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临床试验/NCT06242288
NCT06242288已完成3 期

Correlation Between Depression Scores and Serum NF-ĸB/NLRP3 Axis, Biotinidase, and HMGB After Treatment With Isotretinoin in Patients With Acne Vulgaris

Mostafa Bahaa1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
change in biotinidase level

研究概览

简要总结

Acne is a chronic inflammatory disease of the pilosebaceous unit resulting from androgen-induced increased sebum production, altered keratinization, inflammation, and bacterial colonization of hair follicles on the face, neck, chest, and back by, Cutibacterium acnes. Although all age groups can be affected, it is primarily a disease of adolescence. Treatment selection is based on disease severity, patient preference, and tolerability. Isotretinoin is drug of chioce used for moderate and severe acne. Isotretinoin results in a significant reduction in sebum production, influences comedogenesis, lowers surface and ductal c. acnes and has anti-inflammatory properties. Biotin deficiency may be caused by insufficient dietary uptake of biotin, drug- vitamin interactions and increased biotin catabolism during pregnancy and in smokers. Biotin deficiency can also be precipitated by decreased activities of biotinidase, which plays a central role in the intestinal absorption of biotin

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age of 19 to 35 years. Body mass index (BMI) of 18.5 to 23 kg/m
  • Acne vulgaris (global acne scoring more than 18)

排除标准

  • Use of oral steroids, oral contraceptives, oral vitamin A derivatives, antibiotics, or herbal medicines that may affect the test results during the last 4 weeks.
  • Alcohol drinking within the last week. Smoking. Pregnancy or lactation. Judgement that physical or mental testing is not appropriate for the clinical trial.
  • Participation in other clinical trials that may affect this t

研究组 & 干预措施

Comparative group

Active Comparator

20 acne patients taking isotretinoin 20 mg once daily

干预措施: ISOtretinoin 20 MG (Drug)

结局指标

主要结局

change in biotinidase level

时间窗: 2 months

change in biotinidase level

次要结局

未报告次要终点

研究者

发起方
Mostafa Bahaa
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mostafa Bahaa

Teaching assisstant

Tanta University

研究点 (1)

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