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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03667651
Registration number
NCT03667651
Ethics application status
Date submitted
9/09/2018
Date registered
12/09/2018
Titles & IDs
Public title
The PEBBLES Study - Testing a Strategy for Preventing Eczema and Food Allergy in High Risk Infants
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Scientific title
THE PEBBLES STUDY: A Randomised Controlled Trial to Prevent Eczema, Food Allergy and Sensitisation Using a Skin Barrier Improvement Strategy
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Secondary ID [1]
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ACTRN12617001380381
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Secondary ID [2]
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HREC/17/RCHM/221
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Universal Trial Number (UTN)
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Trial acronym
PEBBLES
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Eczema
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Asthma
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Allergy;Food
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Condition category
Condition code
Skin
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Dermatological conditions
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Inflammatory and Immune System
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - EpiCeram
Active comparator: Twice daily use treatment with EpiCeram - They will be instructed to apply EpiCeram™ to the full skin surface of their child twice per day for 6 months. The prophylactic use of EpiCeram™ is the intervention that is being tested for its effect on infant skin barrier function. We will instruct parents to apply approximately 6 grams of EpiCeram™ per application at two regular times each day, including after bathing the infant, or at the time they would normally bathe their child.
No intervention: Standard skin care - Parents are to follow standard skin care practices
Treatment: Drugs: EpiCeram
Parents will be instructed to apply EpiCeram™ to the full skin surface of their child twice per day for six months.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Presence of eczema
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Assessment method [1]
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as assessed using i) the UK working party criteria for eczema and/or ii) blinded investigator observed eczema.
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Timepoint [1]
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12 months of age.
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Primary outcome [2]
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Confirmed diagnosis of food allergy at 12 months (52 weeks).
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Assessment method [2]
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This diagnosis is derived from a combination of allergic sensitisation, reaction history and food challenge. A skin prick test to six common allergens will be performed (egg white, cows' milk, peanut, dust mite, cat dander, and rye grass) along with a negative (saline) and a positive (histamine) control. Participants that are sensitised to certain foods (\>=1mm wheal) during the skin prick testing will be given a challenge to determine if they are allergic to those foods. This will be conducted at the MCRI Allergy Clinic under the supervision of a Doctor specifically trained in oral food challenges.
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Timepoint [2]
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12 months of age
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Secondary outcome [1]
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Eczema severity
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Assessment method [1]
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assessed using the EASI score
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Timepoint [1]
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12 months of age
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Secondary outcome [2]
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Parent report of a community doctor diagnosis of eczema
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Assessment method [2]
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Timepoint [2]
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12 months of age
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Secondary outcome [3]
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infant skin barrier function
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Assessment method [3]
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As assessed by Trans-epidermal water loss (Vapometer)
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Timepoint [3]
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At 6 weeks and 12 months of age
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Secondary outcome [4]
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Parental compliance with a program to build infant skin barrier function
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Assessment method [4]
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as assessed by parental completion of weekly diary cards and weighing of the tubes of study cream at each visit
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Timepoint [4]
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At 6 weeks and 6 months of age.
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Secondary outcome [5]
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Adverse events
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Assessment method [5]
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as assessed by the documentation of any untoward medical occurrence in a participant enrolled into this study
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Timepoint [5]
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From recruitment of infant until final study visit at 12 months of age.
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Secondary outcome [6]
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skin microbial colonisation, or skin lipid profile
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Assessment method [6]
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Assessed using skin swabs at baseline, 6 weeks and 12 months of age
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Timepoint [6]
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At 6 weeks and 6 and 12 months of age
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Eligibility
Key inclusion criteria
Infants will be eligible for this study if their mother, father, or an older sibling has a self-reported history of at least one of the following conditions:
* asthma,
* eczema/atopic dermatitis,
* hay fever/ allergic rhinitis or
* food allergy
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Minimum age
No limit
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Maximum age
3
Weeks
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
infants with any of the following will be excluded:
* A parent who has a known hypersensitivity to any of the ingredients of EpiCeram™ will be excluded, as it would be difficult for these parents to apply EpiCeram™ to their infant, and there is likely to be an increased risk of the infant reacting to the cream.
* Multiple births (twins, triplets etc.) will be excluded, due to the difficulty in randomising individual twins and because of the clustering effect of multiple children from the same family which would reduce the effective sample size of the study.
* Who are born premature (<36 weeks) as the effect of the intervention may be different in premature infants.
* Who have major birth or early life medical complications that require admission into a special care nursery, as it will be difficult for parents to comply with the study requirements.
* Whose parents do not have sufficient English language skills to be able to answer questions.
* Whose parents are not able to comply with all protocol required visits and procedures
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/03/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/05/2027
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Actual
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Sample size
Target
760
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Mercy Women's Hospital - Heidelberg
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Recruitment hospital [2]
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Frances Perry Private Hospital - Parkville
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Recruitment hospital [3]
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Murdoch Children's Research Institute - Parkville
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Recruitment hospital [4]
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Royal Women's Hospital - Parkville
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment postcode(s) [2]
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3052 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a phase III, single blind (outcome assessor is blinded), randomised controlled multicentre trial of the effect of EpiCeram emollient for improving and maintaining skin barrier function and reducing incidence of eczema and food allergy in high risk infants. A total of 760 participants with a first degree family history of allergic disease (asthma, eczema, allergic rhinitis or food allergy) will be recruited (380 each group) from maternity wards of three hospitals.
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Trial website
https://clinicaltrials.gov/study/NCT03667651
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Trial related presentations / publications
Lowe A, Su J, Tang M, Lodge CJ, Matheson M, Allen KJ, Varigos G, Sasi A, Cranswick N, Hamilton S, Robertson CF, Hui J, Abramson M, O'Brien S, Dharmage S. PEBBLES study protocol: a randomised controlled trial to prevent atopic dermatitis, food allergy and sensitisation in infants with a family history of allergic disease using a skin barrier improvement strategy. BMJ Open. 2019 Mar 13;9(3):e024594. doi: 10.1136/bmjopen-2018-024594.
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Public notes
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Contacts
Principal investigator
Name
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Adrian J Lowe, Doctorate
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Address
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University of Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03667651