Effect of Systemic Isotretinoin on Serum Irisin Level in Acne Vulgaris Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evalaute serum level of irisin in acne patient
研究概览
简要总结
Acne vulgaris is a chronic inflammatory skin disease affecting the pilosebaceous unit. It is clinically characterized by comedones, papules, pustules, nodules, cysts and scarring on the face and trunk.
The severity of the disease ranges from mild comedonal acne to severe nodulocystic acne which can be permanently disfiguring.In addition to the physical lesions, the disease can have a profound psychologic impact, contributing to low self-esteem, depression and anxiety.In addition to the physical lesions, the disease can have a profound psychologic impact, contributing to low self-esteem, depression and anxiety.
详细描述
The prevalence of self-reported acne and clinically confirmed acne was 34.69% and 24.39%, respectively. Females reported acne more frequently than males did (39.13% ).The prevalence of clinically confirmed acne was higher among females (28.64%) than males .
Its pathogenesis results from androgen-induced increased sebum production, altered keratinization, inflammation of infundibular epithelium and bacterial colonisation of hair follicles by Propionibacterium acne
There are several treatment modalities for acne vulgaris including topical like topical antibiotics, topical benzoyl peroxide, topical azelaic acid and topical retinoids. Systemic therapy like antibiotics, hormonal therapy and isotretinoin .
Adipokines may have a role in the pathogenesis of acne vulgaris and are associated with acne severity. Irisin, a hormone -like myokine, is one of the adipokines with anti- inflammatory and anti-oxidant effects
There is limited evidence for physical modalities (e.g., laser therapy, light therapy, chemical peels) and complementary therapies (e.g., purified bee venom, low-glycemic-load diet, tea tree oil) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cases with moderate and severe acne.
- •Clinical diagnosis of acne Disease
- •Patient not receive any treatment for acne vulgaris at least six months duration.
排除标准
- •1 Pregnant and lactating women.
- •History of chronic liver disease .
- •Cardiovascular disorders .
- •Renal disease .
- •Hyperlipidemia .
- •Depression or mental illness.
- •Insulin dependent diabetes 8 Thyroid disease. 9 Osteoporosis or low bone mineral density . 10 Intestinal disorders such as inflammatory bowel disease or ulcerative colitis
研究组 & 干预措施
Pateints with Moderate Acne
20 patients affected by Acne and More than half of the face is involved. Many papules and pustules, many open or closed comedones. One nodule may be present.
干预措施: Isotretinoin (Drug)
Pateints with Severe Acne
20 patients affected by Acne and Entire face is involved, covered with many papules and pustules, open or closed comedones and rare nodules
干预措施: Isotretinoin (Drug)
control
20 Health participants
干预措施: Isotretinoin (Drug)
结局指标
主要结局
Evalaute serum level of irisin in acne patient
时间窗: From 0 base to 3 Months from starting the treatment Day
Assessment of clinical improvement according to:(8) G4(excellent:100% reduction) G3(good:75-99% reduction) G2(moderate: 50-74% reduction) G1(insufficient :1-49% reduction) G0(unchanged) G-1(worse)
次要结局
- Evalaute the effect of treatment with systemic isotretinon(From 0 base to 3 Months from starting the treatment Day)
研究者
Nahed Mohammed Abou Elwfa
Resident
South Valley University