Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baby oil | Other | patient in study 1, arm B washed unscented liquid paraffin (baby oil) in place of aqueous cream |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nonhlanhla Khumalo, MD, PhD | University of Cape Town | Study Director |
| Carol Hlela, MD, PhD | Red Cross War Memorial Childrens Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Red Cross War Memorial Children's Hospital | Cape Town | Western Cape | 7700 | South Africa |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
Not provided
Not provided
| ID | Term |
|---|---|
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |