Evaluation of dermatological safety of Fairness cream, Under eye cream, Anti-cellulite lotion and Age defying cream with a 48 hours closed patch skin sensitization test on healthy human volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The objective of this study is to evaluate the dermatological safety and potential allergenicity
研究概览
简要总结
It is a sensitization clinical study under dermatological control, monocentric, versus control, vehicles and preservatives. A patch test under occlusion is carried out using the aluminium Finn Chambers of 9mm diameter following CODFI (Contact and Occupational Dermatitis Forum of India) guidelines. The allergens used are the negative control (Vaseline), Fairness cream, Under eye cream, Anti-cellulite lotion and Age defying cream & their vehicles and preservatives. All the antigens are placed at the centre of the Finn chambers and the patch thus prepared is applied on the normal upper back of the healthy subjects for 48 hours.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The patch is removed after 48 hours (day 2) and reading taken after 15 - 20 minutes after removal of patch. The reevaluation for any delayed allergic reaction is done after 96 hours (day 4) and also after one week (day 7) of application.
The irritancy and allergic scoring is done at each visit as per ICDRG scoring for contact dermatitis.
Study would be conducted over a period of 7 days, for each volunteer, which includes a total of 4 visits, at Day 0, 2, 4 and 7.
24 healthy human volunteers between 18 to 55 years of age will be included.
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- ••Healthy volunteers both male and female •Subjects ready to sign the informed consent voluntarily and come for regular follow up. •Subjects of age group
- •55 years •Subjects willing to maintain the applied patch in position for 48 hours •Subjects who have not participated in a similar investigation in the past four weeks. •Subjects ready to follow instructions during the study period.
排除标准
- ••Infection, allergy on the tested area during screening.
- ••Skin allergy antecedents or atopic subjects •Hyper sensitivity to any component of the tested products •Athletes and subjects with history of excessive sweating •Cutaneous disease which may influence the study result •Chronic illness which may influence the cutaneous state.
- ••Subjects on oral corticosteroid with dose 10mg/day •Subject in an exclusion period or participating in any other cosmetic or therapeutic trial.
- ••Any underlying history of uncontrolled medical illness including diabetes mellitus, hypertension, liver disease, HIV, or any other serious medical illness.
结局指标
主要结局
The objective of this study is to evaluate the dermatological safety and potential allergenicity
时间窗: The outcome will be measured for each volunteer completing 7 days in the study (3 assessment visits- Day 2, Day 4 & Day 7)
of Fairness cream, Under eye cream, Anti-cellulite lotion and Age defying cream on skin of healthy human volunteers.
时间窗: The outcome will be measured for each volunteer completing 7 days in the study (3 assessment visits- Day 2, Day 4 & Day 7)
次要结局
- Not Applicable(Not Applicable)