Childhood Atopic Dermatitis
Conditions
Keywords
atopic eczema, moisturisers, alternatives, affordable
Brief summary
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.
Interventions
OTHERBaby oil
patient in study 1, arm B washed unscented liquid paraffin (baby oil) in place of aqueous cream
OTHERpetroleum jelly
patients in this arm, use petroleum jelly (vaseline), replacing emulsifying ointment as a moisturiser
OTHERGlycerine:petroleum jelly 2:1
patients in this arm use glycerine and petroleum jelly mixed at a ratio of 2:1 in place of cetomacrogol as a moisturiser
Sponsors
Red Cross War Memorial Childrens Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the validated SCORing Atopic Dermatitis(SCORAD) | Baseline, week 4, 8 and week 12 | 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. |
Secondary
| Measure | 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 |
Countries
South Africa
Outcome results
None listed