A Clinical Study to Evaluate the moisturization potential of Deep Revitalise Hydration creme- Normal combination 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
- 1. Change in Skin Hydration
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.
Assessment Time: Day 0 (T0min, T+30 mins), 4 hour, 8 hour, Day1 and Day 14
Assessments:
-
Skin Hydration with Corneometer [Day 0 (baseline and 30min), Day 1 and Day 14]
-
TEWL with Tewameter. [Day 0 (baseline and 30min) and Day 14]
-
Dermascopy with 9 point dermat evaluation for skin texture smoothness Score. [Day 0 (baseline and 30min) and Day 14] (with images)
-
How many hours of Balanced & Weightless Hydration for Smooth Skin was observed?- Day 14
-
T-zone comfort test- consumer questionnaire- yes/No?- 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 Normal to Combination 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
1. Change in Skin Hydration
时间窗: Time Points: Day 0 (T0min, T+30 mins), 4 hour, 8 hour, Day1 and Day 14
2. Change in TEWL with Tewameter
时间窗: Time Points: Day 0 (T0min, T+30 mins), 4 hour, 8 hour, Day1 and Day 14
3. Change in smoothness Score
时间窗: Time Points: Day 0 (T0min, T+30 mins), 4 hour, 8 hour, Day1 and Day 14
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories