A Clinical Study to evaluate the skin irritation potential of Tiffany Multiple Baby Care Products on healthy human subjects.
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. Fisher-price Baby care Head-to-toe Body wash(0 months+)
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Fisher-price Baby care Shampoo and conditioner (0 months+)
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Fisher-price Baby care Diaper rash cream (0 months+)
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Fisher-price Kids Care Sunscreen SPF 50
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Fisher-price Baby care Wet wipes (0 months+)
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Fisher-price Baby care Massage oil(0 months+)
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Fisher-price Baby care Talcum powder (0 months+)
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Fisher-price Baby Care Moisturising Lotion (0 months+)
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)（—）
- 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 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 Sanjay Gupta
CCFT Laboratories