Placebo-controlled, Parallel, Randomized (1:1), Double-blind Study Over 6 Months to Evaluate the Efficacy and Safety of the Food Supplement Olistic Women.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Increase in hair density
研究概览
简要总结
Hair loss is a multifactorial and complex condition influenced by factors such as hormonal changes, vitamin and mineral deficiencies, genetic predisposition, oxidative stress, aging, inflammation, and psychological stress. This 6-month randomized, double-blind, placebo-controlled study aimed to evaluate the efficacy and safety of a drinkable nutraceutical formulated with natural, high-quality, patented, and standardized ingredients designed to support hair health through multiple biological pathways. A total of 106 premenopausal women aged 18 to 40 years and diagnosed with telogen effluvium were randomized to receive either the nutraceutical (n = 53) or placebo (n = 53). The primary endpoint was the increase in hair density from baseline versus placebo. The secondary endpoint was the change in the anagen-to-catagen/telogen (A:C/T) ratio. These parameters were assessed using phototrichoscopy and phototrichogram via TrichoScan®. The study was approved by an ethics committee and conducted by two independent board-certified dermatologists at two study sites.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18-40 years
- •Sex: female
- •Telogen effluvium diagnosis with hair loss > 100 hairs, confirmed using validated "modified wash test"
- •Otherwise, healthy volunteers
- •Refraining from systemic, topical, oral products with similar effects to the active product
- •Signed informed consent
- •Maintenance of daily cosmetic and dietary routine
- •Availability to attend all visits
- •Compliance with all protocol requirements
排除标准
- •Previous use of active product
- •Participation in similar studies or usage of anti-hair loss products within the last 3 months
- •History of dermatological treatment (e.g. mesotherapy) and/or hair transplant
- •Skin or scalp diseases (e.g. psoriasis, dermatitis, alopecias)
- •Alopecia secondary to medical diseases (e.g. hypothyroidism, anemia)
- •Ongoing treatment for or diagnosis of systemic disease
- •Hormonal treatment (oral or topical contraceptives) within 6 months prior to study start
- •Known allergy or intolerance, including to any of the ingredients of the active product
- •Pregnancy, post-partum (6 months) or breastfeeding
结局指标
主要结局
Increase in hair density
时间窗: From enrollment to the end of treatment at 180 days.
From phototrichogram on the temporoparietal area of the scalp.
次要结局
- Change in the Anagen-to-Catagen/Telogen ratio(From enrollment to the end of treatment at 180 days.)