Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate the dermatological safety of the investigational products on healthy human subjects
研究概览
简要总结
Objective:
The objective of this study is to evaluate the dermatologicalsafety of the investigational products on healthy human subjects.
Subject Population:
24 healthy human volunteers (Male andFemale 1:1) with Skin types (Oily, Dry, Normal and Combination, 1:1:1:1 ratio).
Duration of study:
Approximately 9 days for each volunteer.
Test Site:
Between the scapula and waist of the subjects, the test siteshould be free of pigmentation, pimple, hair, mole or any dermatologicalcondition that can interfere with the reading.
PatchApplication:
The loaded patch system is applied at the test site of studysubjects starting with the lower edge of the patch system and slowly pressingupwards till the top edge in order to squeeze out the air.
Duration of patch:
The patch will be kept for 24 hours.
References
Study method is based on the Bureau of Indian Standards (BIS)method 13424:2001 for the test product rinse off (soap): 119-185B.
Testmethod described in IS 13424:2001. Safety evaluation of bathing bars and toiletsoaps method of test(First revision, ICS 71.100.40), 2001.
Soap will be dissolvedin distilled water to attain a final 8 % (w/W) dilution as perthe clause 2.2.4 in IS 13424:2001.
Study method is based on the Bureau of IndianStandards (BIS) method 4011:2018- Third Revision - modified in terms of siteof application**.**
Test method described in IS 4011:2018 Methods oftest for safety evaluation of cosmetics, Third revision (ICS 71.100.40).Positive and negative control as per clause 4.3.1.2.4 and Irritation scoringsystem is as per the clause 4.3.1.3, 4.3.2.6 on Draize scale for scoringtreatment sites.
Note- There was anerror noted in the result section of IS 4011:2018, clause 4.3.1.4. in the BISstandard 4011:2018. The combined mean score of positive control is mentioned asless than 2.0 (which is supposed to be above 2.0) The same is been informed tothe BIS Committee for the necessary corrections and has been acknowledged bythem.
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
- •1.Subjects in age group
- •55 years (both the ages inclusive). 2.Healthy male & female subjects. 3.Subjects with Fitzpatrick skin type III to V. 4.Subjects willing to give a voluntary written informed consent. 5.Subjects willing to maintain the patch test in position for 24 hours. 6.Subject having not participated in a similar investigation in the past two weeks. 7.Subjects willing to come for regular follow up visits. 8.Subjects ready to follow instructions during the study period.
排除标准
- •1.Infection, allergy on the tested area.
- •2.Skin allergy, antecedents or atopic subjects.
- •3.Athletes and subjects with history of excessive sweating.
- •4.Cutaneous disease which may influence the study result.
- •5.Subjects on oral corticosteroid.
- •6.Subjects participating in any other cosmetic or therapeutic trial.
- •7.Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
结局指标
主要结局
To evaluate the dermatological safety of the investigational products on healthy human subjects
时间窗: Approximately 9 days for each subject.
次要结局
未报告次要终点