Accessible and Affordable Moisturizers for Atopic Eczema

Study Overview
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Brief Summary
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Aqueous (EUA) cream, cetomacrogol (CMG) and emulsifying ointment (HEB) are in South Africa's essential drug list (EDL) but are not available to most rural patients. To assess whether accessible moisturizers can be used as alternatives in atopic eczema (AD), a randomized controlled trial of patients with mild-to-moderate AD, aged 1-12 years was conducted. Two separate sub-studies were conducted using a randomized controlled single (assessor) blind trial design. Study 1 compared UEA vs. liquid paraffin (unscented baby oil) for baths, all patients used HEB as moisturiser. In Study 2, 4 moisturisers were compared -HEB, CMG, petroleum jelly and petroleum jelly/Glycerine (2:1). Assessments (SCORAD, POEM, NESS and IQDOL) carried out at baseline, week 4, 8 and 12. Routine topical steroids and antihistamines were continued as prescribed.

Official Title
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Accessible and Affordable Moisturizers for Atopic Eczema: the 2am Atopic Eczema Study

Conditions
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Childhood Atopic Dermatitis

Intervention / Treatment
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* Other: Baby oil
* Other: petroleum jelly
* Other: Glycerine:petroleum jelly 2:1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Atopic dermatitis as defined by the united kingdom (UK) Working party Diagnostic Criteria Atopic Dermatitis patient with mild to moderate stable atopic eczema with parents/guardians willing and able to apply study moisturizers as directed and commit to attend all visits. Exclusion Criteria: Less than 1 year of age Patients with atopic dermatitis treated with systemic preparations

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study 1: aqueous cream and baby oil<br>enrolled patients in this arm use either aqueous cream or baby oil as a soap substitute | Other: Baby oil<br>* patient in study 1, arm B washed unscented liquid paraffin (baby oil) in place of aqueous cream<br>* Other names: unscented liquid paraffin;|
| Active Comparator: study 2: emulsifying ointment and cetomacrogol<br>patients in this study arm continue to use emulsifying ointment and cetomacrogol as a moisturiser, the current standard of care in our institution | Other: petroleum jelly<br>* patients in this arm, use petroleum jelly (vaseline), replacing emulsifying ointment as a moisturiser<br>Other: Glycerine:petroleum jelly 2:1<br>* patients in this arm use glycerine and petroleum jelly mixed at a ratio of 2:1 in place of cetomacrogol as a moisturiser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the validated SCORing Atopic Dermatitis(SCORAD) | Change in the validated SCORing Atopic Dermatitis(SCORAD) and two other validated clinical scores (Nottingham Atopic Eczema Severity Score(NESS) and Patient Oriented Eczema Measure(POEM) were used to measure the extent/severity of AD. A validated quality-of-life form using the infants dermatitis quality of life (IDQOL) scale was completed by each care-giver at each visit. | Baseline, week 4, 8 and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the patient quality-of-life as measured by the infants dermatitis quality of life (IDQOL) index at each visit. |  | Baseline, week 4, 8,12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic eczema, moisturisers, alternatives, affordable