CTRI/2024/12/078606已完成Post Marketing Surveillance
A Clinical Study to Evaluate the 48-hours Moisturization Potential of Piramal Lacto calamine Vitamin C Gel on Healthy Human Subjects
试验速览
- 阶段
- Post Marketing Surveillance
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in hydration, TEWL
研究概览
简要总结
Test Product:
Piramal Lacto Calamine vitamin C 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 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, TEWL
时间窗: T0min, T+24hrs, T+ 48hours
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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