NCT07292467已完成不适用
Evaluation of the Benefits of Shampoo During 4 Weeks of Treatment and After 24 Weeks With 1 Application Per Week (Maintenance Phase) on Subjects With Moderate to Severe Dandruff and Severe Itching State.
Vichy Laboratoires1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月19日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Dandruff evaluation (non adherent and adherent)
研究概览
简要总结
The goal of this study to evaluate the efficacy of shampoo after 4 weeks (treatment phase) and after 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase) on subjects with moderate to severe dandruff and severe itching state.
Participants will:
Apply investigationnal products 3 time a week during 4 weeks and investigational product once a week and neutral product twice a week during 24 weeks Visit the center 10 times during the study for evaluations Keep a diary of their discomfort and the number of times they use the investigational products
详细描述
=> after 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase)
Primary objective :
• To evaluate the reduction of total dandruff ( adherent and non-adherent)
Secondary objectives:
- To evaluate the Quality of Life (QoL) evolution
- To evaluate the reduction of discomfort (itching, stinging, burning sensation)
- To evaluate the reduction of scales
- To assess the cosmetic properties of investigational product
- To assess the tolerance of investigational product
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At baseline: A moderate to severe level of squames: Total squames score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including an adherent squames score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent squames score at inclusion (The groups must be balanced to ensure an equitable distribution)
- •All types of scalp.
- •Any phototype
- •Questionnaire inclusion: Food habits and sleep (at least 30 vols per item, a subject can be included in both groups)
- •Severe itching score ≥ 7
- •Subject with hair length > 2 cm.
- •Subject having received the information about the study modalities and having given his/her written consent and having signed the "informed consent form" specific for this study, in accordance with the corresponding procedure.
- •Subject usually using a shampoo 3 times a week and accepting to follow a rate of 3 times a week during the whole study period.
- •Subject agreeing not to use any other hair product other than the ones provided for the study (till the end of study); in particular:
- •no styling product (tonic, spray, lotion, foam) three days before the study visit.
- •no treating haircare product (conditioner, hair mask, non-rinsed hair care product, oil….).
- •no anti-scales products (whatever the type: shampoo, treatment...).
- •no hair coloring or hair bleaching within one week prior to any study visit.
- •Subject agreeing not to have a short haircut during the entire study period.
- •Subjects in good general and mental health in the opinion of the investigator
- •Subjects demonstrating understanding of the study procedures, restrictions, and willingness to participate as evidenced by voluntary written informed consent and having received a signed and dated copy of the informed consent form
- •Subjects who have agreed to comply with the procedures and requirements of the study and to attend the scheduled assessment visits
排除标准
- •Subject with scalp psoriasis
- •Subject with more than 60% of white hair influencing the scoring of scales.
- •Subject who has skin marks on the scalp that could interfere with the assessment (pigmentation trouble, scar elements…).
- •Subject with alopecia in vertex (stage > IIIa Hamilton and > I Ludwig)
- •Subject who has used topic treatment for the scalp (anti-hair loss, soothing…) during the last three weeks before the start of the study.
- •Subject who has used products for the scalp (dyeing, bleaching, permanent waving and straightening …) within the three weeks prior to the study.
- •Subject with history of allergy and/or reactions to latex.
- •Subject who has taken:
- •Corticoids (local or per os) within 2 weeks before the study entry
- •Anti-histaminic, anti-fungal, non-steroidal anti-inflammatory, immunosuppressive orlithium-based drugs less than 1 month before the study entry,
- •retinoid acid (local or per os) since less than 6 months before study entry.
- •Subject practicing regularly water sport and/or having regular sauna sessions.
- •Subject exposed to the sun or UV rays in an excessive way during the last month (according to the investigator).
- •Pregnancy, breastfeeding, childbearing potential without adequate contraception, or irregular menstrual cycles.
- •History of drug or alcohol abuse
- •History or suspicion of unreliability, poor cooperation or noncompliance with medical treatment
- •Topical treatment of the scalp with other antifungal medication or with corticosteroids in the last 3 weeks before the start of the study.
- •Systemic use of erythromycin, tetracycline or any of its derivatives, trimethoprim/sulfamethoxazole, or metronidazole within 28 days before the start of the study
- •Subject with personal history of allergy and/or adverse reactions to cosmetic products containing surfactant agents (soaps, shower gel, conditioner …)
- •Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
- •Clinical signs and/or history of immunosuppression
- •Severe disease (e.g. cancer, cardiac infarct, unstable angina pectoris pectoris)
- •Treatment with any other investigational drug in the 4 weeks prior to study entry
- •Employee of the sponsor or the study site
研究组 & 干预措施
Shampoo
干预措施: Selenium disulfide (Other)
结局指标
主要结局
Dandruff evaluation (non adherent and adherent)
时间窗: Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28
Total score of dandruff = score of adherent and non adherent dandruff, which are 2 scales from 0 to 5 "0 is equivalent to no dandruff and 5 indicates a very large quantity of dandruff.
次要结局
- Self-evaluation by subject of discomfort sensation (stinging, itching, burning sensation) on structured scale;(Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28)
- Self-evaluation by subject of dandruff state and greasy aspect on structured scale(Structured scale 0 to 9 (0 is equivalent to none, positive result and 9 indicates hugely, negative result))
- Quality of life questionnaire - Scalpdex(Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28)
- Standardized pictures of the scalp(Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28)
- Efficacy and cutaneaous acceptability(Day 0, Week 4, Week 9, Week 12, Week 14, Week 16, Week 20, Week 24 and Week 28)
研究者
研究点 (1)
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