Evaluation of The Effect of Oral Isotretinoin on The Level of Serum YKL40 in Acne Vulgaris Patients
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients.
研究概览
简要总结
The aim of the study is to evaluate the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients.
详细描述
Acne vulgaris is a common chronic inflammatory disease of the skin. It is found in about 80% of young adults and adolescents. It is a disease that affects the pilosebaceous units of the skin and may result in inflammatory or non-inflammatory lesions,Oral isotretinoin (13-cis-retinoic acid) is the only drug that counteracts all the pathogenetic mechanisms that contribute to the development of acne .The standard dose of isotretinoin is 0.5 to 1 mg/kg per day for 4 months to a cumulative dose of 120-140 mg/kg is effective in the management of acne vulgaris The scope of our study is to detect serum YKL-40 level in acne patient before and after oral isotretinoin treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy persons of both sexes with moderate and severe acne.
- •Age above 14 years.
排除标准
- •Pregnant and lactating women, immunocompromised patients.
- •History of chronic liver disease, hyperlipidemia, non-inflammatory acne conditions, , history of neurologic disorders, history of neoplastic disorders, and history of cardiac disease.
- •History of systemic acne treatment for at least 4 weeks prior to inclusion and no topical treatments for at least 2 weeks.
- •Cases with known hypersensitivity reaction to isotretinoin.
研究组 & 干预措施
Isotretinoin group
Patients will be treated with Isotretinoin in a dose (from 20 to 40) for 3 months and serum YKL40 will be assessed before and after treatment
干预措施: Isotretinoin (Drug)
结局指标
主要结局
Evaluation of the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients.
时间窗: 3 months
Assessment in serum level YKL40 level in acne vulgaris patients after isotretinoin therapy with assesment of its level before starting therapy for detecting changes in serum YKL40 and effect of isotretinoin therapy on it.
次要结局
未报告次要终点
研究者
Alshimaa Abbas Mohamed Ebrahim
principal investigator
Aswan University