Comparison of paraffin versus ceramide based moisturizers in atopic dermatitis

Not yet recruiting

Conditions: Atopic dermatitis, unspecified,

Registration Number: CTRI/2019/07/020200

Lead Sponsor: NA

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

Children <18 years of age with mild to moderate AD (SCORAD 15-40).

Exclusion Criteria

a)Children with severe systemic illness b)Children receiving systemic immunosuppression therapy in last 1 month c)Children unable to come for follow up.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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
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

Trial Locations

Locations (1): All India Institute of Medical Sciences, New Delhi
🇮🇳
Delhi, DELHI, India
All India Institute of Medical Sciences, New Delhi
🇮🇳Delhi, DELHI, India
Dr Neetu Bhari
Principal investigator
01126594985
drntbhari@gmail.com