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Hormonal Associations in Male Patients With Psoriasis Vulgaris

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 55 Years
Gender Male
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05716152
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Sohag University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis Vulgaris
Additional Details

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.

Arms & Interventions

Arms

: Psoriasis vulgaris participants

: not diseased participants

Interventions

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

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). 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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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