Comparative Study Between the Effect of Isotretinoin, Silymarin and Their Combination in the Treatment of Patients With Acne Vulgaris
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
- 否
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
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
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
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
Ghada mohamed abdelmonem mohamed Tantawy
Principle investigator
Tanta University
