A Clinical Study to Evaluate the moisturization potential of Deep Revitalise Soothing Creme (Dry & Inflammed Skin)- Eczema Prone skin
概览
- 阶段
- Post Marketing Surveillance
- 状态
- 尚未招募
- 发起方
- Honasa Consumer Limited
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 2. change in TEWL
概览
简要总结
A single blind one arm study.
Each participant entering the trial will be assigned to a regimen of investigational product at marked Test product box and no product at the other box.
Assessments:
-
Skin Hydration with Corneometer [Day 0 (T0min, T+30 mins), Day 1 and Day 14]
-
TEWL with Tewameter [Day 0 (T0min, T+30 mins), Day 1 and Day 14]
-
Dermat evaluation on 9 point ordinal scale for soothing and calm skin (0-9 grading)
-
Before and After images- dermascopy
Subjects will be on study for up to 15 days. Screening & Assigning: Day 0 Follow-ups: on Day1 and day 14
研究设计
- 研究类型
- Pms
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)（—）
入选标准
- •Gender: Male or Female with age 20-
- •Subjects having Dry and Inflammed Skin only.
- •Subjects willing to give written informed consent 4) Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
- •Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- •Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
排除标准
- •Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
- •Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
- •Have open sores or open lesions in the treatment area(s).
- •Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
- •Have participated in any interventional clinical trial in the previous 90 days.
- •Have a known sensitivity to any of the constituents of the test product.
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e.,biologics), including corticosteroids.
- •Have not skin related issues.
结局指标
主要结局
2. change in TEWL
时间窗: At T0min, T30min, T1day, T14days
3. Dermascope
时间窗: At T0min, T30min, T1day, T14days
4. dermat evaluation
时间窗: At T0min, T30min, T1day, T14days
1. Change in skin hydration
时间窗: At T0min, T30min, T1day, T14days
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories