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临床试验/CTRI/2024/09/073196
CTRI/2024/09/073196已完成Post Marketing Surveillance

A Clinical Study to Evaluate the 48-hours Moisturization Potential of Dermavive Multiple skin Care Formulations on Healthy Human Subjects

UAS Pharmaceuticals Pty Ltd.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年9月10日最近更新:
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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
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Test Product-

1. Dermavive Moisturising Lotion

  1. Dermavive Body Hydrator

  2. Dermavive dry Skin Creme

  3. Dermavive Hydra Cleanser

Dose: Gently massage approx. 1 drop of Cream over one block as assigned (forearm) Route of Administration: Topical Duration: 48 hours

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 or participating in another food, cosmetic or therapeutic trial.

结局指标

主要结局

Change in hydration

时间窗: At T+0min, T+30min, T+2hrs, T+8hrs, T+24hrs, T+48hrs

次要结局

  • Not Applicable(Not Applicable)

研究者

发起方
UAS Pharmaceuticals Pty Ltd.
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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