Accessible and Affordable Moisturizers for Atopic Eczema

March 9, 2014 updated by: Dr Carol Hlela, Red Cross War Memorial Childrens Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7700
        • Red Cross War Memorial Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: study 1: aqueous cream and baby oil
enrolled patients in this arm use either aqueous cream or baby oil as a soap substitute
Other: Baby oil
patient in study 1, arm B washed unscented liquid paraffin (baby oil) in place of aqueous cream
Other Names:
  • unscented liquid paraffin
Active Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the validated SCORing Atopic Dermatitis(SCORAD)
Time Frame: Baseline, week 4, 8 and week 12
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.
Baseline, week 4, 8 and week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, week 4, 8,12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Red Cross War Memorial Childrens Hospital

Investigators

  • Study Director: Nonhlanhla Khumalo, MD, PhD, University of Cape Town
  • Principal Investigator: Carol Hlela, MD, PhD, Red Cross War Memorial Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 9, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Estimate)

March 12, 2014

Last Update Submitted That Met QC Criteria

March 9, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 146/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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