Comparison of Clinical and Histological Effects Between Lactobacillus Fermented Chamaecypris Obtusa and Tea Tree Oil for the Treatment of Mild to Moderate Acne: an 8-week Double Blind, Randomized Controlled, Split-face Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Number of inflammatory and non-inflammatory acne lesions
研究概览
简要总结
In an 8 week double blind randomized controlled split-face studies, we tried to compare the clinical efficacy, safety and histopathological changes between Lactobacillus fermented Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO)
Basically, this is a split face study - one side of face randomly assigned was applied with LFCO and the other side with TTO in same patients.
详细描述
Screening of natural compounds for the development of anti-acne therapeutic agents has been steadily required considering various side effects of acne medications.However, previous studies have mainly focused on experimental tests without clinical trials and histopathological analysis.
To compare the clinical efficacy, safety and histopathological changes between Lactobacillus fermented Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO)
Total thirty four patients were instructed to apply 5 % LFCO to the involved areas of randomly allocated side and 5 % TTO extract to the other side for 8 weeks in a double blind split-face clinical trial.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 19-45
- •active acne lesions in both sides of face
- •available during study periods
排除标准
- •pregnancy, mental illness, intake of oral isotretinoin within 6 months, application of the other oral or topical acne medications, chemical peeling or light based treatments within 6 weeks.
结局指标
主要结局
Number of inflammatory and non-inflammatory acne lesions
时间窗: total 8 weeks after baseline
Compared to baseline, number inflammatory and non-inflammatory acne lesions were counted to check out the effectiveness \& safety of two botanical compounds
次要结局
- Patient's subjective assessments for comfortableness & efficacy(8 weeks after baseline)
- Sebum secretion assessment(8 weeks after baseline)
- Histopathologic analysis(8 weeks after baseline)
- Adverse effects(8 weeks after baseline)
研究者
Dae Hun Suh
Professor
Seoul National University Hospital