Evaluation of Skin Safety of test products using Patch Test on Adult Healthy Human Participants with Sensitive Skin. 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 cutaneous tolerance of skin reactions.
研究概览
简要总结
atch test - This test is performed to assess the dermal safety of test products involved in the
trial. 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 then scored using Draize scale.
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
- •a) Voluntary men and women (preferably equal number of males and females) between 18 and 65 years having sensitive skin in nasolabial area as determined by lactic acid sting test.
- •b) Fitzpatrick skin type III to IV.
- •c) Having apparently healthy skin on test area.
- •d) Willingness to discontinue the use of cleansing and/or cosmetic products in the application areas during the course of the trial.
- •e) Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
- •f) Willing to give written informed consent to participate in the trial after informing all information concerning the trial procedures and trial objectives.
- •g) Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the trial.
- •h) Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna…), during the course of the trial.
排除标准
- •a) Pregnancy (by UPT) and lactating women.
- •b) Scars, excessive terminal hair, tattoo, cuts, wounds, irritation symptoms, abrasion, or any other skin condition on the studied area.
- •c) Athletes and subjects with history of excessive sweating.
- •d) Subjects on oral corticosteroid.
- •e) Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV, or any other serious medical illness.
- •f) A participant who the Investigator feels will not be compliant with trial requirements g) Dermatological infection/pathology on the level of studied area.
- •h) Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
- •i) Any clinically significant systemic or cutaneous disease, which may interfere with trial procedures.
- •j) Chronic illness which may influence the outcome of the trial.
- •l) 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 of skin reactions.
时间窗: 48 hours.
次要结局
未报告次要终点