CTRI/2025/08/093500尚未招募Unknown
A Clinical Study to Evaluate the Safety and Efficacy of Be Bodywise 30% Urea Foot Roll On on Crack Heel Volunteers
Mosaic Wellness Pvt. Ltd1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月3日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Change in Skin Hydration
研究概览
简要总结
Test Product:
- Be Bodywise 30% Urea Foot Roll On
Dose: Gently massage approx. over cracked heels , Route of Administration: Topical Duration: 14days
Time Points: At T0min, T+1hrs, T+7days, T+14days
Assessments:
-
Change in Skin hydration- By Corneometer
-
Change in Cracked heels
3. Change in Skin Smoothness
- Change in Skin Softness
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 or Female with age 18-45
- •Subjects with cracked heel
- •Subjects willing to give written informed consent
- •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/or 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
- •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: At T0min, T+1hrs, T+7days, T+14days
2. Change in Craked Heels
时间窗: At T0min, T+1hrs, T+7days, T+14days
3. Change in Skin Smoothness
时间窗: At T0min, T+1hrs, T+7days, T+14days
4. Change in Skin Softness
时间窗: At T0min, T+1hrs, T+7days, T+14days
次要结局
- 1. SGA(At T14days)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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