Skin irritation and skin sensitization potential (Allergenicity) of 4 test products using HumanRepeat Insult Patch Test (HRIPT) IS 4011:2018 Guidelines.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Evaluation of cutaneous tolerance by dermatological 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 of 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 becomes, over time, increasingly allergic to a
substance through repeated exposure to that substance. It is very different from irritation
because it involves immune response, the reaction becomes worse with repeated exposure, and
it is usually specific to individuals. The HRIPT consists of 2 phases, possibly 3.
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 rest period of 10- 14 days after which the skin is exposed to the
product again in Phase II or the Elicitation Phase. A response in Phase II is usually allergic in
nature. In some cases when reactions at challenge are weak or do not follow a consistent
pattern, it may be necessary to conduct additional studies on a participant to determine if the
responses are indicative of allergy. This is Phase III of the study- Rechallenge Phase. A
Rechallenge may also be performed to verify that the response is persistent.
Result: The study was completed and there were no adverse events that occured during the course of the study.
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
- •Voluntary men and women between 18 and 65 years, with 50 participants having sensitive skin as determined by lactic acid sting test.
- •Fitzpatrick skin type III to V.
- •Having apparently healthy skin on test area.
- •Willingness to discontinue the use of cleansing and/or cosmetic products in the application areas during the course of the trial.
- •Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
- •Willing to give written informed consent to participate in the trial after informing all information concerning the trial procedures and trial objectives.
- •Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the trial.
- •Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna...), during the course of the trial.
- •Should be able to read and write (in English, Hindi, or local language).
- •Ready to wear loose cotton clothes.
- •Having valid proof of identity and age.
- •Subject having not participated in another similar cosmetic or therapeutic trial in the past one month.
排除标准
- •Pregnancy (by UPT) and lactating women.
- •Scars, excessive terminal hair, or tattoo on the studied area.
- •A participant who the Investigator feels will not be compliant with trial requirements.
- •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 trial procedures.
- •Chronic illness which may influence the outcome of the trial.
- •Participants on any medical treatment either systemic or topical which may interfere with the performance of the trial (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.
时间窗: Visit 1: ICD and inclusion/ exclusion. | Induction Phase: Patch application on Visit 1 (V1, V3,V5, V7, V9, V11, V13, V15, V17). | Patch will be removed on Visit 2 (V2, V4, V6, V8, V10, V12,V14, V16, V18). | Patch area will be clinically examined, graded and scored on Visit 3 (V3, V5, V7, V9, V11, V13, V15, V17, V19) | Challenge Phase: Patch application will be on naïve sites on the 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