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Accessible and Affordable Moisturizers for Atopic Eczema

NCT02084472 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-03-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Red Cross War Memorial Childrens Hospital

    lead OTHER

Principal Investigators

  • Nonhlanhla Khumalo, MD, PhD · University of Cape Town

  • Carol Hlela, MD, PhD · Red Cross War Memorial Children's Hospital

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-05-31
Completion
2013-07-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02084472 on ClinicalTrials.gov