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Trial registered on ANZCTR


Registration number
ACTRN12609000727246
Ethics application status
Approved
Date submitted
19/08/2009
Date registered
24/08/2009
Date last updated
2/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
In infants with a family history of allergic disease, is daily application of a ceramide dominant emollient for six weeks safe?
Secondary ID [1] 960 0
Nil
Universal Trial Number (UTN)
Trial acronym
PEBBLES pilot study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eczema 243515 0
Condition category
Condition code
Skin 239811 239811 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily use of a ceramide dominant cream (EpiCeram) to infants skin (excluding the infants face and hands). Ingredients in the formulation are Capric Acid, Cholesterol, Citric Acid, Conjugated Linoleic Acid, Dimethicone, Disodium EDTA, E. Cerifera (Candelilla)
Wax, Food Starch Modified Corn Syrup Solids, Glycerin, Glyceryl Stearate, Hydroxypropyl Bispalmitamide MEA
(Ceramide), Palmitic Acid, PEG-100 Stearate, Petrolatum, Phenoxyethanol, Potassium Hydroxide, Purified Water,
Sorbic Acid, Squalane, Xanthan Gum. Approximatly six grams will be applied once per day. Duration of treatment is 6 weeks.
Intervention code [1] 241126 0
Treatment: Drugs
Intervention code [2] 241127 0
Prevention
Comparator / control treatment
No comparator group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240573 0
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.
Timepoint [1] 240573 0
6 weeks post randomisation
Secondary outcome [1] 257194 0
compliance with treatment
Timepoint [1] 257194 0
4 weeks post randomisation telephone interview, and 6 weeks post randomisation skin assessment and survey
Secondary outcome [2] 257195 0
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)
Timepoint [2] 257195 0
4 weeks post randomisation telephone interview, and 6 weeks post randomisation skin assessment and survey

Eligibility
Key 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
Minimum age
1 Weeks
Maximum age
3 Weeks
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All children were allocated to the active treatment arm
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237501 0
Charities/Societies/Foundations
Name [1] 237501 0
Australasian College of Dermatology
Address [1] 237501 0
Suite 2A, Level 2, 9 Blaxland Road, RHODES NSW 2138
PO Box 2065 BORONIA PARK NSW 2111
Country [1] 237501 0
Australia
Funding source category [2] 237502 0
Commercial sector/Industry
Name [2] 237502 0
Ceragenix
Address [2] 237502 0
Ceragenix Pharmaceuticals, Inc.
1444 Wazee Street, Suite 210
Denver CO 80202
Country [2] 237502 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Childrens Research Institute
Address
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Road Parkville Victoria 3052 Australia
Country
Australia
Secondary sponsor category [1] 236983 0
None
Name [1] 236983 0
Address [1] 236983 0
Country [1] 236983 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239621 0
Royal Childrens Hospital Human Research Ethics Committee
Ethics committee address [1] 239621 0
Royal Childrens Hospital
Flemington Rd
Parkville 3052
VIC
Ethics committee country [1] 239621 0
Australia
Date submitted for ethics approval [1] 239621 0
Approval date [1] 239621 0
16/07/2009
Ethics approval number [1] 239621 0
29043
Ethics committee name [2] 243622 0
Royal Womens Hospital Human Research Ethics Committee
Ethics committee address [2] 243622 0
Flemington Rd
Parkville 3052
VIC
Ethics committee country [2] 243622 0
Australia
Date submitted for ethics approval [2] 243622 0
Approval date [2] 243622 0
31/07/2009
Ethics approval number [2] 243622 0
09/30

Summary
Brief summary
Asthma affects approximately 20% of children, is a common cause of hospital admissions, and we do not know how to stop children developing it. Infantile eczema is also common, affecting about a third of children. Infants with eczema often later develop asthma. It is hypothesised sensitisation to allergens can occur via damaged skin associated with eczema, which then increases the risk of asthma.
If this hypothesis is correct, it may be possible to prevent asthma by improving the skin barrier function in infants. There is evidence that a ceramide based emollient (which contains the major components of skin) can improve skin barrier function, while current treatments for eczema do not.
This pilot study is aims to determine if a daily application of a ceramide dominant emollient can improve infant skin barrier function.
Trial website
Trial related presentations / publications
1. Lowe AJ, Tang ML, Dharmage SC, Varigos G, Forster D, Gurrin LC, et al. A phase I study of daily treatment with a ceramide-dominant triple lipid mixture commencing in neonates. BMC Dermatol 2012; 12:3.
Public notes

Contacts
Principal investigator
Name 30047 0
Dr Adrian Lowe
Address 30047 0
Level 3, 207 Bouverie St
Carlton, 3010
University of Melbourne
Victoria
Country 30047 0
Australia
Phone 30047 0
+61 3 8344 0878
Fax 30047 0
Email 30047 0
lowea@unimelb.edu.au
Contact person for public queries
Name 13294 0
Dr Dr. Adrian Lowe
Address 13294 0
Centre for Molecular, Environmental, Genetic, Analytic (MEGA) Epidemiology
School of Population Health
The University of Melbourne
Level 1, 723 Swanston Street,
Carlton VIC 3053
Country 13294 0
Australia
Phone 13294 0
+61 3 8344 0878
Fax 13294 0
+61 3 9349 5815
Email 13294 0
lowea@unimelb.edu.au
Contact person for scientific queries
Name 4222 0
Dr Dr. Adrian Lowe
Address 4222 0
Centre for MEGA Epidemiology
School of Population Health
The University of Melbourne
Level 1, 723 Swanston Street,
Carlton VIC 3053
Country 4222 0
Australia
Phone 4222 0
+61 3 8344 0878
Fax 4222 0
+61 3 9349 5815
Email 4222 0
lowea@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary