Trial from ANZCTR


Trial ID ACTRN12609000727246
Trial Status: Registered
Date Submitted: 19/08/2009
Date Registered: 24/08/2009
Prospectively registered

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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.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format In infants with a family history of allergic disease, is daily application of a ceramide dominant emollient for six weeks safe?
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Secondary ID [1] 960 0
Nil
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UTN
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Trial acronym PEBBLES pilot study
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Health condition(s) or problem(s) studied:
eczema 243515 0
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Condition category: Condition code:
Skin Dermatological conditions
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239811 239811 0 0

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Descriptions 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.
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Intervention Code:
Treatment: drugs 241126 0
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Intervention Code:
Prevention 241127 0
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Comparator / control treatment No comparator group
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Control group Uncontrolled
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Primary Outcome: 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. 240573 0
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Timepoint: 6 weeks post randomisation 240573 0
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Secondary Outcome: compliance with treatment 257194 0
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Timepoint: 4 weeks post randomisation telephone interview, and 6 weeks post randomisation skin assessment and survey 257194 0
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Secondary Outcome: 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) 257195 0
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Timepoint: 4 weeks post randomisation telephone interview, and 6 weeks post randomisation skin assessment and survey 257195 0
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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
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Minimum age 1 Weeks
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Maximum age 3 Weeks
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Gender Both males and females
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Healthy volunteers? Yes
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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.
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Nonrandomized trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) All children were allocated to the active treatment arm
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Not applicable
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Single group
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Other design features
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Type of endpoint(s) Safety/efficacy
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Statistical Methods/Analysis
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Phase Phase 1
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Anticipated date of first participant enrolment 24/08/2009
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Date of first participant enrolment 9/03/2010
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled 16/06/2010
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Target sample size 10
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Recruitment status Closed: follow-up complete
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Charities/Societies/Foundations 237501 0
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Name: Australasian College of Dermatology 237501 0
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Address: Suite 2A, Level 2, 9 Blaxland Road, RHODES NSW 2138
PO Box 2065 BORONIA PARK NSW 2111
237501 0
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Country: Australia 237501 0
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Funding Source: Commercial sector/Industry 237502 0
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Name: Ceragenix 237502 0
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Address: Ceragenix Pharmaceuticals, Inc.
1444 Wazee Street, Suite 210
Denver CO 80202
237502 0
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Country: United States of America 237502 0
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Primary Sponsor Charities/Societies/Foundations
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Name: Murdoch Childrens Research Institute
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Address: Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Road Parkville Victoria 3052 Australia
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Country: Australia
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Secondary Sponsor: None 236983 0
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Name: 236983 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Royal Childrens Hospital Human Research Ethics Committee 239621 0
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Address: Royal Childrens Hospital
Flemington Rd
Parkville 3052
VIC
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Country: Australia 239621 0
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Approval Date: 16/07/2009 239621 0
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Submitted Date: 239621 0
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HREC: 29043 239621 0
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Ethics Committee name: Royal Womens Hospital Human Research Ethics Committee 243622 0
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Address: Flemington Rd
Parkville 3052
VIC
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Country: Australia 243622 0
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Approval Date: 31/07/2009 243622 0
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Submitted Date: 243622 0
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HREC: 09/30 243622 0
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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.
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Trial website
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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.
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Public Notes
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Principal Investigator
Title: Dr
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Name: Adrian Lowe
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Address: Level 3, 207 Bouverie St Carlton, 3010 University of Melbourne Victoria
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Country: Australia
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Tel: +61 3 8344 0878
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Fax:
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Email: lowea@unimelb.edu.au
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Contact person for public queries
Title: Dr
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Name: Dr. Adrian Lowe
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Address: Centre for Molecular, Environmental, Genetic, Analytic (MEGA) Epidemiology School of Population Health The University of Melbourne Level 1, 723 Swanston Street, Carlton VIC 3053
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Country: Australia
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Tel: +61 3 8344 0878
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Fax: +61 3 9349 5815
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Email: lowea@unimelb.edu.au
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Contact person for scientific queries
Title: Dr
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Name: Dr. Adrian Lowe
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Address: Centre for MEGA Epidemiology School of Population Health The University of Melbourne Level 1, 723 Swanston Street, Carlton VIC 3053
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Country: Australia
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Tel: +61 3 8344 0878
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Email: lowea@unimelb.edu.au
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Contact person responsible for updating information
Title:
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Name: Dr. Adrian Lowe
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Address: Centre for MEGA Epidemiology School of Population Health The University of Melbourne Level 1, 723 Swanston Street, Carlton VIC 3053
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Country: Australia
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Tel: +61 3 8344 0878
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Fax: +61 3 9349 5815
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Email: lowea@unimelb.edu.au
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Addition Cancer fields
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