跳至主要内容
临床试验/CTRI/2024/12/078337
CTRI/2024/12/078337已完成Post Marketing Surveillance

A Clinical study to Evaluate the 8hrs Moisturization Potential of Syndent Soap Rose-GC-S118 and GC-S121

Wipro Yardley FZE1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年12月24日最近更新:

试验速览

阶段
Post Marketing Surveillance
状态
已完成
发起方
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:

Syndent Soap Rose-GC-S118 and GC-S121

Dose: wash the assigned area and make the hydration assessment via corneometer at

0min, 30min, 2 hour, 8 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, T2Hours, T8Hours

次要结局

  • Change in TEWL(T0min, T30min, T8Hours)

研究者

发起方
Wipro Yardley FZE
申办方类型
Pharmaceutical industry-Global
责任方
Principal Investigator
主要研究者

Dr Robin Chugh

CCFT Laboratories

研究点 (1)

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