CTRI/2024/07/071549已完成Unknown
An in-Vivo Study to Determine the Sun Protection Factor of N.G Vitamin C Sunscreen- AP4F067
NG Electro Product Private Limited1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年8月10日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Individual MED (iMED) score
研究概览
简要总结
Purpose of the study: To assess the sun protection factor
The study is done on 10 human volunteers with Solar Simulator.
The below products would be tested as per the guideline International Standard ISO 24444
Product Name Vitamin C Sunscreen-AP4F067
研究设计
- 研究类型
- Observational
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
- •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 Individual MED (iMED) score
时间窗: Day 1 and Day 2
次要结局
- Change in the redness of skin(Delayed Erythema Response)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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