Skin Irritation Test (Patch Test in Humans) 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
- 26
- 试验地点
- 1
- 主要终点
- Evaluation of skin irritation reactions using
研究概览
简要总结
This test is performed to assess the dermal safety of test product involved in the
study. It is a technique used to determine the potential of specific substances to cause irritancy
of the skin. Irritants are substances that damage the skin by direct toxic action. The damage
will depend upon the nature of the irritant, its concentration, and duration of exposure.
Irritation is manifested as inflammatory responses such as erythema (redness), oedema
(swelling), vesiculation and finally to an intense suppurative reaction without the involvement
of immune system.
In general, patches are applied for a contact period of 24 hours, and skin reaction is assessed
under a constant artificial daylight source and the marked site is scored post 24 hours after the
removal of the patches. Reactions such as erythema, dryness and wrinkling are scored on a 0
– 4-point scale and oedema is scored on another 0 – 4-point scale (Draize scale)
Result: The study was completed with 26 complete cases and no adverse events were reported.
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 men and women (preferably equal number of males and females) 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 water contact (i.e.: swimming) or activity which cause sweating (i.e.: 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
- •Pregnancy (by history) 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 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 skin irritation reactions using
时间窗: 48 hours
Draize scale.
时间窗: 48 hours
次要结局
未报告次要终点
研究者
Dr Rajiv Joshi
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.)