DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,131
- 试验地点
- 1
- 主要终点
- Erythema
研究概览
简要总结
The aim of this study is to evaluate the satisfaction / tolerance / cosmeticity of Dercos DS
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with dandruff or seborrheic dermatitis
- •All hair types
- •All ethnicities (Asian, Caucasian, Afro-American, African, Hispanic)
- •Including patients with specific occlusion habits (for instance veil use at least 8 hours per day, hat use)
- •Patients willing to provide written informed consent
排除标准
- •Under 12 years old
- •Pregnancy, breast feeding, childbearing potential without adequate contraception, or irregular menstrual cycles.
- •History of allergy, anaphylaxis or hypersensitivity to any of the ingredients of Shampoo any of the ingredients of DERCOS ANTI-DANDRUFF normal to oily hair shampoo
- •History of allergic contact dermatitis secondary to shampoo, conditioner, mask, and/or leave-in.
- •Has any clinical manifestations in the treatment(s) or other disorders that, in the opinion of the investigator, may affect the evaluations or results of the study products.- Inability to stay the study period (56 days +-5 days) without performing any hair/scalp procedure, including coloring, straightening and cutting.
- •Inability to attend all study visits and follow treatment regimen
结局指标
主要结局
Erythema
时间窗: Day 56
Scale (0=absence to 4= very severe)
Itching
时间窗: Day 56
Scale (0=absence to 10= very severe)
Patient product acceptability
时间窗: Day 56
scale ranging from 0=not satisfied at all to 10=very satisfied
Irritation
时间窗: Day 56
Scale (0=absence to 4= very severe)
Improvement
时间窗: Day 56
scale from 0= worse to 5=very clearly improved
Impact of dandruff on patient
时间窗: Day 56
Scale from 0=not bothered at all to 5=very bothered
Assessment of hair fiber and quality
时间窗: Day 56
scale from 0=worsened to 4=very improved
Product respect/protects hair fiber
时间窗: Day 56
scale from 0=no, it is now more damaged/dry than before the treatment to 3=Yes, my hair fiber looks/feels better than before the treatment
Desquamation
时间窗: Day 56
Scale (0=absence to 4= very severe)
Area involved
时间窗: Day 56
scale from \<10% to \>90%
Tolerance
时间窗: Day 28
scale from 0= none to 5=very tolerated
Patient global satisfaction
时间窗: Day 56
scale ranging from 0=not satisfied at all to 10=very satisfied
Patient product efficacy satisfaction
时间窗: Day 56
questionnare with scale ranging from 0=completely disagree to 5=completely agree
Global evaluation by investigator
时间窗: Day 56
Scale from 0=not at all satisfactory at all to 4=very satisfactory
次要结局
未报告次要终点