An interventional study of Baby oil and petroleum jelly in Childhood Atopic Dermatitis, sponsored by Red Cross War Memorial Childrens Hospital. Completed at 1 site in South Africa. Open to participants aged 6 Months to 12 Years. Per ClinicalTrials.gov, last updated 2014-03-12.
Sponsored by Red Cross War Memorial Childrens Hospital · Not applicable and Interventional
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 120 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Red Cross War Memorial Childrens Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
enrolled patients in this arm use either aqueous cream or baby oil as a soap substitute
Other: Baby oil
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 · Other: Glycerine:petroleum jelly 2:1
patient in study 1, arm B washed unscented liquid paraffin (baby oil) in place of aqueous cream
Also known as: unscented liquid paraffin
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
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
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Red Cross War Memorial Childrens Hospital