Accessible and Affordable Moisturizers for Atopic Eczema

Childhood Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084472
• Other study ID #: 146/2013
• Status: Completed
• Phase: N/A
• First received: March 3, 2014
• Last updated: March 9, 2014
• Start date: February 2013
• Est. completion date: July 2013

Study information

• Verified date: March 2014
• Source: Red Cross War Memorial Childrens Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Childhood Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Baby oil
patient in study 1, arm B washed unscented liquid paraffin (baby oil) in place of aqueous cream
• petroleum jelly
patients in this arm, use petroleum jelly (vaseline), replacing emulsifying ointment as a moisturiser
• 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

Locations

Country	Name	City	State
South Africa	Red Cross War Memorial Children's Hospital	Cape Town	Western Cape

Sponsors (1)

Lead Sponsor	Collaborator
Red Cross War Memorial Childrens Hospital

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No