CTRI/2020/02/023537Other不适用
A DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THEEFFICACY AND TOLERABILITY OF ANTI-POLLUTION PRODUCT (S) ON FACIAL SKIN OF HEALTHY HUMAN SUBJECTS OVER A PERIOD OF TWO WEEKS
ITC Limited ITC Life Sciences Technology Centre1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2020年2月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- Other
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- To assess the efficacy of two topical test products in comparison with placebo on pollution-induced skin damages used over a period of 2 weeks, based on clinical, instrumental and subjective evaluations done at predetermined time points
研究概览
简要总结
Objective:- To assess the efficacy of two topical test products in comparison with placebo on pollution-induced skin damages used over a period of 2 weeks, based on clinical, instrumental and subjective evaluations done at predetermined time points
Sample Size:- Sufficient number of healthy male and female subjects of age 18-50 years (both inclusive) will be screened to include 264 subjects (preferably in equal ratio of male and female and equal ratio of sensitive and normal skin type) divided in three equal group so that 240 subjects (80 subjects in each group) are expected to complete the study
The study could not be completed due to COVID 19 pandemic
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and female subjects aged 18-50 years old (both inclusive)
- •Occupationally be exposed to an excessively high concentration of air pollution (i.e. outdoor workers)
- •Having sensitive skin or normal skin (as evaluated by stinging test)
- •Have lived in this high air pollution area for at least the past 2 years OR they must have been occupationally exposed to this high air pollution for the past 2 years
- •Not be using fairness or antiaging or sunscreen creams/lotions
- •Free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face
- •Agree not to use any other product/treatment (eg: night cream) on their face during the study period (for male subjects shaving cream/foam/gel can be used for shaving purpose)
- •Agree not to carry out bleaching or any other procedures including facial etc.
- •on face during the study period
- •Agree to remove all jewellery on/around face (e.g., necklace, earrings, nose ring) during VISIA imaging
- •Female subjects with child-bearing potential willing to undergo Urine Pregnancy Test on baseline visit and to use acceptable methods of contraception
- •Subject willing to provide written informed consent and is able to read, speak, write, and understand English or Hindi
- •Ready to follow instructions and study restrictions during the study period.
排除标准
- •Known hypersensitivity to any of the study products or constituents
- •Any significant skin pathology in the test area
- •Currently taking any medication including food supplements, which the Investigator believes may influence the interpretation of the data
- •Having chronic illness or had major surgery in the last year
- •Undergoing any treatment of any skin condition on their face/body
- •Allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else
- •Females in pregnancy (self-declared on screening visit and confirmed by UPT on baseline visit) or lactation at the beginning of the study or planned during the study
- •Participation in any other clinical trial up to 1 month prior to inclusion and during the study
- •Any topical or systemic treatment(s) such as NSAIDs, corticosteroids, retinoids, vitamins etc.
- •that, in the investigator’s judgement, could interfere with the study treatments / assessments, taken 2 weeks prior to inclusion and / or planned during the study
- •Who have started, stopped or changed their hormonal treatment(s) (including contraceptive pill) in the previous one month prior to the study
- •Any history of allergy to NSAIDs, vitiligo, herpes, local infection & epilepsy.
结局指标
主要结局
To assess the efficacy of two topical test products in comparison with placebo on pollution-induced skin damages used over a period of 2 weeks, based on clinical, instrumental and subjective evaluations done at predetermined time points
时间窗: All the examination will be done Day 0, Day 7 and Day 14
次要结局
- Not applicable(Not applicable)
研究者
研究点 (1)
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