Prevention of Eczema By a Barrier Lipid Equilibrium Strategy (PEBBLES) pilot study - Testing the compliance and saftey of a strategy for improving infant skin function.
Phase 1
Completed
- Conditions
- eczemaSkin - Dermatological conditions
- Registration Number
- ACTRN12609000727246
- Lead Sponsor
- Murdoch Childrens Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Either mother and/or father has a self reported history of:
- asthma and/or
- eczema/atopic dermatitis and/or
- hayfever/allergic rhinitis and/or
- food allergy
Exclusion Criteria
- A parent who has a known hypersensitivity to any of the ingredients of EpiCeram.
- Multiple births (twins, triplets etc.)
- Premature infants (<36 weeks)
- Infants with major birth or early life medical complications that require admission into a special care nursery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, measured by completion of a daily diary card for the 6-week treatment period (documenting any skin or other symptoms), response at six weeks to the question Do you believe that your baby reacted badly to the cream at any time during the study?, and response to the question How has your baby's health been since birth at 4 and 6 weeks following the initiation of treatment.[6 weeks post randomisation]
- Secondary Outcome Measures
Name Time Method compliance with treatment[4 weeks post randomisation telephone interview, and 6 weeks post randomisation skin assessment and survey];Adverse reaction to the treatment, as defined as one or more of the following skin symptoms: rash, red or discolored, swelling, dryness, itch, tender, or flaking (scaling)[4 weeks post randomisation telephone interview, and 6 weeks post randomisation skin assessment and survey]