Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05716152 |
| Other study ID # |
Soh-Med-22-11-07 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2023 |
| Est. completion date |
August 1, 2024 |
Study information
| Verified date |
February 2023 |
| Source |
Sohag University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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.
