Hormonal Associations in Male Patients With Psoriasis Vulgaris

NCT05716152 | Unknown FDA Drug

• 1 other identifier: Soh-Med-22-11-07
• Study Type: observational
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

A cross sectional clinical study will be conducted on male patients with moderate and sever psoriasis vulgaris to:

• Identify the pattern of serum testosterone level and tissue androgen receptors.
• Evaluate the relationship between serum testosterone level, tissue androgen receptors and the severity of psoriasis vulgaris

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (2)

• Blood sample.

  Morning blood sample (8:00-10:00 am) will be obtained for assessment of Total Testosterone (TT), Free Testosterone (fT), Luteinizing hormone (LH), Follicle stimulating hormone (FSH), and Estradiol (E2).

  1.5 year

• Skin biopsy

  Skin punch biopsy of 4 mm diameter will be obtained from both psoriasis patients (from the lesional and non-lesional sites), and the control group (normal skin). Tissue specimens will be used for formation of Paraffin embedded blocks. Slides will be stained by routine Hematoxylin and Eosin stain. The expression of AR will be measured by immune and histochemical staining by the use of a mouse monoclonal antibody

  1.5 year

Study Arms (2)

Psoriasis vulgaris participants

Diagnostic Test: Morning blood sample and skin punch biopsy of 4 mm diameter.

not diseased participants

Diagnostic Test: Morning blood sample and skin punch biopsy of 4 mm diameter.

Interventions

Morning blood sample and skin punch biopsy of 4 mm diameter. DIAGNOSTIC_TEST

1. Morning blood sample (8:00-10:00 am) will be obtained for assessment of Total Testosterone (TT), Free Testosterone (fT), Luteinizing hormone (LH), Follicle stimulating hormone (FSH), and Estradiol (E2). 2. Skin biopsy: Skin punch biopsy of 4 mm diameter will be obtained from both psoriasis patients (from the lesional and non-lesional sites), and the control group (normal skin). Tissue specimens will be used for formation of Paraffin embedded blocks. Slides will be stained by routine Hematoxylin and Eosin stain. The expression of AR will be measured by immune and histochemical staining by the use of a mouse monoclonal antibody

Psoriasis vulgaris participants; not diseased participants

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Cases: ✔Male patients with clinically moderate to severe plaque psoriasis (PASI score \>10) for at least 1 year and age (18-55) years old. Control: ✔Healthy male volunteers matched to the patient group for age and sex.

You may qualify if:

• Cases:
• Male patients with plaque psoriasis.
• With clinically moderate to severe plaque psoriasis (PASI score \>10).
• For at least 1 year.
• Age (18-55) years old.
• Control:
• ●Healthy male volunteers matched to the patient group for age and sex.

You may not qualify if:

• Other clinical varieties of psoriasis.
• History of diabetes mellitus.
• History of advanced renal or hepatic disease.
• History of genital disorders, or hormonal impalance.
• Current use of hormonal therapy, lipid-reducing drugs, and/or gluco- corticosteroid.

Sponsors & Collaborators

• Sohag University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator & resident of dermatology in sohag general hospital,

Study Record Dates

• First Submitted: January 14, 2023
• First Posted: February 8, 2023
• Study Start: February 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: August 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share