The Regulatory Role of Immune Response in Oral Lichen Planus

Oral Lichen Planus Clinical Trial

Official title:

The Regulatory Role of Immune Response in Oral Lichen Planus With Mental Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05997173
• Other study ID #: BMU81800920402
• Status: Recruiting
• Start date: September 7, 2020
• Est. completion date: February 2025

Study information

• Verified date: September 2022
• Source: Peking University Third Hospital
• Contact: Zhihui Zhang
• Phone: 010-82266125
• Email: wisdomzhangzhihui[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Oral lichen planus (OLP) is a common chronic inflammatory disease of Oral mucosa. The pathogenesis of OLP is not clear, and there is no effective method to cure it. In vitro, previous studies have shown that oral mucosal mesenchymal stem cell cells (MSCs) can secrete Ido, which is involved in the pathogenesis of OLP. It has been proved that mental disorders such as depression and anxiety play an important role in the pathogenesis and treatment of OLP. Mental stress factors can cause abnormal changes of inflammatory factors, leading to immune dysfunction, which is also one of the main causes of OLP. In this study, we integrated the advantages of stomatology, psychiatry, neurobiology and traditional Chinese medicine, focused on the clinical problems of mental disorders with oral mucosal comorbidity, and assessed the depressive and anxiety status of OLP patients, so as to improve the therapeutic effect of OLP.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Other:
• Control
Investigation of scale of control
• Non erosive OLP
Investigation of cale of non erosive OLP patients
• Erosive OLP
Investigation of cale of erosive OLP patients

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Alrashdan MS, Cirillo N, McCullough M. Oral lichen planus: a literature review and update. Arch Dermatol Res. 2016 Oct;308(8):539-51. doi: 10.1007/s00403-016-1667-2. Epub 2016 Jun 27. — View Citation

Hashmi AM, Butt Z, Umair M. Is depression an inflammatory condition? A review of available evidence. J Pak Med Assoc. 2013 Jul;63(7):899-906. — View Citation

Nitzan U, Carmeli G, Chalamish Y, Braw Y, Kirsch I, Shefet D, Krieger I, Mendlovic S, Bloch Y, Lichtenberg P. Open-Label placebo for the treatment of unipolar depression: Results from a randomized controlled trial. J Affect Disord. 2020 Nov 1;276:707-710. doi: 10.1016/j.jad.2020.07.077. Epub 2020 Jul 21. — View Citation

Thapar A, Collishaw S, Pine DS, Thapar AK. Depression in adolescence. Lancet. 2012 Mar 17;379(9820):1056-67. doi: 10.1016/S0140-6736(11)60871-4. Epub 2012 Feb 2. — View Citation

Vilar-Villanueva M, Gandara-Vila P, Blanco-Aguilera E, Otero-Rey EM, Rodriguez-Lado L, Garcia-Garcia A, Blanco-Carrion A. Psychological disorders and quality of life in oral lichen planus patients and a control group. Oral Dis. 2019 Sep;25(6):1645-1651. doi: 10.1111/odi.13106. Epub 2019 May 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The scores of the scale with the symptoms and signs of the disease	Psychological factors in OLP patients and normal controls were assessed using psychological scales such as the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD). Tissue and blood samples were collected during visits, and the concentrations of inflammatory factors in normal and lesion tissues were detected using immunofluorescence, flow cytometry, and enzyme-linked immunosorbent assay (ELISA). Statistical analysis was performed to determine the correlation between emotional disorders and inflammation in OLP patients, aiming to elucidate the underlying pathogenic mechanisms.	During the initial diagnosis,through study completion, an average of 1 year
Secondary	Immune inflammatory response	Psychological factors in OLP patients and normal controls were assessed using psychological scales such as the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD). Tissue and blood samples were collected during visits, and the concentrations of inflammatory factors in normal and lesion tissues were detected using immunofluorescence, flow cytometry, and enzyme-linked immunosorbent assay (ELISA). Statistical analysis was performed to determine the correlation between emotional disorders and inflammation in OLP patients, aiming to elucidate the underlying pathogenic mechanisms.	During the initial diagnosis,through study completion, an average of 1 year