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CTRI Number  CTRI/2018/02/011691 [Registered on: 05/02/2018] Trial Registered Retrospectively
Last Modified On: 11/02/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Liquid Hand wash ( cosmetics)]  
Study Design  Single Arm Study 
Public Title of Study   To evaluate the moisturizing effect of liquid hand wash 
Scientific Title of Study   To evaluate the moisturizing efficacy and thereby the ability to confer softness of the liquid hand wash in comparison with a benchmark on the skin of healthy human subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SRC/CD/247 Version 1.0 dated: 16/02/2010  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Uma Ayachit 
Designation  Principal Investigator 
Affiliation  Kelkar Education Trusts 
Address  Kelkar Education Trusts, Scientific Research Center,4th Floor, V.G.VAZE College Campus, Mulund (E), Mumbai

Mumbai
MAHARASHTRA
400081
India 
Phone  022-25639644  
Fax    
Email  uma@kelkarcosmetology.com  
 
Details of Contact Person
Scientific Query  
Name  Manmohan Sharma 
Designation  Group Leader 
Affiliation  Dabur India Ltd. 
Address  Dabur India Ltd., Plot No.22, site-IV, Sahibabad, Ghaziabad

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  01203378591  
Fax    
Email  manmohan.sharma@dabur.com  
 
Details of Contact Person
Public Query  
Name  Manmohan Sharma 
Designation  Group Leader 
Affiliation  Dabur India Ltd. 
Address  Dabur India Ltd., Plot No.22, site-IV, Sahibabad, Ghaziabad


UTTAR PRADESH
201010
India 
Phone  01203378591  
Fax    
Email  manmohan.sharma@dabur.com  
 
Source of Monetary or Material Support  
Dabur India Limited, Plot No.22, site-IV, Sahibabad, Ghaziabad-201010, India 
 
Primary Sponsor  
Name  Dabur India Ltd 
Address  Plot No.22, site-IV,Sahibabad, Ghaziabad 
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Uma Ayachit  Kelkar Education Trust, Scientific Research Centre  4th Foor, V.G.VAZE Colege Campus, Mulund (E), Mumbai
Mumbai
MAHARASHTRA 		 022-25639644

uma@kelkarcosmetology.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kelkar Eduction Trust  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  helathy female sunjects  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Benchmark soap bar  Water,Potassium salt of vegetable fatty acid Sodium Laureth Sulphate, Cocomonoethanolamide,Ethylene glycol mono stearate,Salt, perfume.The test product is evaluated at day1,day2,day3, day4 and day5.  
Intervention  Test liquid hand wash  Water,Potassium salt of vegetable fatty acid, Sodium Laureth Sulphate, Cocomonoethanolamide, Ethylene glycol mono stearate,Salt,Methyl Paraben,Propyl Paraben, Perfume.The test product is evaluated at day1,day2,day3, day4 and day5.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Female subjects in generally good health.
2. Subjects in the age group of 18-40 years.
3. Subject has not used any moisturization soap or cream in one month.
4. Subject with dry skin in 30-40 Corneometer range.
5. Subject has not participated in a similar investigation in the past four weeks.
6. Subjects willing to give a written informed consent and come for regular follow up. 
 
ExclusionCriteria 
Details  1. A Known history or present condition of Allergic response to any cosmetic product particularly soap.
2. Subjects with active dermatological conditions that can involve the skin (eg. Psoriasis, eczema, ichthyosis, tinea capitis, etc) other than the condition under study.
3. Chronic medication (e.g. antihistamines, antifungals, corticosteroids, topical steroids, etc.) that might influence the outcome of the study.
4. Subjects who are pregnant or nursing (as confirmed by Urine test for the determination of Pregnancy).
5. Subjects viewed by the investigator as not being able to complete the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the moisturzing effect of liquid hand wash on skin  Day1, Day2, Day3 ,Day4 ,Day5 
 
Secondary Outcome  
Outcome  TimePoints 
Overall safety of the subject throughout the study  Day1, Day2, Day3 ,Day4 ,Day5 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   31/03/2010 
Date of Study Completion (India) 07/04/2010 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="7" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Study was designed to test the moisturziation effect of test product on skin of healthy human subjects. 33 female subjects were enrolled in the study and all 33 subjects completed the study. The study was conducted over a period of 7 days for each subjects. The product need to use left and right forearm as per instruction and evaluation was done by instrument ( corneometer) and subject self assessment on each day. The results shows improvement in skin moisture content against benchmark. All the test products were deemed to be safe and given moisturization to skin. 
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