NCT07576023已完成不适用
A Randomized Comparative Study to Evaluate the Efficacy of the Shampoo RV5263A - WS0060 Applied for 4 Weeks in Adults Subjects With Recurrent Squamous States of Seborrheic Dermatitis in Comparison to Standard Medical Care and a Cosmetic Shampoo
Pierre Fabre Dermo Cosmetique1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年2月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Dandruff severity (Squire score) after 29 days of product application
研究概览
简要总结
The aim of this study is to evaluate, with clinical and biological assessment methods, the effectiveness of the tested cosmetic product applied during 4 weeks of intensive treatment and compared to a Standard Medical Care (medicine shampoo) and to a comparative cosmetic shampoo, on mild to moderate recurrent squamous states of seborrheic dermatitis.
详细描述
This study is conducted as a monocentric, randomized, controlled and blinded-label study, in parallel groups.
A total number of 90 subjects included and randomized in 3 parallel groups:
- Test group RV5263A - WS0060 cosmetic product
- Comparative group: RV5263A - LC3302 cosmetic product
- Standard medical care group
6 visits are planned:
- Visit 1: Inclusion (Day 1)
- Visit 2: Intermediate visit (Day 4)
- Visit 3: Intermediate visit (Day 7)
- Visit 4: Intermediate visit (Day 15 ± 1 day)
- Visit 5: Intermediate visit (Day 22 ± 3 days)
- Visit 6: End-of-study visit (Day 29 ± 3 days)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female aged between 18 and 70 years included
- •Subject affiliated to a social security system or health insurance, or is a beneficiary if applicable
- •Subject having a squamous state of the scalp:
- •clinically visible (Squire score ≥ 20),
- •recurrent (at least twice a year)
- •having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization
- •Subject having a recent prescription of Standard Medical Care (Ketoconazole 2%) not yet initiated
- •Subject accepting that according to the randomization, the Standard Medical Care can be possibly replaced by another shampoo, including neutral shampoo
- •Subject having a maximum usual shampoo frequency of 3/week
- •Non Inclusion criteria
- •Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
- •Subject having any other dermatologic condition than the studied squamous state on hair/ scalp and liable to interfere with the study assessments:
- •alopecia having caused hair loss on the upper part of the scalp (Norwood Hamilton stage> III, Ludwig ≥ I-4, alopecia aerata, alopecia totalis)
- •raised skin lesion, likely to be traumatized, …
- •Subject having dermatological pathology or evolutive skin lesion on the scalp (contact dermatitis, psoriasis, severe excoriations, severe sunburn, cutaneous bacterial superinfection of the scalp clinically obvious ...)
- •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 (including henna), bleaching, perm, smoothing / straightening performed within 3 weeks before inclusion or planned during the study
- •Any topical hair product (conditioner, serum, mask, gel, lacquer, wax, foam…) or water applied on the scalp between the last shampoo and the inclusion visit
排除标准
- 未提供
研究组 & 干预措施
Test group
Experimental
干预措施: RV5263A - WS0060 (Other)
Comparative group
Other
干预措施: RV5263A - LC3302 (Other)
Standard medical care group
Active Comparator
干预措施: Standard Medical Care (SMC) (Drug)
结局指标
主要结局
Dandruff severity (Squire score) after 29 days of product application
时间窗: Visit 1 (Day 1) and Visit 6 (Day 29 or early termination).
Dandruff severity (Squire score): clinical scoring (from 0 to 80) performed by the investigator
次要结局
- Dandruff severity (Squire score) after 4, 7, 15 and 22 days of product application(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), and Visit 5 (Day 22))
- Intensity of squamous global state(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Irritation state score (pruritus)(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Irritation state score (erythema)(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Irritation state score (burning sensation)(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Immediate irritation state score (pruritus)(Immediately after the 1st application of product)
- Immediate irritation state score (burning sensation)(Immediately after the 1st application of product)
- Investigator Global Assessment(Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Subject Global Assessment(Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Evolution of squamous state (dandruff)(Visit 1 (Day 1), immediately after the 1st application, Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Evolution of discomfort(Visit 1 (Day 1), immediately after the 1st application, Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Quality of Life, specific scalp questionnaire(Visit 1 (Day 1), Visit 4 (Day 15) and Visit 6 (Day 29 or early termination))
- Quality of life, Chronic Itch Burden scale(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Acceptability Questionnaire assessment(Immediately after the 1st application, Visit 4 (Day 15) and Visit 6 (Day 29 or early termination))
- Recording of adverse events(From Visit 1 (Day 1) to Visit 6 (Day 29 or early termination))
- Illustration of subject's squamous state evolution(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Strains of the scalp microbiota(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15))
- Scalp proteic markers(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15))
- Molecular characterization of the scalp sebum(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Molecular characterization of the scalp - lipids(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
研究者
研究点 (1)
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