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The PEBBLES Study - Testing a Strategy for Preventing Eczema and Food Allergy in High Risk Infants (PEBBLES)

Primary Purpose

Eczema, Asthma, Allergy;Food

Status
Active
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
EpiCeram
Sponsored by
University of Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eczema

Eligibility Criteria

undefined - 3 Weeks (Child)All SexesAccepts Healthy Volunteers

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

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

Sites / Locations

  • Mercy Women's Hospital
  • Frances Perry Private Hospital
  • Murdoch Children's Research Institute
  • Royal Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Twice daily use treatment with EpiCeram

Standard skin care

Arm Description

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.

Parents are to follow standard skin care practices

Outcomes

Primary Outcome Measures

Presence of eczema
as assessed using i) the UK working party criteria for eczema and/or ii) blinded investigator observed eczema.
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.

Secondary Outcome Measures

Eczema severity
assessed using the EASI score
Parent report of a community doctor diagnosis of eczema
infant skin barrier function
As assessed by Trans-epidermal water loss (Vapometer)
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
Adverse events
as assessed by the documentation of any untoward medical occurrence in a participant enrolled into this study
skin microbial colonisation, or skin lipid profile
Assessed using skin swabs at baseline, 6 weeks and 12 months of age

Full Information

First Posted
September 9, 2018
Last Updated
May 9, 2023
Sponsor
University of Melbourne
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1. Study Identification

Unique Protocol Identification Number
NCT03667651
Brief Title
The PEBBLES Study - Testing a Strategy for Preventing Eczema and Food Allergy in High Risk Infants
Acronym
PEBBLES
Official Title
THE PEBBLES STUDY: A Randomised Controlled Trial to Prevent Eczema, Food Allergy and Sensitisation Using a Skin Barrier Improvement Strategy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
May 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Melbourne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The primary objective of this study is to demonstrate that twice daily application of a ceramide dominant emollient reduces the risk of eczema and food allergy, when compared to standard skin management. Secondary objectives are to determine if twice daily application of a ceramide dominant emollient reduces the risk of infants developing allergic sensitisation (as measured by skin prick test); to determine if twice daily application of a ceramide dominant emollient improves infant skin barrier function; to determine the level of parental compliance with a program to build infant skin barrier function; to confirm that a ceramide dominant emollient does not cause adverse effects in infants; to determine the level of compliance required to demonstrate an improvement in infant skin barrier function and to determine if twice daily application of a ceramide dominant emollient influences infant skin microbial colonisation, or skin lipid profile. 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. Treatment will be from birth until six months, with a six week, six month and twelve month follow-up. An initial assessment will be performed at baseline which incorporates three surveys, a skin assessment, diary card (which is to be completed weekly and measures compliance), a breast milk sample, guthrie card and tape stripping. The six week and six month assessments entail a skin assessment, survey, compliance check, breast milk sample, tape stripping and guthrie card. Primary outcomes are assessed at the 12 month follow up where in addition to the aforementioned items, a saliva sample will also be taken and skin prick testing and food challenges will be performed when children have a positive SPT to one or more foods..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema, Asthma, Allergy;Food

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A single blinded study design will be used
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will be blinded to the group of allocation and will have no contact with the participants aside from the assessment of outcomes at six-weeks and 12-months
Allocation
Randomized
Enrollment
760 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Twice daily use treatment with EpiCeram
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard skin care
Arm Type
No Intervention
Arm Description
Parents are to follow standard skin care practices
Intervention Type
Drug
Intervention Name(s)
EpiCeram
Intervention Description
Parents will be instructed to apply EpiCeram™ to the full skin surface of their child twice per day for six months.
Primary Outcome Measure Information:
Title
Presence of eczema
Description
as assessed using i) the UK working party criteria for eczema and/or ii) blinded investigator observed eczema.
Time Frame
12 months of age.
Title
Confirmed diagnosis of food allergy at 12 months (52 weeks).
Description
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.
Time Frame
12 months of age
Secondary Outcome Measure Information:
Title
Eczema severity
Description
assessed using the EASI score
Time Frame
12 months of age
Title
Parent report of a community doctor diagnosis of eczema
Time Frame
12 months of age
Title
infant skin barrier function
Description
As assessed by Trans-epidermal water loss (Vapometer)
Time Frame
At 6 weeks and 12 months of age
Title
Parental compliance with a program to build infant skin barrier function
Description
as assessed by parental completion of weekly diary cards and weighing of the tubes of study cream at each visit
Time Frame
At 6 weeks and 6 months of age.
Title
Adverse events
Description
as assessed by the documentation of any untoward medical occurrence in a participant enrolled into this study
Time Frame
From recruitment of infant until final study visit at 12 months of age.
Title
skin microbial colonisation, or skin lipid profile
Description
Assessed using skin swabs at baseline, 6 weeks and 12 months of age
Time Frame
At 6 weeks and 6 and 12 months of age

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian J Lowe, Doctorate
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Women's Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Frances Perry Private Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Murdoch Children's Research Institute
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Royal Women's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30867201
Citation
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.
Results Reference
derived

Learn more about this trial

The PEBBLES Study - Testing a Strategy for Preventing Eczema and Food Allergy in High Risk Infants

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