Assessment Of Serum And Tissue Levels Of Cold-Inducible RNA-Binding Protein In Patients With Lichen Planus

NCT06260189 | Recruiting

• 1 other identifier: Soh-Med-24-01-02MD
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Lichen planus (LP) is a chronic inflammatory mucocutaneous disease of unknown etiology. Pathogenesis of LP is not completely understood, but it's considered a T-cell-mediated autoimmune disease. Cold-inducible RNA binding protein (CIRP or CIRBP) is a member of the glycine-rich RNA-binding protein family, Recent studies proved that CIRP acts as a tumor promoter through its actions on different cellular proliferation levels, Recently, the role of the damage associated molecular proteins and cytokines was highlighted in the pathogenesis of many disorders including psoriasis, alopecia areata, vitiligo, rheumatoid arthritis, other autoimmune diseases as well as several types of cancer. The aim of this study is to compare serum and tissue levels of CIRP in patients with LP and healthy controls.

Conditions

Assessment, Self

Keywords

Lichen Planus, Cold-inducible RNA-binding protein

Outcome Measures

Primary Outcomes (1)

• Assessment of cold-inducible RNA binding protein levels in serum and tissue

  Skin biopsies and blood samples will be taken to assess CIRBP levels

  about one year

Study Arms (2)

Lichen Planus Cases

40 cases with lichen planus from who skin biopsies and blood samples will be taken to assess cold inducible RNA binding protein levels in both tissues and serum.

Healthy control group

40 healthy controls from who skin biopsies and blood samples will be taken to assess serum and tissue levels of cold-inducible RNA binding protein and compare them to active cases.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

40 patients with LP and 40 age and gender matched healthy controls who will attend the Dermatology Outpatient Clinics, Sohag University Hospitals. Diagnosis of LP will be clinically and will be confirmed by dermoscopy.

You may qualify if:

• Patients from both sexes aged 18 - 60 years, having clinical and dermoscopic confirmed LP and did not receive any topical or systemic treatment in the last 3 months for LP.

You may not qualify if:

• Pregnancy and lactation. 2. Patients with any infections or sepsis. 3. Patients with any other dermatological diseases associated with increased CIRP levels (eg. psoriasis, vitiligo or alopecia areata).
• \. Patients with systemic illness (cardiac, renal, hepatic or respiratory), malignancy, with history of connective tissue diseases or on immunosuppressive treatment.
• \. Patients who received any topical or systemic treatment for LP 3 months before the study.
• \. Patients with oral, nail or scalp LP.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Aya Ahmed Elsayed

Sohag, 82511, Egypt

RECRUITING

MeSH Terms

Conditions

Lichen Planus

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mohammed A Abu El-Hamd, MD

  Sohag University

  STUDY CHAIR

• Soha H Aboeldahab, MD

  Sohag University

  STUDY DIRECTOR

• Rasha I Mohamed, MD

  Sohag University

  STUDY DIRECTOR

Central Study Contacts

Aya A Elsayed, Msc

CONTACT

00201060094631; aya_shando@yahoo.com

Aya A Alshandawely, Msc

CONTACT

00201061691091; aya_shando@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aya Ahmed Elsayed

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

EG (1)