NCT03878238已完成不适用
Randomized, Double Blind and Placebo-controlled Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne Vulgaris
Bionou Research, S.L.2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年7月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change from baseline in GAGS (Global Acne Grading System) index score at 12 weeks
研究概览
简要总结
A 12-week randomized, double-blind, placebo-controlled pilot study to evaluate the effect of a probiotic blend in the treatment and clinical and subjective evolution of acne vulgaris in adolescent and adult patients between 12 and 30 years.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signature of informed consent by the patient (and their legal guardian in case of being under age).
- •Age between 12 and 30 years-old.
- •Moderate acne according to the AGSS (Acne Global Severity Scale) and / or GAGS (Global Acne Grading System) scales.
排除标准
- •Contraindication of any of the components of the product under study.
- •Topical or systemic use of antifungals and antibiotics in the previous 2 weeks.
- •Consumption of probiotics in the previous 2 months.
- •Use of systemic retinoids in the previous 6 months.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Probiotic
Experimental
干预措施: Probiotic Bths-003 (Dietary Supplement)
结局指标
主要结局
Change from baseline in GAGS (Global Acne Grading System) index score at 12 weeks
时间窗: 12-week
TOTAL SCORE = Nose S x 1 + Chin S x 1 + Front S x 2 + Right cheek S x 2 + Left cheek S x 2 + Torso S x 3 \[Severity (S): 0 = Absence; 1 = Comedones; 2 = Papules; 3 = Pustules; 4 = Nodules\] SCORE: 0 = Clean; 1-18 = Mild; 19-30 = Moderate; 31-38 = Severe; \> 38 = Very severe
次要结局
- Number of acne lesions(0, 6 and 12-week)
- Adherence to treatment(12-week)
- Patient subjective evaluation(0, 6 and 12-week)
- Treatment safety assessed by number of adverse events(12-week)
- AGSS (Acne Global Severity Scale) index score(0, 6 and 12-week)
研究者
研究点 (2)
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