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临床试验/CTRI/2024/04/066512
CTRI/2024/04/066512尚未招募不适用

A Clinical Study to evaluate the skin irritation potential of Green Dream Bharat Pankhudiyan Holi colors on healthy human subjects

Green Dream Bharat1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年5月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
Change in Skin Irritation Score-erythema & oedema

研究概览

简要总结

The below product would be tested as per the guideline IS4011 for dermal safety assessme****nt.

  1. PANKHUDIYAN HOLI COLOUR-PINK

2. PANKHUDIYAN HOLI COLOUR-YELLOW

3. PANKHUDIYAN HOLI COLOUR-GREEN

4. PANKHUDIYAN HOLI COLOUR-BLUE

The product will be tested for skin irritation on 24 human volunteers.

Assessment would be done on day 0, day 1, with followup visit on day 7 for erythema and Oedema scoring.

Study is done as per BIS standard 4011

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Voluntary man or women between 18 and 65 years.
  • Photo type III to V.
  • Having apparently healthy skin on test area
  • For whom the investigator considers that the compliance will be correct.
  • Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
  • Having signed a Consent Form.
  • Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
  • Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna), during the course of the study.
  • Should be able to read and write (in English, Hindi or local language).
  • Having valid proof of identity and age.

排除标准

  • 1.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 Skin Irritation Score-erythema & oedema

时间窗: Day 0, Day 1 and Day 7

次要结局

  • Not Applicable(Not Applicable)

研究者

发起方
Green Dream Bharat
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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