Accessible and Affordable Moisturizers for Atopic Eczema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Childhood Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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study 1: aqueous cream and baby oil

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

Group Type ACTIVE_COMPARATOR

Baby oil

Intervention Type OTHER

patient in study 1, arm B washed unscented liquid paraffin (baby oil) in place of aqueous cream

study 2: emulsifying ointment and cetomacrogol

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

Group Type ACTIVE_COMPARATOR

petroleum jelly

Intervention Type OTHER

patients in this arm, use petroleum jelly (vaseline), replacing emulsifying ointment as a moisturiser

Glycerine:petroleum jelly 2:1

Intervention Type OTHER

patients in this arm use glycerine and petroleum jelly mixed at a ratio of 2:1 in place of cetomacrogol as a moisturiser

Interventions

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Baby oil

patient in study 1, arm B washed unscented liquid paraffin (baby oil) in place of aqueous cream

Intervention Type OTHER

petroleum jelly

patients in this arm, use petroleum jelly (vaseline), replacing emulsifying ointment as a moisturiser

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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unscented liquid paraffin

Eligibility Criteria

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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.