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CTRI Number  CTRI/2019/07/020200 [Registered on: 15/07/2019] Trial Registered Prospectively
Last Modified On: 12/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of paraffin versus ceramide based moisturizers in atopic dermatitis 
Scientific Title of Study   Evaluation of a paraffin based moisturizer as compared to a ceramide based moisturizer in children with atopic dermatitis: A double blinded, two group equivalence randomised controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neetu Bhari 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  RN 4078A, teaching block, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  01126594985  
Fax    
Email  drntbhari@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Neetu Bhari 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  RN 4078A, teaching block, AIIMS, New Delhi


DELHI
110029
India 
Phone  01126594985  
Fax    
Email  drntbhari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sachin Gupta 
Designation  Junior resident 
Affiliation  All India Institute of Medical Sciences 
Address  RN 4070, teaching block, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  7503559773  
Fax    
Email  sachin3062aiims@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  NA 
Address  N/A 
Type of Sponsor  Other [N/A] 
 
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 
Dr Neetu Bhari  All India Institute of Medical Sciences, New Delhi  RN 1142, skin opd, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI 
01126594985

drntbhari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L209||Atopic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ceramide  Ceramide based moisturizer, twice daily application all over body for 6 months 
Intervention  Paraffin  Paraffin based moisturizer, twice daily application all over body for 6 months 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children <18 years of age with mild to moderate AD (SCORAD 15-40) 
 
ExclusionCriteria 
Details  a) Children with severe systemic illness
b) Children receiving systemic immunosuppression therapy in last 1 month
c) Children unable to come for follow up
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Difference in SCORAD in children with mild to moderate AD receiving paraffin based moisturizer compared to ceramide based moisturizer used twice daily at 3 months  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time to remission and disease-free duration in children with mild to moderate AD receiving paraffin based moisturizer compared to ceramide based moisturizer used twice daily at 6 months
 
6 months 

2. Improvement in TEWL values in children with mild to moderate AD receiving paraffin based moisturizer compared to ceramide based moisturizer used twice daily at 6 months as measured by DERMALAB, cortex technologies 
6 months 
3. Quantity of topical corticosteroid required in children with mild to moderate AD receiving paraffin based moisturizer compared to ceramide based moisturizer used twice daily at 6 months  6 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/07/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Atopic dermatitis is chronic relapsing inflammatory disease affecting upto 20% of childrens and 2-8 % adults. Since the main defect in atopic dermatitis is skin barrier dysfunction, use of moisturizers alone or along with topical steroid has shown improvement in disease activity in earlier studies.It is also seen that it results in improvement of duration in remission with reduction in relapse rate as well as decrease in amount of topical corticosteroid requirement. Paraffin based moisturizer are the most commonly used moisturizers, but there are only few studies using this moisturizer and they have shown improvement in disease activity. In recent years, there are many studies using ceramide based moisturizer and showing similar or marginally better improvement in disease activity. There are not many studies comparing different moisturizer though there is a huge difference in cost and patient affordability. There are some studies which has compared different types of moisturizers and found no significant difference. We plan to do this double blinded, two group equivalence randomised controlled trial in 70 children with mild to moderate atopic dermatitis to see their effect on disease activity and skin barrier function. The children will be followed up for 6 months to evaluate all the outcome parameters.

 
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