CTRI/2025/10/096595
尚未招募
Post Marketing Surveillance
A Clinical Study to Evaluate the 72 hours Moisturizaton potential of Mosaic Be Bodywise 20% Urea lotion
Mosaic Wellness Pvt. Ltd1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年11月10日最近更新:
概览
- 阶段
- Post Marketing Surveillance
- 状态
- 尚未招募
- 发起方
- Mosaic Wellness Pvt. Ltd
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in hydration and TEWL
概览
简要总结
Test Product:
1. Be Bodywise 20% Urea lotion
Dose: Gently massage approx. 1 drop of over one block as assigned (forearm) Route of Administration: Topical Duration: 72 hours
研究设计
- 研究类型
- Pms
- 分配方式
- Na
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
入选标准
- •1.Gender: Male or Female with age 18-45, with male:female (50:50)ratio with normal , oily (avoid acne and too much oily skin) and combination skin.
- •3 to 4 candidates with Sensitive skin.
- •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
- •Pregnant or nursing mothers 2.Scars, excessive terminal hair or tattoo on the studied area 3.Henna tattoo anywhere on the body (in case of studies involving hair dyes) 4.Dermatological infection or pathology on the level of studied area 5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures 7.Chronic illness which may influence the outcome of the study 8.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month) 9.Subject in an exclusion period.
结局指标
主要结局
Change in hydration and TEWL
时间窗: T0min, T+30 min, T+ 2 hours, T+8 hours, 24 hr, 48hr, 72hrs
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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