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Trial record 45 of 837 for:    eczema

Accessible and Affordable Moisturizers for Atopic Eczema

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ClinicalTrials.gov Identifier: NCT02084472
Recruitment Status : Completed
First Posted : March 12, 2014
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):
Dr Carol Hlela, Red Cross War Memorial Childrens Hospital

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.

Condition or disease Intervention/treatment Phase
Childhood Atopic Dermatitis Other: Baby oil Other: petroleum jelly Other: Glycerine:petroleum jelly 2:1 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Accessible and Affordable Moisturizers for Atopic Eczema: the 2am Atopic Eczema Study
Study Start Date : February 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02084472


Locations
South Africa
Red Cross War Memorial Children's Hospital
Cape Town, Western Cape, South Africa, 7700
Sponsors and Collaborators
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

Responsible Party: Dr Carol Hlela, Dermatologist, Red Cross War Memorial Childrens Hospital
ClinicalTrials.gov Identifier: NCT02084472     History of Changes
Other Study ID Numbers: 146/2013
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: March 2014

Keywords provided by Dr Carol Hlela, Red Cross War Memorial Childrens Hospital:
atopic eczema
moisturisers
alternatives
affordable

Additional relevant MeSH terms:
Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Glycerol
Petrolatum
Mineral Oil
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Emollients
Dermatologic Agents