NCT02084472

Accessible and Affordable Moisturizers for Atopic Eczema

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Red Cross War Memorial Childrens Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Childhood Atopic Dermatitis

Interventions

Type	Name	Description
OTHER	Baby oil	patient in study 1, arm B washed unscented liquid paraffin (baby oil) in place of aqueous cream
OTHER	petroleum jelly	patients in this arm, use petroleum jelly (vaseline), replacing emulsifying ointment as a moisturiser
OTHER	Glycerine: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

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-05-01
• Completion: 2013-07-01
• First posted: 2014-03-12
• Last updated: 2014-03-12

Locations

1 site across 1 country: South Africa