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OpenTrials
Completed

NCT Number: NCT02084472

Accessible and Affordable Moisturizers for Atopic Eczema

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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Key information

Conditions

Childhood Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Red Cross War Memorial Children's Hospital

Cape Town, Western Cape, 7700, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baby oil

Other

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

Other names: unscented liquid paraffin

Petroleum jelly

Other

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

Glycerine:petroleum jelly 2:1

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Red Cross War Memorial Childrens Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2014
Registry last updated
Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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