A Single Arm Clinical study to Evaluate the efficacy of Reginald men Kratos Moisturizer for skin Moisturisation.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. Change in skin hydration
研究概览
简要总结
A single blind one arm study.
Upon enrollment, each participant was assigned a regimen involving the investigational product and instructed to adhere to general safety and usage precautions as applicable.
Participants were provided with a standardized moisturizer for use prior to product application. After cleansing and patting the face dry, sufficient amount of the investigational product were dispensed and applied as small dots across the face. The product was then gently spread using the fingertips in an outward direction, ensuring that it was not rubbed into the skin.
The investigational product was applied twice daily — once in the morning and once at night — with a minimum interval of six hours between applications. This regimen was maintained for a total duration of 28 days. Male and female (80:20)
Assessment days: day 0, Day 14 and Day 28
Assessments:
1. Change in skin hydration
2. Change in TEWL
3. Change in Smoothness and even skin tone
- Change in skin gloss
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
入选标准
- •Gender Male and female (80:20)
- •Subject having dull or dehydrated skin.
- •Age between18 to
- •Subject willing to give written informed consent
- •Women of child bearing potential must have a negative urine pregnancy test
- •Free of any systemic and dermatologic disorder, which in the opinion of the investigator, will interface with the study results or increase the risk of AE.
- •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
- •Volunteers with skin conditions such as eczema, psoriasis, etc
- •Volunteers with oily skin .
- •Subjects who are pregnant , breast feeding or planning to become pregnant during the study .
- •Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
- •Have open sore or open lesions in the treatment area
- •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 including sensitivities to any of the constituents.
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medications (i.e., biologics), including corticosteroids.
- •Have a history of alcohol or illegal drug/ substance abuse or suspected alcohol or illegal drug/substance abuse in the past 2 years.
结局指标
主要结局
1. Change in skin hydration
时间窗: At day 0, T30min, Day 14 and Day 28
2. Change in TEWL
时间窗: At day 0, T30min, Day 14 and Day 28
3. Change in Smoothness and even skin tone
时间窗: At day 0, T30min, Day 14 and Day 28
4. Change in Skin Gloss
时间窗: At day 0, T30min, Day 14 and Day 28
5. HD Imaging- DSLR
时间窗: At day 0, T30min, Day 14 and Day 28
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories