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Measuring inflammatory markers in the saliva of patients with mouth lesions and skin with mouth lesions together related to lichen planus

Evaluation of salivary levels of interleukin-6 interleukin 1-beta and interferon-gamma in oral and mucocutaneous lichen planus patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN15211121
Enrollment
45
Registered
2025-05-21
Start date
2024-12-17
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral and mucocutaneous lichen planus Skin and Connective Tissue Diseases

Interventions

1. Assess salivary biomarkers in OLP and MCLP 2. Compare the levels of these biomarkers in the studied groups with healthy controls 3. Correlation of the salivary biomarkers with their clinical manife

Sponsors

University of Sulaimani
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who are thoroughly informed about the trial and willing to participate 2. Both sexes (male and female), and females not pregnant 3. Oral lichen planus (OLP) and mucocutaneous lichen planus (MCLP) will be clinically and histopathologically confirmed by a dermatologist 4. All the patients not receiving disease-modifying treatment for at least 1 month before the study like corticosteroids and immunosuppressive drugs

Exclusion criteria

Exclusion criteria: 1. Patients who refuse to participate 2. The study excluded patients with other diagnosed oral mucosal diseases and some systemic diseases, including hematological and infectious diseases, and patients with allergic conditions 3. Systemic diseases that induce lichenoid drug eruption like cardiovascular and endocrine diseases 4. Patients who had received topical or systemic treatment 1 month before the study 5. Newly diagnosed cases

Design outcomes

Primary

MeasureTime frame
Measured at a single timepoint: 1. Salivary levels of interleukin-6 (IL-6) measured using enzyme-linked immunosorbent assay (ELISA) 2. Salivary levels of interleukin 1-beta (IL-1ß) measured using enzyme-linked immunosorbent assay (ELISA) 3. Salivary levels of interferon-gamma (IFN-?) measured using enzyme-linked immunosorbent assay (ELISA) 4. Disease severity assessed using clinical scoring Lichen Planus Severity Scales: 4.1. For oral lichen planus (OLP): Thongprasom Clinical Score (0-5 scores) 4.2. For cutaneous lichen planus: Physician Global Assessment (PGA) 4.3. Visual Analog scale (VAS) for symptoms in both

Secondary

MeasureTime frame
1. Correlation between salivary cytokine levels and clinical manifestations of oral lichen planus assessed by statistical analysis of ELISA results and clinical scores at completion of data collection 2. Comparison of inflammatory marker profiles between oral-only lichen planus and mucocutaneous lichen planus using statistical analysis of cytokine levels at completion of data collection

Countries

Iraq

Contacts

Public ContactPardis Hama
pardis.hama@univsul.edu.iq+964 (0)7705496130

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026