Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Evaluation of dermatological safety of investigational products by 24 hours patch test under complete occlusion on healthy human subjects.
研究概览
简要总结
Study was designed to test the safety of topical products provided by Dabur India Limited on healthy human subjects. 24 subjects were enrolled in the study, and all the subjects completed the study. The study was conducted over a period of approximately 9 days for each subject. 40 micro litre of the test product was patched on the back of the subject under occlusion for 24 hrs. The skin was evaluated for signs of irritation identified under Erythema and odema, using Draize’s scale.
After patch removal, skin was observed for irritation reactions at 0 hr, 24 hrs post patch removal for immediate reactions and 7 days post patch removal for delayed reactions. As per Draize scale for scoring irritation, all the investigational products emerged as non irritant products when observed at Ohr, 24 hours and 7 days post patch removal.
All the test products were deemed to be dermatologically safe as per their classification into non irritant category at all time points of evaluation by 24 hrs occlusive patch test method (reference BIS 4011:1997).3% SLS was used as positive control in the study was confirmed as irritant when observed at Ohr & 24hrs and was confirmed as mild irritant when observed at 7 days post patch removaL
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Subjects in age group 18- 55 years 2 Healthy male & female subjects 3 Subjects with Fitzpatrick skin type III to V.
- •4 Subjects willing to give a 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 Hyper sensitivity to any component of the tested products 4 Athletes and subjects with history of excessive sweating 5 Cutaneous disease which may influence the study result 6 Chronic illness which may influence the cutaneous state.
- •7 Subjects on oral corticosteroid 8 Subjects participating in any other cosmetic or therapeutic study.
- •9 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
Evaluation of dermatological safety of investigational products by 24 hours patch test under complete occlusion on healthy human subjects.
时间窗: 0 hr, 24 hr, 7 days
次要结局
- Overall safety of Subjects(0 hr, 24 hr, 7 days)