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
|
|
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
|
|
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. |