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CTRI Number  CTRI/2020/08/027380 [Registered on: 26/08/2020] Trial Registered Prospectively
Last Modified On: 08/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Safety in Use Study]  
Study Design  Other 
Public Title of Study   Baby Soap study in healthy babies 
Scientific Title of Study   Safety In-Use Study to Assess the Cutaneous Tolerance of Baby Soap in Healthy Babies of 0 to 36 Months of Age 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
C3B00297 Version: 01, Dated 06 Aug 20  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Principal Investigator 
Affiliation  Cliantha Research 
Address  Consumer Research Department Garden View Corporate House No 7 Opp Auda Garden Bodakdev Ahmedabad 380054 India

Ahmadabad
GUJARAT
380054
India 
Phone  9909013286  
Fax  07966219549  
Email  nkpatel@cliantha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Principal Investigator 
Affiliation  Cliantha Research 
Address  Consumer Research Department Garden View Corporate House No 7 Opp Auda Garden Bodakdev Ahmedabad 380054 India

Ahmadabad
GUJARAT
380054
India 
Phone  9909013286  
Fax  07966219549  
Email  nkpatel@cliantha.com  
 
Details of Contact Person
Public Query  
Name  Ms Maheshvari Patel 
Designation  Associate Director-Consumer Research  
Affiliation  Cliantha Research 
Address  Consumer Research Department Garden View Corporate House No 7 Opp Auda Garden Bodakdev Ahmedabad 380054 India

Ahmadabad
GUJARAT
380054
India 
Phone  9909013236  
Fax  07966219549  
Email  mnpatel@cliantha.com  
 
Source of Monetary or Material Support  
OM Children’s Hospital, 304-305, Silver Star Commercial Complex, Silver Star Crossroads, New Chandlodia, Ahmedabad – 382481 
 
Primary Sponsor  
Name  Azafran Innovacion Limited 
Address  Dishman Corporate House, Jayantilal Park BRTS Bus Stop, Iscon-Bopal Road, Ambli, Ahmedabad, Gujarat 380009 
Type of Sponsor  Other [Cosmetics Industries] 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nayan Patel  Cliantha Research  Consumer Research Department, Garden View Corporate House No. 7 Opp. Auda Garden Bodakdev Ahmedabad 380054 India
Ahmadabad
GUJARAT 		 9909013286
07966219549
nkpatel@cliantha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Babies in the age group of 0 (including new born full term babies Day 1) to 36 months (both inclusive at the time of consent). 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Baby soap  Wet baby’s face and body; apply the Baby Soap generously, gently working up a lather and rinse well. Use once daily for 14 days.  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  36.00 Month(s)
Gender  Both 
Details  1) Babies in the age group of 0 (including new born full term babies of Day 1) to 36 months (inclusive of both genders) at the time of consent.
2) APGAR score >7 at 1 and 5 minutes with no resuscitation required at birth for babies of 0-7 days.
3) Babies general in good health as determined from a recent medical history
4) Babies mother/legal representative, preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up.
5) Babies mother/legal representative, preferably mother willing to abide by and comply with the study protocol.
6) Babies should not participate in any other clinical study during participation in the current study. 
 
ExclusionCriteria 
Details  1) Babies’ mother/ legal caretaker not willing to stop the use of other baby body milk /lotion / massage oil or any other baby face/body moisturizing product during the study period.
2) Chronic illness which may influence the cutaneous state as per Investigator.
3) Babies on any systemic medication.
4) Babies participating in a similar clinical study, currently or during the previous 30 days.
5) Any baby, in the Investigators opinion not considered suitable for enrollment.
6) A known history or present condition of allergic response to any other concern that may require medical attention.
7) Babies with medical history (past | present) of significant dermatological diseases or conditions, such as atopy, psoriasis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. porphyria) chronic urticaria, or sunburn, rashes. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. The safety of the test product will be evaluated the on skin in terms of mildness, gentleness and non-irritability of babies’ skin by pediatrician assessment change from baseline.
2. To determine the baby experienced no tear, provide quick clean, smooth and gentle effect on baby skin and hair by subjective assessment questionnaire from babies’ mother/ legal caretaker after test product application on Day 15. 		 1. Day 01 before application to Day 15 after application.
2. Day 15 after test product application. 
 
Secondary Outcome  
Outcome  TimePoints 
1. The effect of test product will be evaluated on improvement in the skin hydration using Corneometer® CM 825 or MoistureMeter SC change from baseline.  1. Day 01 before application to Day 15 after application. 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/08/2020 
Date of Study Completion (India) 30/10/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is proposed to evaluate and establish the benefits of the test product on mildness, gentleness and non-irritability on baby’s skin and soothes the baby’s skin and hair, also determines the experience of no tears and keeps the baby’s skin moisturized and hydrated after bath, upon application relieving dryness, redness, oedema, urticarThis study is proposed to evaluate and establish the benefits of the test product on mildness, gentleness and non-irritability on baby’s skin and soothes the baby’s skin and hair, also determines the experience of no tears and keeps the baby’s skin moisturized and hydrated after bath, upon application relieving dryness, redness, oedema, urticarial and any other reactions. The proposed benefits are evaluated by the paediatrics, subjective assessment questionnaire and instrumental evaluation by the dermatologist/dermatologist trained evaluator and assessment questionnaire at Day 1 and Day15.ial and any other reactions. The proposed benefits are evaluated by the paediatrics, subjective assessment questionnaire and instrumental evaluation by the dermatologist/dermatologist trained evaluator and assessment questionnaire at Day 1 and Day15. 
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