Accessible and Affordable Moisturizers for Atopic Eczema

Red Cross War Memorial Childrens Hospital

Status: Completed

Conditions: Childhood Atopic Dermatitis

Treatments: Other: Glycerine:petroleum jelly 2:1; Other: petroleum jelly; Other: Baby oil

Study type: Interventional

Funder types: Other

Identifiers

NCT02084472

146/2013

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

study 1: aqueous cream and baby oil

Active Comparator group

Description:

enrolled patients in this arm use either aqueous cream or baby oil as a soap substitute

Treatment:

Other: Baby oil

study 2: emulsifying ointment and cetomacrogol

Active Comparator group

Description:

patients in this study arm continue to use emulsifying ointment and cetomacrogol as a moisturiser, the current standard of care in our institution

Treatment:

Other: Glycerine:petroleum jelly 2:1

Other: petroleum jelly