Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Derming SRL
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change from baseline of the hair density
研究概览
简要总结
Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the activity on hair regrowth of a topical cosmetic product versus placebo (comparison within subjects)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers
- •female sex
- •with hypertrichosis
- •agreeing not to perform epilation or scrub/peeling treatment on the test area (legs) during the week preceding the inclusion
- •good general state of health
排除标准
- •pregnancy
- •lactation
- •subjects whose insufficient adhesion to the study protocol is foreseeable
- •sensitive skin
- •oral contraceptive therapy started less than 1 year
- •presence of varicose or capillary veins of surface
- •hormonal therapies able to influence hair growth.
- •presence of cutaneous disease on the tested area, as lesions, scars, malformations.
- •endocrine disease
- •hepatic disorder
- •renal disorder
- •cardiac disorder
- •farmacological topical treatment and surgery and/or medical treatment on the treated side performed in the last 3 months
- •systemic corticosteroids
- •aspirin or non-steroid anti-inflammatory drugs (FANS)
- •diuretic.
研究组 & 干预措施
Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)
Comparison within subjects of Actapil Corpo Spray versus Placebo. The study product will be applied twice a dayon the right or left leg (tibialis area) according to a randomisation list.
The placebo product will be applied in the same way, on the controlateral leg.
干预措施: Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy) (Other)
Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)
Comparison within subjects of Actapil Corpo Spray versus Placebo. The study product will be applied twice a dayon the right or left leg (tibialis area) according to a randomisation list.
The placebo product will be applied in the same way, on the controlateral leg.
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline of the hair density
时间窗: Baseline (T0), 1 month (T1), 3 months (T3)
Hair density (hair number/mm2) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
Change from baseline of hair regrowth speed
时间窗: Baseline (T0), 1 month (T1), 3 months (T3)
Hair regrowth speed (mm/die) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
Change from baseline of the percentage of terminal hair
时间窗: Baseline (T0), 1 month (T1), 3 months (T3)
Percentage of terminal hair (terminal hair has a diameter \>0.04 mm) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
Change from baseline of the percentage of vellus hair
时间窗: Baseline (T0), 1 month (T1), 3 months (T3)
Percentage of vellus hair (terminal hair has a diameter \<0.04 mm) is calculate by Image-Pro Plus software on the microscopic images captured with Dino-Lite (AnMo Electronics Corporation,Taiwan)
次要结局
- Change from baseline of superficial skin hydration(Baseline (T0), 1 month (T1), 3 months (T3))
研究者
Adele Sparavigna
Dermatologist, Principal Investigator
Derming SRL