Evaluation of Skin Safety of a Test Product for Primary Skin Irritation Using Skin Irritation Test (Patch Test in Humans) IS 4011:2018 Guidelines.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Evaluation of skin irritation reactions (erythema, oedema, dryness, scaling wrinkling), using Draize scale.
研究概览
简要总结
Patch test - This test is performed to assess the dermal safety of test products 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
to 4-point scale and oedema is scored on another 0 to 4-point scale (Draize scale)
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 (preferably equal number of males and females) between 18 and 65 years with 50 % having sensitive skin as determined by lactic acid sting test@.
- •Fitzpatrick skin 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.
- •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).
- •Having valid proof of identity and age.
排除标准
- •Pregnancy (by history) and lactating women.
- •Athletes and participants with history of sweating.
- •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 skin irritation reactions (erythema, oedema, dryness, scaling wrinkling), using Draize scale.
时间窗: 48 hours
次要结局
未报告次要终点