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Clinical Trials/ACTRN12613000472774
ACTRN12613000472774
Completed
Phase 2

Does twice daily application of a ceramide dominant cream (EpiCeram) for the first six months of life reduce the incidence of eczema by six months of age, when compared to standard skin care, in infants who have a family history of allergic disease

Murdoch Childrens Research Institute0 sites80 target enrollmentApril 26, 2013

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
eczema
Sponsor
Murdoch Childrens Research Institute
Enrollment
80
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

In this pilot study (80 infants), we assessed if the application of a specific cream (EpiCeram™) to the skin of new-born infant’s twice-daily for six months, would help build up skin barrier function and reduce the risk that these children would develop eczema and allergic sensitisation to foods. Our results revealed a trend towards a reduced risk of eczema and food sensitisation in infants from the ‘cream’ group at 12 months of age, particularly if it was used from within the first two weeks of life, and applied regularly. This was the first time that possible beneficial effects of this type of treatment beyond the treatment period have been demonstrated

Registry
who.int
Start Date
April 26, 2013
End Date
June 16, 2015
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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.
  • \- Infants whose parents are not able to comply with all protocol required visits and procedures.

Outcomes

Primary Outcomes

Not specified

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