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临床试验/NCT01687556
NCT01687556已完成不适用

Epigallocatechin-3-Gallate Improves Acne in Humans by Modulating Intracellular Molecular Targets and Inhibiting P. Acnes

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2005年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Assessment of acne severity

研究概览

简要总结

Epigallocatechin-3-gallate (EGCG) may improve acne vulgaris

  • major polyphenolic constituent in green tea
  • known as potent anti-carcinogenic, anti-inflammatory, anti-proliferative, and antimicrobial activities
  • lipid-lowering and antiandrogenic properties was reported
  • EGCG can improve acne vulgaris via one of the above mentioned actions.

详细描述

Acne vulgaris is one of the most prevalent skin disorders of sebaceous follicles, affecting more than 85% of adolescents in United States. Acne can persist throughout the adulthood, and even a mild form of acne might progress to permanent scarring on the face, chest and back, thereby causing significant physical and psychosocial morbidities. Acne is a multifactorial disease of which etiology has not been fully elucidated, although considerable progress has been made in understanding its pathogenesis during last decade. The major pathogenic features of acne include abnormal ductal keratinization, sebum overproduction, Propionibacterium acnes, and inflammation. Common acne medications such as topical retinoids, antibiotics and isotretinoin are associated with irritation and incomplete responses, increased bacterial resistance or untoward side events, respectively. Thus there is a continuing need for a novel, effective agent targeting different aspects of acne pathogenesis, with minimal side effects.

In the recent decade, epigallocatechin-3-gallate (EGCG), the major polyphenolic constituent in green tea, has attracted much interest on account of its potent anti-carcinogenic, anti-inflammatory, anti-proliferative, and antimicrobial activities. Preclinical, observational, and clinical trial data have indicated that EGCG can inhibit tumor initiation, promotion, progression, and angiogenesis. EGCG also suppresses neutrophil chemotaxis, and has been suggested to improve many diseases that have inflammatory components such as diabetes, kidney injuries, arthritis, allergies, dental caries, cardiovascular, gastrointestinal, and neurodegenerative diseases. In skin, EGCG has been investigated mainly in light of antioxidative, immunopotentiating and anticarcinogenic properties against chemicals or ultraviolet irradiation. Moreover, EGCG has lipid-lowering and antiandrogenic properties, and can downregulate peroxisome proliferator-activated receptor-γ expression. Based on these observations, it can be inferred that EGCG might be effective in the treatment of acne.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • age of at least 15 years
  • clinical diagnosis of mild to moderate acne vulgaris

排除标准

  • known pregnancy or lactation
  • any medical illness that might influence the results of the study,
  • a previous history of oral acne medication or surgical procedures including laser treatment within 6 month and topical medication within 4 weeks of study enrollment.

结局指标

主要结局

Assessment of acne severity

时间窗: 8 week after baseline

Lesion counts of non-inflammatory lesions (closed comedone, open comedone) and severity measured by Reeds revised scale

次要结局

  • 2-mm punch biopsy of acne lesion on the EGCG-treated sides(8 week after baseline)
  • Standardized clinical photographs(8 week after baseline)

研究者

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

Dae Hun Suh

Professor

Seoul National University Hospital

研究点 (2)

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