Evaluation of the skin safety of 1 soap, for primary skin irritation using a patch test.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Patch Scoring (Erythema and oedema scoring)at 48 hours and 72 hours
研究概览
简要总结
There will be 2 products involved in the study - 1 test product and 3% w/w Sodium Lauryl sulphate solution.
For this study, we need people who show a reaction to Sodium Lauryl Sulphate (Positive Control). Hence an additional patch containing 0.04 ml of 3% w/w SLS solution will be applied on participants to determine people showing a reaction to 3% SLS.
At VISIT 1 (0 hrs): 8% w/w solution of the soap will be prepared. 40 ml of the test products (filter papers dipped in liquid product) and 3% w/w solution of sodium lauryl sulphate will be filled in different wells of Patch chambers which will be applied occlusively on upper arm of participants by Clinical Research Associates at Hour 0. Duration of occlusion will be 24 hours.
At VISIT 2 (24 hrs): Patch will be removed.
At VISIT 3 (48 hrs): Scoring of test area (skin on upper arm) will be performed.
Participants will be called for follow up visit at 72 hours. If reactions are observed they will be called 1 week thereafter and later if necessary at the discretion of the Investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Voluntary men and/or women between 18 and 65 years.
- •â€¢Having apparently healthy skin on test area.
- •â€¢Willingness to discontinue the use of cleansing and/or cosmetic products in the treatment areas during the course of the study.
- •â€¢Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
- •â€¢Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna…), during the course of the study.
- •â€¢Ready to wear loose cotton clothes.
排除标准
- •â€¢Pregnant women and lactating women (by history).
- •â€¢Scars, excessive terminal hair or tattoo on the studied area.
- •â€¢Dermatological infection/pathology on the level of studied area.
- •â€¢Hypersensitivity, allergy antecedent (to any cosmetic product, raw material).
- •â€¢Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
- •â€¢Participants on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
结局指标
主要结局
Patch Scoring (Erythema and oedema scoring)at 48 hours and 72 hours
时间窗: Patch Scoring (Erythema and oedema scoring)at 48 hours and 72 hours
次要结局
- Not Applicable(Not Applicable)