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

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ClinicalTrials.gov Identifier: NCT03667651
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Adrian Lowe, University of Melbourne

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.


Condition or disease Intervention/treatment Phase
Eczema Asthma Allergy;Food Drug: EpiCeram Phase 3

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..


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A single blinded study design will be used
Masking: Single (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
Primary Purpose: Prevention
Official Title: THE PEBBLES STUDY: A Randomised Controlled Trial to Prevent Eczema, Food Allergy and Sensitisation Using a Skin Barrier Improvement Strategy
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : May 8, 2021
Estimated Study Completion Date : March 8, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: EpiCeram
Parents will be instructed to apply EpiCeram™ to the full skin surface of their child twice per day for six months.

No Intervention: Standard skin care
Parents are to follow standard skin care practices



Primary Outcome Measures :
  1. Presence of eczema [ Time Frame: 12 months of age. ]
    as assessed using i) the UK working party criteria for eczema and/or ii) blinded investigator observed eczema.

  2. Confirmed diagnosis of food allergy at 12 months (52 weeks). [ Time Frame: 12 months of age ]
    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 :
  1. Eczema severity [ Time Frame: 12 months of age ]
    assessed using the EASI score

  2. Parent report of a community doctor diagnosis of eczema [ Time Frame: 12 months of age ]
  3. infant skin barrier function [ Time Frame: At 6 weeks and 12 months of age ]
    As assessed by Trans-epidermal water loss (Vapometer)

  4. Parental compliance with a program to build infant skin barrier function [ Time Frame: At 6 weeks and 6 months of age. ]
    as assessed by parental completion of weekly diary cards and weighing of the tubes of study cream at each visit

  5. Adverse events [ Time Frame: From recruitment of infant until final study visit at 12 months of age. ]
    as assessed by the documentation of any untoward medical occurrence in a participant enrolled into this study

  6. skin microbial colonisation, or skin lipid profile [ Time Frame: At 6 weeks and 6 and 12 months of age ]
    Assessed using skin swabs at baseline, 6 weeks and 12 months of age



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667651


Contacts
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Contact: Adrian J Lowe, Dr 0383440878 lowea@unimelb.edu.au
Contact: Shaie D O'Brien, MA 0383440643 sdobrien@unimelb.edu.au

Locations
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Australia, Victoria
Mercy Women's Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Shaie O'Brien, MA    0383440643    sdobrien@unimelb.edu.au   
Contact: Arun Sasi, Dr    8458 4741    arun.sasi@mercy.com.au   
Principal Investigator: Arun Sasi, Doctorate         
Frances Perry Private Hospital Recruiting
Parkville, Victoria, Australia, 3052
Contact: Shaie O'Brien, MA    0383440643    sdobrien@unimelb.edu.au   
Contact: Shaun Brennecke, Professor    0383453700    s.brennecke@unimelb.edu.au   
Murdoch Children's Research Institute Enrolling by invitation
Parkville, Victoria, Australia, 3052
Royal Women's Hospital Recruiting
Parkville, Victoria, Australia, 3052
Contact: Shaie O'Brien    +61407528202    sdobrien@unimelb.edu.au   
Contact: Shaun Brennecke    0383453700    s.brennecke@unimelb.edu.au   
Principal Investigator: Shaun Brennecke, Prof         
Sponsors and Collaborators
University of Melbourne
Investigators
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Principal Investigator: Adrian J Lowe, Doctorate University of Melbourne

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Adrian Lowe, Dr Adrian Lowe, University of Melbourne
ClinicalTrials.gov Identifier: NCT03667651     History of Changes
Other Study ID Numbers: HREC/17/RCHM/221
ACTRN12617001380381 ( Registry Identifier: Australian New Zealand Clinical Trials Registry )
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Eczema
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Decanoic acid
Antifungal Agents
Anti-Infective Agents