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临床试验/NCT05666765
NCT05666765尚未招募4 期

Comparative Study Between the Effect of Isotretinoin, Silymarin and Their Combination in the Treatment of Patients With Acne Vulgaris

Tanta University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年1月1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
尚未招募
入组人数
75
试验地点
1
主要终点
Global Acne Grading Classification

研究概览

简要总结

This study aims to compare the effects of isotretinoin and silymarin or both in treatment of acne and their effects on the level of IGF-1, SAA1 and malondialdehyde (MDA) in acne patients.

详细描述

Acne vulgaris, a common and chronic disorder of the pilosebaceous unit, affects up to 85% of adolescent and young adults. The pathogenesis of acne is multifactorial. Traditionally, four distinct processes were believed to play critical roles: increased sebum production, alteration of keratinization processes leading to comedone formation, follicular colonization by Propionibacterium acnes (P.acnes) and inflammatory mediators around pilosebaceous unit.

Orally administered isotretinoin is currently the only agent that can affect all four main factors implicated in acne.

Serum insulin-like growth factor -1(IGF)-1 is a polypeptide hormone that has effects on sebocyte differentiation and proliferation. It leads to lipogenesis, and synthesis of inflammatory cytokines. IGF-1 also stimulates androgen synthesis leading to overproduction of sebum.

Propionibacterium acnes can increase the release of serum amyloid A1 (SAA1) .There is significant elevation of SAA1 in patients with acne, with a positive correlation with its severity.

Oxidative stress plays a role in the pathogenesis of acne in part due to the generation of reactive oxygen species (ROS) in response to infection by the bacterium Propionibacterium acnes, which colonizes the skin and grows in plugged hair follicles, thus attracting inflammatory cells, mainly neutrophils. These in turn secrete inflammatory mediators and generate ROS, which augments the inflammatory response and tissue damage.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 16 years or more. Patient with moderate or severe acne. Not receiving acne treatment in the last month.

排除标准

  • Pregnancy or lactation. Patients with known hypersensitivity to isotretinoin or silymarin. Patients with depression, liver diseases or high cholesterol. Patients with acromegaly. Patients with chronic inflammatory, infective or neoplastic disorders.

研究组 & 干预措施

acne vulgaris patients group 1

Experimental

acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both)

干预措施: Isotretinoin ,silymarin (Drug)

acne vulgaris patients group 2

Experimental

acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both)

干预措施: Isotretinoin ,silymarin (Drug)

acne vulgaris patients group 3

Experimental

acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both)

干预措施: Isotretinoin ,silymarin (Drug)

结局指标

主要结局

Global Acne Grading Classification

时间窗: 3 months

Global Acne Grading System (GAGS) Each is derived by multiplying the factors-2 for forehead, 2 for each check, 1 for nose, 1 for chin, 3 for both chest and back by the most heavily weighted lesion within each region (1 for ≥ one comedone, 2 for ≥ one papule,3 for ≥ one pustule, and 4 for ≥ one nodule).

次要结局

  • Liver function tests(3 months)
  • Lipid profile(3 months)
  • Insulin growth factor -1(3 months)
  • serum amyloid A1(3 months)
  • Malondialdehyde(3 months)

研究者

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

Ghada mohamed abdelmonem mohamed Tantawy

Principle investigator

Tanta University

研究点 (1)

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