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临床试验/CTRI/2012/02/002455
CTRI/2012/02/002455已完成不适用

Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types.

ITC RD Centre1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年2月27日最近更新:

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 of the given investigational product/s on skin of healthy human volunteers by dermatological visual assessment.

研究概览

简要总结

**Objective:**The objective of this study is to evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers.

Product/s will be evaluated by carrying out patch test under occlusion for 24 hours.

.  Subject Population:

 24 healthy human volunteers (Male and Female 1:1)

Skin types (Oily, Dry, Normal and Combination, 1:1:1:1 ratio).

Duration of study:

5 visits (9 days for each volunteers)

7.  Inclusion / Exclusion Criteria:

7.1 Inclusion Criteria:

�         Subjects age group 18 - 55 years

�         Healthy male & female volunteers

�         Subjects with skin type III to V.

�         Subjects willing to give a written informed consent.

�         Subjects willing to maintain the patch test in position for  24 hours

�         Subject has not participated in a similar investigation in the past two weeks.

�         Subjects willing to come for regular follow up.

�         Subjects ready to follow instructions during the study period.

 7.2  Exclusion Criteria:

�         Infection, allergy on the tested area

�         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

�         Subjects participating in any other cosmetic or therapeutic trial.

�         Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

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

  • •Subjects age group
  • 55 years •Healthy male & female volunteers •Subjects with skin type III to V. •Subjects willing to give a written informed consent. •Subjects willing to maintain the patch test in position for 24 hours •Subject has not participated in a similar investigation in the past two weeks. •Subjects willing to come for regular follow up. •Subjects ready to follow instructions during the study period.

排除标准

  • •Infection, allergy on the tested area •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 •Subjects participating in any other cosmetic or therapeutic trial.
  • •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

The objective of this study is to evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by dermatological visual assessment.

时间窗: 0 hrs, 24 hrs, 7 days post patch removal

次要结局

  • Not Applicable(Not Applicable)

研究者

发起方
ITC RD Centre
申办方类型
Other [FMCG Company]

研究点 (1)

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