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CTRI Number  CTRI/2021/02/031265 [Registered on: 12/02/2021] Trial Registered Prospectively
Last Modified On: 29/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [safety and efficacy]  
Study Design  Other 
Public Title of Study   Effect of test product on mild to moderate diaper rashes 
Scientific Title of Study   An Open-Label, Single-Arm Study to Evaluate Efficacy and Safety of Test Product i.e. Diaper Rash Ointment in Healthy Babies of 0 to 36 Months of Age 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
C3B00043, Version#01, Dated: 22 Jan 21  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 Phone 917966219500 Fax 917966219549

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 Phone 917966219500 Fax 917966219549


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 Phone 917966219500 Fax 917966219549

Ahmadabad
GUJARAT
380054
India 
Phone  9909013236  
Fax  07966219549  
Email  mnpatel@cliantha.com  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  Zydus Wellness Limited  
Address  Zydus Wellness Limited House No. 6 and 7, Sigma Commerce Zone, Near Iskcon Temple, Sarkhej - Gandhinagar Highway, Ahmedabad 380015, Gujarat Tel 91 79 67775888  
Type of Sponsor  Other [FMCG] 
 
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   Department: Consumer Research Garden View Corporate House No 7, Opp. Auda Garden, Bodakdev, Ahmedabad 380054, India Phone 917966219500 Fax 917966219549
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 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diaper Rash Ointment  apply 1.5 g to 2.5 g of test product (as per requirement) directly on the baby’s affected rash site, around buttocks and thighs area also between the buttocks and thigh folds.  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  36.00 Month(s)
Gender  Both 
Details  1. Baby in the age group of 0 including newborn babies Day 1 to 36 months inclusive of both genders at the time of consent.
2. Baby generally in good health as determined from recent medical history.
3. Baby who wears diapers at least 12 hours per day.
4. Babies with the presence of Overall Severity Score greater than or equal to 1.5 as determined by the trained evaluator
5. Baby mother or legal representative, preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up.
6. Baby mother or legal representative, willing to ensure that their child continues to wear their usual brand of diapers and will continue to clean their child during diaper changes using their usual products and method with the exception of ointments, lotions, creams, or powders during the trial.
7. Baby mother or legal representative willing to refrain from changing any other products whose use may have an effect on their childs skin condition during the trial example laundry detergents, fabric softeners, and products used to bath the child.
8. Baby mother or legal representative, preferably mother willing to abide by and comply with the study protocol.
9. Babies should not participate in any other clinical study during participation in the current study. 
 
ExclusionCriteria 
Details  1. Baby mother or legal caretaker not willing to stop the use of other baby body milk or lotion or cream or any other baby face or body moisturizing product during the study period.
2. Chronic illness which may influence the cutaneous state.
3. Babies currently being toilet trained.
4. Baby 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 or present of significant dermatological diseases or conditions, such as atopy, psoriasis, eczema, vitiligo or other conditions known to alter skin appearance or physiologic response example 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. To assess overall severity scoring scale change from baseline Day 01 before application to after test product application.
2. To assess baby diaper rash skin in terms of mildness, gentleness, and non-irritability, erythema or redness, dryness, itching, rashes, oedema, pruritus, urticaria of babies’ skin by using pediatrician assessment by the consulting pediatrician
3. To assess subjective self-assessment questionnaire after test product use. 		 1. at Time 6 hour, 12 hours, 24 hours, Day 07 and Day 14 by Pediatrician.
2. Day 01 before application to after test product application at Time 30 min, 1 hour, 2 hours, 4 hours, 6 hour, 12 hours, 24 hours, Day 07 and Day 14
3. Time 30 min, 1 hour, 2 hours, 4 hours, 8 hour, 12 hours, 24 hours, Day 07 and Day 14
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess effect of test product on baby diaper rash skin for erythema using Mexameter® MX 18
2. To assess effect of test product on baby diaper rash skin for barrier function by transepidermal water loss (TEWL) using TEWAmeter® TM 300 or Vapometer
3. To evaluate the pain relief ability of test product on baby diaper rash skin by VAS scoring scale
4. To evaluate the effect of test product on adult subject’s/baby’s affected skin pH using Skin pH meter 		 1. Day 01 before application to after test product application at Time 6 hour, 12 hours, 24 hours, Day 07 and Day 14.
2. Day 01 before application to after test product application at Time 6 hour, 12 hours, 24 hours, Day 07 and Day 14.
3. Day 01 before application to after test product application at 12 hours, 24 hours, Day 07 and Day 14.
4. Day 01 before application to Day 14 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/02/2021 
Date of Study Completion (India) 29/04/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="14" 
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, also determine the experience of faster relief from pain of and keeps the baby’s skin moisturized, upon application relieving dryness, redness, oedema, urticaria and any other reactions. The proposed benefits are evaluated by the Paediatrics, subjective assessment questionnaire and instrumental evaluation at Day 1, Day 2, Day 3, Day 7 and Day 14.

 
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