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临床试验/CTRI/2024/06/069167
CTRI/2024/06/069167尚未招募Post Marketing Surveillance

A Clinical Study to evaluate the 72hrs moisturization potential of Amvigor Multiple Personal Care Products

Amvigor Organics Pvt. Ltd1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年6月29日最近更新:

试验速览

阶段
Post Marketing Surveillance
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
Change in Moisture

研究概览

简要总结

Test Product-

1.Aquasoft max lotion

2.Aquasoft max cream

3.Mosturizing lotion #Natural Cholesterol

4.Acne-OC Ultra Gel

5.Mosturizing cream for Psoriasis

  1. Mosturiizer for Pasoriasis

7.Mild cleanser

8.Skin lipid repair lotion #Neo Creamide, Shea& Oats

Dose: Gently massage approx. 1 drop of Cream over one block as assigned (forearm) Route of Administration: Topical Duration: 72 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 or participating in another food, cosmetic or therapeutic trial.

结局指标

主要结局

Change in Moisture

时间窗: T0min, T+30 mins, T+ 2 hours, T+ 8 hours, T+24 hours, T +48 hours, T + 72 hours

次要结局

  • Not Applicable(Not Applicable)

研究者

发起方
Amvigor Organics Pvt. Ltd
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Robin Chugh

CCFT Laboratories

研究点 (1)

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