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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
120
patient in study 1, arm B washed unscented liquid paraffin (baby oil) in place of aqueous cream
patients in this arm, use petroleum jelly (vaseline), replacing emulsifying ointment as a moisturiser
patients in this arm use glycerine and petroleum jelly mixed at a ratio of 2:1 in place of cetomacrogol as a moisturiser
Red Cross War Memorial Children's Hospital
Cape Town, Western Cape, South Africa
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.
Time frame: Baseline, week 4, 8 and week 12
Change in the patient quality-of-life as measured by the infants dermatitis quality of life (IDQOL) index at each visit.
Time frame: Baseline, week 4, 8,12
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