Evaluation of the Effects of Shampoo RV3438G in Recurrent Squamous States and Maintenance of the Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Efficacy of the test product RV3438G during the maintenance phase by the global evolution of the squamous state assessed by the investigator
研究概览
简要总结
The aim of the study is to evaluate, with clinical, biological and biometrological assessment methods, the effectiveness of RV3438G shampoo, after 2 weeks of short intensive treatment phase and also the effects of a maintenance phase of 8 weeks in association with a neutral shampoo, or with a gentle balancing shampoo, compared to a neutral shampoo used single.
This is a bicentric, comparative (during the maintenance phase), randomized, controlled and open study, in parallel groups conducted in subjects having mild to moderate recurrent squamous states, for 10 weeks.
4 visits are planned. The maximum duration of the study is 74 days from inclusion visit to the End-of-study visit.
The study area is the whole scalp.
详细描述
4 visits are performed: Visit 1: Inclusion (Day1) : start of the short intensive treatment phase (phase 1) Visit 2: Intermediate visit (Day15 ± 3 days, Week 2) : end of the short treatment intensive phase and start of the maintenance phase (phase 2) Visit 3: Intermediate visit (Day 43 ± 3 days, Week 6) : middle of the maintenance phase Visit 4: End-of-study visit (Day 71 ± 3 days, Week 10) : end of the maintenance phase
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria related to the population:
- •Subject aged between 18 and 60 years included
- •Criteria related to the disease:
- •Subject having a squamous state of the scalp :
- •clinically visible (Squire score ≥ 20),
- •with an intensity of the squamous state superior or equal to 2 on a scale from 0 to 3 on at - least 1 of the 4 scalp areas
- •recurrent (at least twice a year)
- •associated to erythema and pruritus: erythema scoring superior or equal to 1 on a scale from 0 to 3 on at least 1 scalp area desquamating of the 4 scalp areas pruritus scoring assessed by the subject superior or equal to 3 on a numerical scale from 0 to 10 (mean pruritus felt on the last 3 days)
排除标准
- •Criteria related to the diseases / skin condition:
- •Subject having frizzy hair
- •Subject with an alopecia having caused hair loss on the upper part of the scalp (Norwood Hamilton stage> III, Ludwig ≥ I-4, alopecia aerata, alopecia totalis), Seborrheic dermatitis requiring medical treatment
- •Criteria related to treatments and/or products:
- •Systemic treatment with nonsteroidal anti-inflammatory, corticosteroid, antibiotic, antihistamine taken during 5 consecutive days within the 2 weeks before the inclusion or planned during the study and liable to interfere with the study assessments
- •Topical treatment or product applied on the scalp within 2 weeks before the inclusion or planned during the study that can be active on squamous states or that can limit the effectiveness of the study product: anti-inflammatory drugs, ketoconazole, anti-dandruff shampoo, anti-fungal, rinse with vinegar, essential oils ...
- •Any scalp dyeing, bleaching, perm, smoothing / straightening performed within 2 weeks before inclusion
结局指标
主要结局
Efficacy of the test product RV3438G during the maintenance phase by the global evolution of the squamous state assessed by the investigator
时间窗: Assessed after 8 weeks of use, during the maintenance phase
Dandruff score, from 0 to 80, calculated by the investigator with intensity (= severity, score from 1 to 5) x extent (= area, score from 0 to 4), for each quadrant of the scalp
次要结局
- Efficacy of the test product RV3438G during the treatment phase by the global evolution of the squamous state assessed by the investigator(Assessed at baseline and after 2, 6 and 10 weeks of use)
- Efficacy of the test product RV3438G by the erythema evolution of the squamous state assessed by the investigator(assessed at baseline and after 2, 6 and 10 weeks of use)
- Efficacy of the test product RV3438G by the pruritus evolution of the squamous state assessed by the subject(assessed at baseline and after 2, 6 and 10 weeks of use and weekly at home)
- Efficacy of the test product RV3438G by the global evolution of the squamous state assessed by the investigator(assessed after 2, 6 and 10 weeks of use)
- Efficacy of the test product RV3438G by the global evolution of the squamous state assessed by the subject(assessed weekly at home)
- Efficacy of the test product RV3438G by the evolution of the squamous state assessed by the subject(assessed at baseline and after 2, 6 and 10 weeks of use)
- Efficacy of the test product RV3438G by the evolution of the scalp discomfort assessed by the subject(assessed at baseline and weekly at home)
- Efficacy of the test product RV3438G by the analysis of skin microbiota diversity from scalp swab samples(assessed at baseline and after 2 and 10 weeks of use)
- Efficacy of the test product RV3438G by the analysis of skin microbiota composition from scalp swab samples(assessed at baseline and after 2, 6 and 10 weeks of use)
- Efficacy of the test product RV3438G by the analysis of Inflammatory marker evolution from scalp swab samples(assessed at baseline and after 2 and 10 weeks of use)
- Efficacy of the test product RV3438G by the analysis of prurit marker evolution from scalp swab samples(assessed at baseline and after 2 and 10 weeks of use)
- Efficacy of the test product RV3438G by the analysis of cellular cohesion proteins evolution from scalp swab samples(assessed at baseline and after 2 and 10 weeks of use)
- Efficacy of the test product RV3438G by the analysis of molecular profiles of lipids from scalp cigarette paper sample(assessed at baseline and after 2, 6 and 10 weeks of use)
- Compliance of the subjects to the test product RV3438G(through study completion, 10 weeks)
- Efficacy of the test product RV3438G by the Metabolomic analysis from scalp swab samples(assessed at baseline and after 2 and 10 weeks of use)
- Tolerance of the test product RV3438G assessed by the investigator(assessed at baseline and after 2, 6 and 10 weeks of use)