CTRI/2024/04/066470尚未招募不适用
A Clinical Study to evaluate the skin irritation potential of Kerrato Hair Fibres on healthy human subjects.
Scinuvo Consumer Products LLP1 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 products would be tested as per the guideline IS4011 for dermal safety assessme****nt.
1. Kerrato Hair Fibres
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 8 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)（—）
入选标准
- •Gender: Non-pregnant, non-lactating female aged between 18 to
- •Subjects willing to give written informed consent 3)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 Skin Irritation Score-erythema & oedema
时间窗: Day 0 , Day 1 and Day 8
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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