Assessment of Serum Testosterone and Tissue Androgen Receptors in Male Patients With Psoriasis Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 主要终点
- Blood sample.
研究概览
简要总结
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
详细描述
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.
- 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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
- •●Healthy male volunteers matched to the patient group for age and sex.
排除标准
- •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.
结局指标
主要结局
Blood sample.
时间窗: 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).
Skin biopsy
时间窗: 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
次要结局
未报告次要终点
研究者
Mahmoud Abdelhamed Mohamed
Principal Investigator & resident of dermatology in sohag general hospital,
Sohag University