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临床试验/NCT05529888
NCT05529888已完成4 期

Serum Homocysteine Level in Acne Patients Before and After Oral Isotretinoin

Aswan University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年12月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Evaluation of the effect of oral isotretinoin on Serum homocysteine in acne vulgaris patients

研究概览

简要总结

Serum homocysteine level in Acne patients before and after oral Isotretinoin and Correlation between serum level of homocysteine in acne patients before and after Oral isotretinoin treatment

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 homocysteine level in acne patient befor and after oral isotrtinoin 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 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both sexes with acne vulgaris

排除标准

  • Patients with history of malignancies.
  • Patients with renal and hepatic dysfunction.
  • Cardiac patient.
  • Pregnant, lactating and female welling to have pregnancy in the period of study.
  • Patient with absorption disorder.
  • Patient with history of favism.
  • Patient has already been treated with isotretinoin.

研究组 & 干预措施

Patient group

Active Comparator

Patients were treated with Isotretinoin in a dose (from 20 to 40) for 3 months and serum homocysteine were 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 Serum homocysteine in acne vulgaris patients

时间窗: 3 months

Assessment in serum level homocysteine level in acne vulgaris patients after isotretinoin therapy with assesment of its level before starting therapy for detecting changes in serum homocysteine and effect of isotretinoin therapy on it.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Doaa Hamdi Abd Elal Mohamed

Principal Investigator

Aswan University

研究点 (1)

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