Evaluation of dermatological safety and hypo-allergenicity of investigational products by Human Repeat Insult Patch Test (HRIPT) on healthy human volunteers as per IS 4011:2018
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1. To determine the irritation & or sensitization
研究概览
简要总结
Study will be conducted over a period of 40 days for each subject, there is first induction phase where patches will be applied on thrice a week basis for three weeks, a two-week washout period is called rest phase involves no application of any patch in order to develop sensitization to the test product, immediately followed by challenge phase and then observation for 24hrs, 48 hrs and 72 hrs after patch removal.
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
- •1.Voluntary men/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/nursing mothers
- •Scars, excessive terminal hair or tattoo on the studied area.
- •Henna tattoo anywhere on the body (in case of studies involving hair dyes).
- •Dermatological infection/pathology on the level of studied area.
- •Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye).
- •Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
- •Chronic illness which may influence the outcome of the study.
- •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).
- •Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
结局指标
主要结局
1. To determine the irritation & or sensitization
时间窗: Day 1 to Day 40.
potential of a test material.
时间窗: Day 1 to Day 40.
2. In support of sensitive skin claims &
时间窗: Day 1 to Day 40.
supporting evidence for hypo allergenicity claims
时间窗: Day 1 to Day 40.
after repeated application under occlusive or
时间窗: Day 1 to Day 40.
semi occlusive patches to the skin of human
时间窗: Day 1 to Day 40.
subjects.
时间窗: Day 1 to Day 40.
次要结局
- Incidence & rate of adverse events.(Day 1 to Day 40)
研究者
Dr Ashok Godavarthi
Radiant Research Services Pvt Ltd