Hormonal Associations in Male Patients With Psoriasis Vulgaris

February 3, 2023 updated by: Mahmoud Abdelhamed Mohamed, Sohag University

Assessment of Serum Testosterone and Tissue Androgen Receptors in Male Patients With Psoriasis Vulgaris

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective cross sectional clinical study will be conducted on (51) male patients with clinically diagnosed psoriasis vulgaris seeking medical advice at Dermatology outpatient clinics, Sohag University Hospital, Sohag. Age matched healthy adults (51) will be recruited as a control group. The study design will be approved by the ethical and scientific research committee of Sohag University. An informed consent will be obtained from all patients. Dignosis of psoriasis will be confirmed by Dermoscopy.

  1. Initial evaluation:

    History taking of patients will include personal history, special habits, and drug treatment. General examination will include weight, height, BMI, and blood pressure.

  2. Dermatological evaluation:

    The Psoriasis Area Severity Index (PASI) will be used for patients' evaluation as it is currently the most popular tool in clinical studies. It is a measure of the average redness, thickness and scales of the lesions (each graded on a 0-4 scale), weighed by the area of involvement. The final result of this method of assessment ranges from (0.0 to 72.0). Severity of plaque psoriasis will be graded to mild (PASI ≤10) and moderate to severe (>10). Only patients with moderate to severe plaques psoriasis will be included.

  3. Hormonal assessment:

    3-1- Androgen deficiency screening: The Arabic version of the Aging Male Symptoms (AMS) score will be used for Androgen deficiency screening . The AMS questionnaire includes 17 questions which are scored from 1 to 5 for each. It has 3 dimensions, i.e. psychological, somatic, and sexual subscale. The total score is the sum of the three-dimension scores which ranges from 17 to 85. The total AMS score is defined as 'no/little' (17-26 points), 'mild' (27-36 points), 'moderate' (37-49 points), and 'severe' (≥50 points). 3-2- Hormonal laboratory investigations: 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).

  4. Other laboratory investigations:

    4-1- Lipid profile assessment: Blood sample will be taken after overnight fasting (12-14 hours) to assess triglyceride, total cholesterol, High-density lipoprotein (HDL), and Low-density lipoprotein (LDL). 4-2- C-Reactive protein (CRP): as a marker of chronic inflammation.

  5. 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.

Sample size calculation:

Sample size calculation was carried out using G*Power 3 software. A calculated minimum sample of 102 participants in 1:1 design (51 male patients with psoriasis vulgaris as cases and 51 age matched control) will be needed to detect an effect size of 0.5 in the mean level of total testosterone and AR expression, with an error probability of 0.05 and 80% power on a two-tailed test.

Study Type

Observational

Enrollment (Anticipated)

102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Psoriasis vulgaris participants
Diagnostic test: Morning blood sample and skin punch biopsy of 4 mm diameter.
  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
not diseased participants
Diagnostic test: Morning blood sample and skin punch biopsy of 4 mm diameter.
  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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood sample.
Time Frame: 1.5 year
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
Time Frame: 1.5 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2023

Primary Completion (ANTICIPATED)

February 28, 2024

Study Completion (ANTICIPATED)

August 1, 2024

Study Registration Dates

First Submitted

January 14, 2023

First Submitted That Met QC Criteria

February 3, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-11-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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