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CTRI Number  CTRI/2018/01/011147 [Registered on: 04/01/2018] Trial Registered Prospectively
Last Modified On: 12/02/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective, multicenter, observational study. 
Study Design  Other 
Public Title of Study   Evaluation of facial skin parameters, scalp parameters, hair health and Ayurvedic Prakruti on healthy volunteers in winter and monsoon season. 
Scientific Title of Study   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. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CT-Skin-ITC-01-2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Preeti Chhabra 
Designation  Sr. Consultant Ayurveda 
Affiliation  Krishna Polyclinic 
Address  A-98, Pocket UC, Pocket B, Fateh Nagar, New Delhi, Delhi

New Delhi
DELHI
110018
India 
Phone    
Fax    
Email  drrajchh@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Devesh Kumar 
Designation  Director clinical operations  
Affiliation  IR Innovate Research Pvt. Ltd. 
Address  IR Innovate Research Pvt. Ltd G-13, Newbridge Business Centre, 1st Floor, Inox Tower-B, Plot No. 17, Sector-16A, Film city, Noida,

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9971169602  
Fax    
Email  dr.kumardevesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Devesh Kumar 
Designation  Director clinical operations  
Affiliation  IR Innovate Research Pvt. Ltd. 
Address  IR Innovate Research Pvt. Ltd G-13, Newbridge Business Centre, 1st Floor, Inox Tower-B, Plot No. 17, Sector-16A, Film city, Noida,

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9971169602  
Fax    
Email  dr.kumardevesh@gmail.com  
 
Source of Monetary or Material Support  
ITC Life Sciences and Technology Center 
 
Primary Sponsor  
Name  ITC Life Sciences and Technology Center 
Address  Peenya Industrial Area, No.3, 1st Main, 1st Phase Bangalore- 560058  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr AM Jayaraman  A N Skin and Cosmetic Clinic  New No.4 , Shop No.25, Ground Floor TNHH Shopping Complex Luz Church Road Mylapore, Chennai-600004 lndia
Chennai
TAMIL NADU 		 9444119274

jayaraamana@gmail.com 
Dr Preeti Chhabra  Krishna Polyclinic  A-98, Pocket UC, Pocket B, Fateh Nagar, New Delhi, Delhi 110018
New Delhi
DELHI 		 9891008498

drrajchh@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Good Society for Ethical Research  Approved 
Good Society for Ethical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Facial skin and hair parameters evaluation. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  None  None 
Comparator Agent  None  None 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Female Subjects.
2. Belonging to one of 3 age groups: 1) 20-30 yrs. 2) 35-45 yrs., 3) 50-65 yrs.
3. Subjects willing to give a written informed consent and come for regular follow up.
4. Subjects in generally good health
5. Subjects should not use antibiotic and antiseptic products from during one week prior to study (evaluation days)
6. Subjects without any cuts, marks and open wounds on face, scalp, underarms or toe webs
7. Subjects free of any obvious infection of skin as determined by dermatologist
8. Subject has not participated in a similar investigation in the past four weeks
9. Subjects should not use cosmetic and deodorant products from during study period (on evaluation days).
10. Wheatish complexion (defined by chromameter, L x 50-55)
11. Subjects residing in Delhi/Chennai for the past one year. 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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.
2. Assessment of AyurvedicPrakruti in winter (January and February) in Delhi and monsoon (June and July) inDelhi and Chennai.
 		 Visit 1 and Visit 2 for Seasons-
Winters and Monsoons  
 
Secondary Outcome  
Outcome  TimePoints 
Collection of swabs from eight sites for microbial population studies from-
a. Forehead
b. Cheek
c. Neck (Front and Sides)
d. Nose
e. Around nose (crease)
f. Scalp
g. Axilla / underarm (left & right sides to be combined)
h. Foot – toe webs to be combined
for microbial evaluation in Winter in Delhi and monsoons in Delhi and Chennai.
 		 Visit 1 and Visit 2 for Seasons-
Winters and Monsoons  
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/01/2018 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

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. 

 
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