Randomized Double-Blind Case Control Study of Safety and Efficacy of Skin Cleanser Contained Hibiscus Sabdariffa Extract in Acne Treatment.
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- 1. Safety evaluation: Patch test 2. Efficacy evaluation: Acne lesions counts/ acne severity grading
研究概览
简要总结
Skin cleanser for daily used is essential and one of the most common questions asked by acne patients. There are studies reported beneficial effects of cleansers in acne treatment. Extracts of plants as active ingredients in skin cleansers are increasingly popular worldwide. Roselle is a common tropical shrub. Usually, the calyces of the plant have been used to make beverages but it also used in Thai traditional medicine for several purposes including as antiseptic and astringent. The extract of roselle showed antioxidant and keratolytic effects from previous studies which fit to the pathogenesis of acne. The aims of the study is to determine the safety and efficacy of skin cleanser contained roselle extract in acne.
详细描述
Acne is one of the most common skin problems in teenagers and adolescents. Keys pathogenesis of the disease are 1.abnormal hypercornification of pilosebaceous duct,2.excess sebum production, 3.inflammation, 4.the present of Propionibacterium acnes. Treatments often include combination of topical and oral medications according to degree of acne severities. Acne medications can lead to drying and irritation of skin. Proper skin cleansing is important and can improve tolerability and efficacy of acne treatment.
Traditional medicine with longstanding used of herbal ingredients for skin problems and beauty is increasing more popular. Hibiscus sabdariffa L.(Roselle) is used as food, drink and topical formulation for skin infection in Thai traditional medicine. The extract from calyces contained polyphenolic compounds and anthocyanins that showed antioxidant and keratolytic activities. There for skin cleanser with Roselle extract might be benefit to acne by loosen comedone, reduce Propionibacterium acne and prevent keratinocyte injury.
The purposes of this study is to evaluate skin cleanser contained Roselle extract in two aspects ; 1. safety for irritation and allergic effects, 2. efficacy in acne as cleanser alone and as supportive care with others acne therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 12-45 yrs,both sex
- •clinical diagnosis of mild to moderately severe acne vulgaris(grade 1-3)
- •have at least 10 facial acne lesions
- •not changing any acne treatment during study period
- •able to follow up according to protocol
- •Written informed consent
排除标准
- •pregnant or breast feeding
- •severe acne(grade4 or nodulocystic acne)
- •treated with isotretinoin orally during the last 3 months
- •have other systemic disease or illness
- •have allergic history to Roselle
结局指标
主要结局
1. Safety evaluation: Patch test 2. Efficacy evaluation: Acne lesions counts/ acne severity grading
时间窗: 6 weeks
次要结局
- 1. Safety evaluation: "a." Skin properties by visual and tactile features., "b." Biophysical parameters of skin. 2.Efficacy evaluation: Patient assessments.(6 weeks)