined for the treatment
| Study group | Role | What they receive |
|---|---|---|
| total glucosides of paeony treatment | Active comparator | Total glucosides of paeony capsules were given 0.6 g once, 3 times a day. Receives: Drug: total glucosides of paeony treatment |
| photodynamic therapy treatment | Active comparator | Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode. Receives: Other: photodynamic therapy treatment |
| glucosides of paeony and photodynamic therapy combined treatment | Experimental | Glucosides of paeony and photodynamic therapy are combined for the treatment Receives: Other: glucosides of paeony and photodynamic therapy combined treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start30 Jul 2023 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhihui Zhang, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973097
- Sponsor's protocol ID
- PUTHM912068
- Status last verified
- Jul 2023
- First submitted
- 15 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12969224Li 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.
PubMed 21453765Villa 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.
PubMed 32220595Lavaee 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.
PubMed 31478283Zhou 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.
PubMed 27129091
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Combined Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy
- ClinicalTrials.gov ID
- NCT05973097
- Acronym / sponsor ID
- PUTHM912068
- Conditions
- Oral Lichen Planus
- Keywords
- oral lichen planus, integrated Chinese and Western medicine, total glucosides of paeony, photodynamic therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Jul 2023 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| total glucosides of paeony treatment | Active comparator | Drug: total glucosides of paeony treatmentTotal glucosides of paeony capsules were given 0.6 g once, 3 times a day. |
| photodynamic therapy treatment | Active comparator | Other: photodynamic therapy treatmentCover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode. |
| glucosides of paeony and photodynamic therapy combined treatment | Experimental | Other: glucosides of paeony and photodynamic therapy combined treatmentGlucosides of paeony and photodynamic therapy are combined for the treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with oral lichen planus
- male or female patients older than 18 years of age
- patients willing to participate with signed informed consent.
Key exclusion criteria (3 listed)
- pregnant or lactating
- had serious systemic diseases of the heart, lung, liver, and kidney, or had tumors
- were unwilling to participate in the experiment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total glucosides of paeony treatmentTotal glucosides of paeony capsules were given 0.6 g once, 3 times a day. | Drug | total glucosides of paeony treatment |
| photodynamic therapy treatmentCover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode. | Other | photodynamic therapy treatment |
| glucosides of paeony and photodynamic therapy combined treatmentGlucosides of paeony and photodynamic therapy are combined for the treatment | Other | glucosides of paeony and photodynamic therapy combined treatment |
Primary outcome
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.
1 secondary outcome
The curative effect at the later follow-up visit
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Background: PubMed 12969224van 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.
- Background: PubMed 21453765Li 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.
- Background: PubMed 32220595Villa 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.
- Background: PubMed 31478283Lavaee 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.
- Background: PubMed 27129091Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lin Zeng contact
Zhihui Zhang principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total glucosides of paeony treatment, photodynamic therapy treatment and glucosides of paeony and photodynamic therapy combined treatment in people with Oral Lichen Planus, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhihui Zhang, Dr. (010-82266125, wisdomzhangzhihui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy at 1 month of treatment (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05973097, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.