CTRI/2024/12/078451暂停Post Marketing Surveillance
A Clinical Study to Evaluate the 48-hours Moisturization Potential of Piramal Lacto calamine Retinol Gel on Healthy Human Subjects
试验速览
- 阶段
- Post Marketing Surveillance
- 状态
- 暂停
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in hydration
研究概览
简要总结
Test Product:
Piramal Lacto Calamine Retinol Gel
Dose: Gently massage approx. 1 drop of over one block as assigned (forearm) Route of Administration: Topical Duration: 48 hour
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
- 18.00 Year(s) 至 50.00 Year(s)（—）
入选标准
- •1.Gender: Male or Female with age 18-
- •Subjects willing to give written informed consent 3.Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
- •4.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
- •Subject with oily skin or with too much Sweating
- •Have open sores or open lesions in the treatment area(s)..
- •4.Scars, excessive terminal hair or tattoo on the studied area 5.Henna tattoo anywhere on the body (in case of studies involving hair dyes) 6.Dermatological infection or pathology on the level of studied area 7.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 8.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures 9.Chronic illness which may influence the outcome of the study 10.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) 11.Have a known sensitivity to any of the constituents of the test product 12.Have not skin related issues.
结局指标
主要结局
Change in hydration
时间窗: T0min,T30min, T2hrs, T8hrs, T+24hrs, T+ 48hours
次要结局
- Change in TEWL(T0min, T30min, T24hrs, T48hrs)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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