Testing of Hair Products Containing Probiotics
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Skin Microbiota
研究概览
简要总结
Previous studies on skin health with Lactic acid bacteria (LAB) have been published for many years, including prevention of skin diseases and improvement of skin conditions. In this clinical study, the investigators researched the benefit effects of heat-killed Lactobacillus paracasei shampoo on scalp and hair healthcare.
详细描述
To evaluate the safety and efficacy of hair products containing probiotics
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers between the ages of 20-70.
排除标准
- •Subjects are undergoing medical therapy for scalp, hair diseases or diabetes mellitus.
- •Subjects with cosmetics allergy.
- •Subjects had accepted the scalp surgery such as Follicular Unit Transpalnt, Follicular Unit Extraction in the past half year.
- •Subjects with pregnancy or breast-feeding.
研究组 & 干预措施
Placebo group
Shampoo base without probiotics inculding Aqua、Sodium Lauryl Ether Sulphate、Cocamidopropyl Betaine、Cocoamide DEA、Sodium、Polyquaternium-10 、Disodium EDTA、Acrylates Copolymer、Citric Acid、Phenoxyethanol、Fragrance.
干预措施: Placebo group (Combination Product)
Test group
Shampoo base with probiotics inculding Aqua、Sodium Lauryl Ether Sulphate、Cocamidopropyl Betaine、Cocoamide DEA、Sodium、Polyquaternium-10 、Disodium EDTA、Acrylates Copolymer、Citric Acid、Phenoxyethanol、Fragrance、Heat-killed Lactobacillus paracasei powders (5x10^8 cells/ g-shampoo).
干预措施: Test group Probiotic Shampoo (Combination Product)
结局指标
主要结局
Skin Microbiota
时间窗: Baseline, 4 weeks and 8 weeks
The changes of scalp microbiota will be evaluated by NGS or qPCR analysis at baseline and different timepoint post-intervention.
次要结局
- The scalp flakes (dandruff)(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks)
- The sebum on scalp(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks)
- Adverse Event(Baseline and 28 weeks)
- The hair density (hairs/scalp area)(Baseline, 4 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks)
- Single application closed patch epicutaneous test under occlusion(1 hour, 24 hours and 48 hour)
- Repeated application closed patch epicutaneous test under occlusion(Day 1, 2, 3, 4 and 5)