A prospective, multicenter, observational study for evaluation of facial skin parameters, scalp parameters, hair health and Ayurvedic Prakruti on healthy volunteers in winter and monsoon season.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- 1.Assessment of skin parameters, scalp parameters and hair health in winter (January and February) in Delhi and Monsoon (June and July) in Delhi and Chennai.
研究概览
简要总结
The purpose of this study is to investigate the characteristics of facial skin and hair parameters of females using various machines for tests, questionnaire and Ayurvedic Prakruti , in the months of June and July in cities Delhi and Chennai and in the months of January and February in Delhi city.
The seasons of the year are marked by changes in a variety of parameters such as temperature, humidity, and intensity of sunlight. Human skin, being in direct contact with the environment, is thus affected directly by these external changes and may exhibit various biophysical changes in response to these factors.
The study is aimed to characterize the impact of a change in seasons between winter and monsoons on these various functional properties of facial skin. The results of such a study will help to comprehensively evaluate the effect of differences in environmental conditions during the winter and monsoon seasons on facial skin.
The study has 2 visits. For Delhi subjects recruited in month of January and February will followup for their visits in Months - June and July whereas for Chennai subjects will come for 2 days visits in Monsoons.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female Subjects.
- •Belonging to one of 3 age groups: 1) 20-30 yrs.
- •35-45 yrs., 3) 50-65 yrs.
- •Subjects willing to give a written informed consent and come for regular follow up.
- •Subjects in generally good health
- •Subjects should not use antibiotic and antiseptic products from during one week prior to study (evaluation days)
- •Subjects without any cuts, marks and open wounds on face, scalp, underarms or toe webs
- •Subjects free of any obvious infection of skin as determined by dermatologist
- •Subject has not participated in a similar investigation in the past four weeks
- •Subjects should not use cosmetic and deodorant products from during study period (on evaluation days).
- •Wheatish complexion (defined by chromameter, L x 50-55)
- •Subjects residing in Delhi/Chennai for the past one year.
排除标准
- •1.Currently or has been undergoing dermatologist skin treatments or procedures within the last 1 month 2.Currently or has been involved in another skin care clinical investigation/ clinical trial within the last 3 months 3.Subjects who have pre-existing or dormant dermatologic conditions (e.g. psoriasis, rosacea, rashes, eczema, many and/or severe excoriations etc.) that could interfere with the outcome of the study as determined by the investigator 4.Subjects with scars which could interfere with investigator’s evaluation.
- •5.Subjects who are pregnant and lactating mothers.
结局指标
主要结局
1.Assessment of skin parameters, scalp parameters and hair health in winter (January and February) in Delhi and Monsoon (June and July) in Delhi and Chennai.
时间窗: Visit 1 and Visit 2 for Seasons- | Winters and Monsoons
2.Assessment of AyurvedicPrakruti in winter (January and February) in Delhi and monsoon (June and July) inDelhi and Chennai.
时间窗: Visit 1 and Visit 2 for Seasons- | Winters and Monsoons
次要结局
- Collection of swabs from eight sites for microbial population studies from-(a.Forehead)