CClinicalTrials.gg
Status unknownNCT05997173Updated Aug 18, 2023

The Regulatory Role of Immune Response in Oral Lichen Planus

An observational study in Oral Lichen Planus, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-18.

Sponsored by Peking University Third Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
90
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Oral Lichen Planus

Keywords

  • oral lichen planus
  • depression
  • anxiety
  • mesenchymal stem cells
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In context

Lichen Planus, Oral

139 studies on the registry are indexed under Lichen Planus, Oral; 24 are open to participants now.

This study's planned enrollment of 90 is above the median of 78 across 35 observational studies indexed under Lichen Planus, Oral.

Browse Lichen Planus, Oral studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Participants with oral lichen planus or control Male or female patients older than 18 years of age Participants willing to participate with signed informed consent.

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

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.
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Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • Control

    Normal control group

    Other: Control

  • Non erosive OLP

    Non erosive oral lichen planus

    Other: Non erosive OLP

  • Erosive OLP

    Erosive oral lichen planus

    Other: Erosive OLP

Interventions

  • OtherControl

    Investigation of scale of control

  • OtherNon erosive OLP

    Investigation of cale of non erosive OLP patients

  • OtherErosive OLP

    Investigation of cale of erosive OLP patients

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: During the initial diagnosis,through study completion, an average of 1 year

Secondary outcomes

  1. 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.

    Time frame: During the initial diagnosis,through study completion, an average of 1 year

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Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, China
    • Lin Zeng · Contact
    • · Contact · 01082266872
    Recruiting
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References and documents

Publications

  • 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. PubMed 23901717 ↗
  • 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. PubMed 27349424 ↗
  • 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. PubMed 22305766 ↗
  • 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. PubMed 32871704 ↗
  • 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. PubMed 30993798 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05997173
Lead sponsor
Peking University Third Hospital
Responsible party
Sponsor
First posted
Aug 18, 2023
Start date
Sep 7, 2020
Primary completion
Feb 2025 (estimated)
Completion
Feb 2025 (estimated)
Last update
Aug 18, 2023

Study contacts

Zhihui Zhang
Contact
wisdomzhangzhihui@163.com
010-82266125
Lin Zeng
Contact
Zhihui Zhang
principal investigator · Peking University Third Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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