Human Repeat Insult Patch Test (HRIPT) IS 4011:2018 Guidelines.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evaluation of cutaneous tolerance by dermatological scoring (Draize scale for Induction scoring and ICDRG scale for Challenge scoring).
研究概览
简要总结
Topical exposure to chemicals can lead to adverse skin effects or skin intolerances.
While some chemicals will only trigger an irritant response after repeated exposure at the same
skin area, other chemicals will even after a one-time exposure cause irritation.
HRIPT is a standard test; usually performed to check the tolerance of a product on skin after
repeated application of those products on the same site.
Sensitization is the process by which a person, over the time becomes allergic to a substance
through repeated exposure to that substance. It is very different from irritation because it
involves immune response. Reaction becomes worse with repeated exposure, and it is usually
specific to individuals. The HRIPT consists of 3 phases -Induction Phase, Rest Phase, Challenge
Phase.
Phase I is the Induction Phase where product is applied to the skin 9 times over duration of 3
weeks. This is a followed by Phase II which is the rest phase of about 14 days after which the
skin is exposed to the product again in Phase III or the Elicitation/Challenge Phase. A response
in Phase III is usually allergic in nature.
Result: The study was completed with 213 completed cases and no adverse events were reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
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 healthy men and 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.
- •7.Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
- •Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna etc), 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
- •Pregnancy (by UPT) and lactating women.
- •Scars, excessive terminal hair or tattoo on the studied area.
- •Dermatological infection/pathology on the level of studied area.
- •Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
- •Any clinically significant systemic or cutaneous disease, which may interfere with study procedures.
- •Chronic illness which may influence the outcome of the study.
- •Participants on any medical treatment either systemic or topical which may interfere with the performance of the study (presently or in the past 1 month).
- •Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial.
结局指标
主要结局
Evaluation of cutaneous tolerance by dermatological scoring (Draize scale for Induction scoring and ICDRG scale for Challenge scoring).
时间窗: Induction Phase: | - Patch application on Visit V1, V3, V5, V7, V9, V11, V13, V15 and V17. | - Patch removal on Visit 2 (V2, V4, V6, V8, V10, V12, V14, V16 and V18). | - Scoring on Visit 3 (V3, V5, V7, V9, V11, V13, V15, V17, V19) | Rest Phase: 10 – 14 days | Challenge Phase: Patch application will be on naïve sites on the arm/back on V20; patch will be removed at V21 (24 hours). Scoring on V22 (48 hours), V23 (72 hours). V24 (96 hours).
次要结局
未报告次要终点