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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03667651




Registration number
NCT03667651
Ethics application status
Date submitted
9/09/2018
Date registered
12/09/2018
Date last updated
25/03/2020

Titles & IDs
Public title
The PEBBLES Study - Testing a Strategy for Preventing Eczema and Food Allergy in High Risk Infants
Scientific title
THE PEBBLES STUDY: A Randomised Controlled Trial to Prevent Eczema, Food Allergy and Sensitisation Using a Skin Barrier Improvement Strategy
Secondary ID [1] 0 0
ACTRN12617001380381
Secondary ID [2] 0 0
HREC/17/RCHM/221
Universal Trial Number (UTN)
Trial acronym
PEBBLES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eczema 0 0
Asthma 0 0
Allergy;Food 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of eczema - as assessed using i) the UK working party criteria for eczema and/or ii) blinded investigator observed eczema.
Timepoint [1] 0 0
12 months of age.
Primary outcome [2] 0 0
Confirmed diagnosis of food allergy at 12 months (52 weeks). - 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.
Timepoint [2] 0 0
12 months of age
Secondary outcome [1] 0 0
Eczema severity - assessed using the EASI score
Timepoint [1] 0 0
12 months of age
Secondary outcome [2] 0 0
Parent report of a community doctor diagnosis of eczema
Timepoint [2] 0 0
12 months of age
Secondary outcome [3] 0 0
infant skin barrier function - As assessed by Trans-epidermal water loss (Vapometer)
Timepoint [3] 0 0
At 6 weeks and 12 months of age
Secondary outcome [4] 0 0
Parental compliance with a program to build infant skin barrier function - as assessed by parental completion of weekly diary cards and weighing of the tubes of study cream at each visit
Timepoint [4] 0 0
At 6 weeks and 6 months of age.
Secondary outcome [5] 0 0
Adverse events - as assessed by the documentation of any untoward medical occurrence in a participant enrolled into this study
Timepoint [5] 0 0
From recruitment of infant until final study visit at 12 months of age.
Secondary outcome [6] 0 0
skin microbial colonisation, or skin lipid profile - Assessed using skin swabs at baseline, 6 weeks and 12 months of age
Timepoint [6] 0 0
At 6 weeks and 6 and 12 months of age

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
Minimum age
No limit
Maximum age
3 Weeks
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
VIC
Recruitment hospital [1] 0 0
Mercy Women's Hospital - Heidelberg
Recruitment hospital [2] 0 0
Frances Perry Private Hospital - Parkville
Recruitment hospital [3] 0 0
Murdoch Children's Research Institute - Parkville
Recruitment hospital [4] 0 0
Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03667651
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Adrian J Lowe, Doctorate
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Adrian J Lowe, Dr
Address 0 0
Country 0 0
Phone 0 0
0383440878
Fax 0 0
Email 0 0
lowea@unimelb.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03667651