Randomized, Comparative Study to Assess the Effects of Cosmetic Lotion on Telogen Effluvium in Women Compared to a Control Group
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- anagen to telogen ratio
研究概览
简要总结
Telogen effluvium (TE) is one of the most common causes of non-scarring diffuse hair loss, defined as global diminution of hair with no formation of areas completely bald.
Premature termination of anagen into catagen and telogen hair follicle is the main mechanism observed in TE. It results in increased, synchronized telogen shedding leading to a decrease in global hair density.
Acute telogen effluvium (ATE) has an abrupt onset and generalized scalp hair loss occurring 2-3 months after a triggering event, which could be unidentifiable in up to 33% cases.
The degree of effluvium depends on the severity, duration of exposure and the type of agent, that can be: emotional stress, hormonal changes in the postpartum period, high fever, surgery, surgical/accidental trauma, severe haemorrhage, chronic systemic illness, or immense psychological stress, changes in medication or crash-diets. A summer effect possibly ultraviolet (UV) light induced, manifesting itself in autumn can cause ATE. The incidence of TE is not known, although it is likely that most women will experience at least 1 episode of TE during a lifetime.
ATE can be diagnosed based on relevant medical and personal history and examination subjective complaints, clinical and physical exams or relevant investigations (hair pull test, phototrichogram, blood test…). ATE generates a lot of anxiety in the patient: significant impact on quality of life, self-esteem impairment, and stress increase. Thus, stress may act as a primary inducer; an aggravating factor or be a response to hair loss.
ATE usually remits within few months (3-4 to 6 months) in 95% of cases if the trigger is removed or treated. Complete recovery may take until 1 year. A resolving TE is characterized by the absence of hair shedding, a negative hair pull test and synchronized hair growth.
In this study, our aim is to assess the effects of the RV3466F lotion on hair growth, compared to a control group, with clinical and biometrological non- invasive methods on an adult female population with telogen effluvium.
详细描述
In order to evaluate the interest of the RV3466F lotion in the remission of ET, which occurs naturally when the triggering cause is stopped, ,a comparative controlled group is necessary.
Moreover, due to the type of product (lotion) and the area of application ( scalp), the parallel groups design is adapted to the study purpose.
To increase the adherence to the study protocol and to limit the negative psychological impact of hair shedding without treatment, the control group receive a neutral shampoo (extra mild shampoo).
In order to avoid a bias between groups regarding the associated products, the same shampoo is given for the two groups. It should be used at the usual frequency. The allocation of the study product is randomized.
Only women are included in the study as specified in the claim of the study product.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Criteria related to hair loss disorder:
- •Subject having a proportion of hair in telogen phase superior to 15% (determined by phototrichogram at inclusion) on the centroparietal area of the scalp
- •Subject having a total hair density superior or equal to ≥ 220 hairs/ cm2 (determined by phototrichogram at inclusion) on the centroparietal area of the scalp
- •Non inclusion criteria :
- •Criteria related to treatments and products:
- •Any hair care product applied on the scalp between the selection visit and the inclusion visit (e.g. gel, hairspray, wax, foam, …) or water or brushing.
- •Reaction to the used hair dye during the inclusion visit
排除标准
- 未提供
结局指标
主要结局
anagen to telogen ratio
时间窗: Change from baseline to 16 weeks after application, for each group
From phototrichogram on the centroparietal area of the scalp
次要结局
- anagen to telogen ratio(1 week, 4 weeks and 8 weeks after application, for each group)
- Hair thickness(1 week, 4 weeks, 8 weeks and 16 weeks after application, for each group)
- Cumulative hair thickness(1 week, 4 weeks, 8weeks and 16 weeks after application, for each group)
- Density assessment(1 week and 16 weeks after application, for each group)
- Efficacy and cosmetic acceptability questionnaire(1 week; 4 weeks, 8 weeks and 16 weeks after application, for each group)
- Density of anagen hair (number of hair in anagen phase/cm²)(1 week, 4 weeks, 8 weeks and 16 weeks after application, for each group)
- Percentage of hairs pulled out(1 week, 4 weeks, 8 weeks 12 weeks and 16 weeks after application, for each group)
- Total number of hairs shed(4 weeks, 8 weeks 12 weeks and 16 weeks after application, for each group)
- Density of telogen hair (number of hair in telogen phase/cm²)(1 week, 4 weeks, 8 weeks and 16 weeks after application, for each group)
- Total hair density (number of total hairs/cm²)(1 week; 4 weeks, 8 weeks and 16 weeks after application, for each group)