NCT07133334已完成不适用
Evaluation and Comparison of the Benefits of Routine vs Shampoo Alone During 4 Weeks of Treatment and 12 Weeks Remanence n Subjects With Moderate to Severe Dandruff
Vichy Laboratoires1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年4月2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
- 80
- 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 is to to evaluate and compare the efficacy of the routine "Shampoo + Conditioner " versus " Shampoo alone" immediately after application and after 1 week, 2 weeks, 3 weeks, 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks and 12 weeks after applications stop (remanence phase) on subjects with moderate to severe dandruff.
Participants will:
Apply investigationnal products 3 time a week during 4 weeks and neutral or investigational products 3 time a week during 12 weeks Visit the center 9 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
Secondary objectives:
- To evaluate and compare the Quality of Life (QoL) evolution of the routine " Shampoo and Conditioner " versus " Shampoo " alone, immediately after application and after 1, 2, 3, 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks and 12 weeks after applications stop (remanence phase);
- To assess and compare the cosmetic properties of routine " Shampoo and Conditioner " versus " Shampoo " alone, immediately after application and after 1, 2, 3 and 4 weeks of use (treatment phase);
- To assess the tolerance of routine " Shampoo and Conditioner " versus " Shampoo " alone, during 4 weeks of use.
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 (groups must be equilibrating);
- •Patient with hair length > 2 cm;
- •Patient 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;
- •Patient usually using a shampoo 2 to 3 times a week and accepting to follow this rate during the whole study period;
- •Patient having stopped any possible soothing, anti-dandruff and anti-hair loss treatment (per os or topical) 2 weeks prior to study beginning D-14;
- •Patient 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 colouring or hair bleaching within one week prior to any study visit.
排除标准
- •Subject with psoriasis;
- •Pregnancy, breast feeding, 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 start of the study;
- •Systemic use of retinoids, erythromycin, tetracycline or any of its derivatives, trimethoprim/sulfamethoxazole, or metronidazole within 28 days before the start of the study.
- •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);
- •Treatment with any other investigational drug in the 4 weeks prior to study entry.
研究组 & 干预措施
Routine Dercos
Shampoo + conditionner
干预措施: Selenium disulfide (Other)
Routine Dercos
Shampoo + conditionner
干预措施: Piroctone olamine (Other)
Shampoo alone Dercos
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, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16
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, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16)
- Self-evaluation by subject of dandruff state and greasy aspect on structured scale(Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16)
- Standardized pictures of the scalp(Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16)
- Efficacy and cutaneaous acceptability(Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16)
- Quality of life questionnaire - Scalpdex(Day 0, Day 3, Week 1, Week 2, Week 3, Week 4, Week 9, Week 12, Week 14, Week 16)
研究者
研究点 (1)
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