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CTRI Number  CTRI/2022/04/041890 [Registered on: 18/04/2022] Trial Registered Prospectively
Last Modified On: 21/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics]  
Study Design  Single Arm Study 
Public Title of Study   Effect of baby products 
Scientific Title of Study   A clinical study to evaluate the safety and efficacy of the baby care products on a healthy pediatric population of the age group 01-36 months. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SKIN/MAPS/2022-05 Version 1.0 Dated 24 Mar 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sharil Hegde 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Ground floor, Sensitivity room no. 1, 327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  sharilhegde@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Ritambhara 
Designation  Director- Business and Operation 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Room no.2, Ground floor,327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  ritambhara@mscr.in  
 
Details of Contact Person
Public Query  
Name  Sudhanthiran S 
Designation  Study Manager 
Affiliation  MS Clinical Research Pvt Ltd 
Address  First Floor, Room no. 1, Councelling Area, 327/15, 1st main road, cambridge layout, ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  sudhan@mscr.in  
 
Source of Monetary or Material Support  
Marico Limited Marks, plot no:23-C Mahal, Industrial Estate Mahakali Caves Road, Andheri(E), Mumbai 400093 
 
Primary Sponsor  
Name  Marico Limited 
Address  Marks, plot no:23-C Mahal, Industrial Estate Mahakali Caves Road, Andheri(E), Mumbai 400093  
Type of Sponsor  Other [FMCG(Fast moving Consumer Goods)] 
 
Details of Secondary Sponsor  
Name  Address 
None  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sharil Hegde  MS Clinical Research Pvt. Ltd.  Ground floor, Sensitivity room No. 1 ,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA 		 08041125934
08040917253
sharilhegde@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Pediatric population of the age group 01 to 36 months 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  None  NA 
Intervention  RM.M480.67  Gently massage onto damp skin before bathing, after bathing and before night sleep. Duration - 28 days 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  36.00 Month(s)
Gender  Both 
Details  1. Subjects in the age group 1-12 months, 12-24 months and 24-36 months in nearly equal ratio (both genders inclusive)
2. Subjects in general good health as determined from a recent medical history
3. Subject’s mother/authorized legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up.
4. Subject’s mother/authorized legal representative, preferably mother willing to abide by and comply with the study protocol.
5. Subject’s mother/legal representative agreeing not to use any other product of the same nature and change any habit or other regular products during the study period. 
 
ExclusionCriteria 
Details  1. A known history or present condition or any other concern that may require medical attention
2. Subejcts deemed unfit to participate in the study based on the general health and hygiene.
3. Babies whose parents and/or authorized legal guardian are not willing to sign the informed consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the safety and efficacy of test products on a pediatric population by one month home use test in comparison to the baseline.
2. To evaluate the skin health and quality by dermatological assessment and instrumental evaluation in comparison to the baseline. 		 4 weeeks 
 
Secondary Outcome  
Outcome  TimePoints 
None  NA 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "37"
Final Enrollment numbers achieved (India)="37" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/04/2022 
Date of Study Completion (India) 06/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Study will be conducted to assess the safety and efficacy of the test products. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. For the selected subjects, the test products will be dispensed for the usage of 28 days. The assessment will be performed for week 1, 2 and 4. 
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