Accessible and Affordable Moisturizers for Atopic Eczema

NCT02084472 | Completed

• 1 other identifier: 146/2013
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

atopic eczema; moisturisers; alternatives; affordable

Outcome Measures

Primary Outcomes (1)

• Change in the validated SCORing Atopic Dermatitis(SCORAD)

  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 Outcomes (1)

• Change in the patient quality-of-life as measured by the infants dermatitis quality of life (IDQOL) index at each visit.

  Baseline, week 4, 8,12

Study Arms (2)

study 1: aqueous cream and baby oil

ACTIVE COMPARATOR

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

Other: Baby oil

study 2: emulsifying ointment and cetomacrogol

ACTIVE COMPARATOR

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; Other: Glycerine:petroleum jelly 2:1

Interventions

Baby oil OTHER

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

Also known as: unscented liquid paraffin

study 1: aqueous cream and baby oil

petroleum jelly OTHER

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

study 2: emulsifying ointment and cetomacrogol

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

study 2: emulsifying ointment and cetomacrogol

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Less than 1 year of age
• Patients with atopic dermatitis treated with systemic preparations

Sponsors & Collaborators

• Red Cross War Memorial Childrens Hospital: lead

Study Sites (1)

Red Cross War Memorial Children's Hospital

Cape Town, Western Cape, 7700, South Africa

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Petrolatum

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Study Officials

• Nonhlanhla Khumalo, MD, PhD

  University of Cape Town

  STUDY DIRECTOR

• Carol Hlela, MD, PhD

  Red Cross War Memorial Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 12, 2014
• Study Start: February 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 12, 2014

Record last verified: 2014-03

Locations

ZA (1)