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    Clinical Trial Results:
    Choice Of Moisturiser in Eczema Treatment (COMET): A feasibility study of pragmatic, single blind, randomised clinical trial to compare the clinical and cost effectiveness of leave-on emollients in treatment of infant eczema in primary care

    Summary
    EudraCT number
    		 2013-003001-26
    Trial protocol
    		 GB  
    Global end of trial date
    31 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jul 2018
    First version publication date
    01 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2009
    Additional study identifiers
    ISRCTN number
    		 ISRCTN21828118
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 NIHR RfPB: PB-PG-0712-28056, NIHR Portfolio: 134716, NHS REC: 13/SW/0297
    Sponsors
    Sponsor organisation name
    University of Bristol
    Sponsor organisation address
    Senate House, Tyndall Avenue, Bristol, United Kingdom, BS8 1TH
    Public contact
    Birgit Whitman, University of Bristol, +44 01173317130, birgit.whitman@bristol.ac.uk
    Scientific contact
    Birgit Whitman, University of Bristol, +44 01173317130, birgit.whitman@bristol.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal research question for this feasibility study: Is it possible to recruit and retain participants from primary care into a four arm randomised control trial of emollients in children with eczema aged between 1 month and 5 years? The principal research question for the main trial: "Which is the most clinically and cost effective primary emollient to use in infants with eczema?"
    Protection of trial subjects
    The trial was conducted in compliance with the principles of the Declaration of Helsinki (1996), the principles of GCP and in accordance with all applicable regulatory requirements including but not limited to the Research Governance Framework and the Medicines for Human Use (Clinical Trial) Regulations 2004, as amended in 2006 and any subsequent amendments. This protocol and related documents were reviewed by NRES Committee South West - Central Bristol Research Ethics (REC), and given Clinical Trial Authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA). An adult with parental responsibility gave written consent for the child to take part. The study was classified as a low risk (type A) medicines trial because participants were randomised to treatments that can be both bought over-the-counter and are prescribed on a daily basis. The conduct of the study and the safety of participants were monitored by an independent Trial Steering/Data Monitoring Committee.
    Background therapy
    		 All participants were allocated a study emollient. The study did not include a control arm, as it might be considered unethical to randomise a child with eczema to no emollient.
    Evidence for comparator
    		 Participants were randomly allocated to one of four emollients (Aveeno® lotion, Diprobase® cream, Doublebase® gel, Hydromol® ointment) to use as their primary leave-on emollient with directions to ‘Use twice daily and when required.’ These were chosen because they represent each of the different formulations (lotion, cream, gel and ointment), are among the most commonly prescribed and vary in cost. In addition, Doublebase® and Diprobase® emerged as the most popular in a patient preference study and mechanistic studies have shown that these emollients enhance skin barrier function.
    Actual start date of recruitment
    03 Feb 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 197
    Worldwide total number of subjects
    197
    EEA total number of subjects
    197
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    123
    Children (2-11 years)
    74
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between July 2014 and April 2015, participants were recruited in primary care (general practice) via two pathways: ‘self-referral’ (usually in response to a letter sent by their practice inviting them to take part) or ‘in consultation’ (an approach during a surgery visit by GP/practice nurse, who also received consent and undertook randomisation).

    Pre-assignment
    Screening details
    		 GP searched their medical records for registered patients aged > 1 to <35 months with an eczema Read code; and screened the results excluding children: who no longer have eczema; known to be sensitive to one of the study emollients; whose parents unable to complete questionnaires; with adverse medical or social circumstances; or for other reasons.

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    The Clinical Study Officer (CSO) was masked to the participant’s treatment allocation: they had restricted access to the randomisation system meaning they could not identify which emollient had been assigned to which participant; and parents were asked not to disclose which treatment they are using, to hide the emollient container from view, and to maximise the amount of time between emollient application and the assessments taking place.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lotion
    Arm description
    		 Aveeno lotion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Aveeno lotion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Cutaneous use
    Dosage and administration details
    No maximum dose Cutaneous use

    Arm title
    		 Cream
    Arm description
    		 Diprobase cream
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diprobase Cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    No maximum dosage. Cutaneous use

    Arm title
    		 Gel_
    Arm description
    		 Doublebase gel
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Doublebase gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    No maximum dose. Cutaneous use.

    Arm title
    		 Ointment
    Arm description
    		 Hydromol ointment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hydromol ointment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use
    Dosage and administration details
    No maximum dose. Cutaneous use

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Only the observer was blinded; clinicians and parents/children taking part in the trial knew their allocation.
    Number of subjects in period 1
    		Lotion Cream Gel_ Ointment
    Started
    51
    53
    46
    47
    Completed
    39
    39
    39
    34
    Not completed
    12
    14
    7
    13
         Lost to follow-up
    12
    14
    7
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lotion
    Reporting group description
    		 Aveeno lotion

    Reporting group title
    Cream
    Reporting group description
    		 Diprobase cream

    Reporting group title
    Gel_
    Reporting group description
    		 Doublebase gel

    Reporting group title
    Ointment
    Reporting group description
    		 Hydromol ointment

    Reporting group values
    		 Lotion Cream Gel_ Ointment Total
    Number of subjects
    		 51 53 46 47 197
    Age categorical
    Age in months
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 30 29 30 34 123
        Children (2-11 years)
    		 21 24 16 13 74
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 17 26 19 23 85
        Male
    		 34 27 27 24 112
    POEM
    Patient Orientated Eczema Measure
    Units: unit(s)
        arithmetic mean (standard deviation)
    		 8.3 ( 5.9 ) 8.5 ( 6.5 ) 9.7 ( 5.4 ) 8.8 ( 5.7 ) -
    EASI
    Eczema Area Severity Index
    Units: unit(s)
        arithmetic mean (standard deviation)
    		 2.8 ( 3.6 ) 3.5 ( 4.1 ) 2.7 ( 4.2 ) 2.7 ( 3.3 ) -

    End points

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    End points reporting groups
    Reporting group title
    Lotion
    Reporting group description
    		 Aveeno lotion

    Reporting group title
    Cream
    Reporting group description
    		 Diprobase cream

    Reporting group title
    Gel_
    Reporting group description
    		 Doublebase gel

    Reporting group title
    Ointment
    Reporting group description
    		 Hydromol ointment

    Primary: POEM

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    End point title
    		 POEM [1]
    End point description
    12 week follow-up questionnaire
    End point type
    Primary
    End point timeframe
    84 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a feasibility trial so no a priori primary outcome was specified.
    End point values
    		 Lotion Cream Gel_ Ointment
    Number of subjects analysed
    36
    38
    37
    31
    Units: unit(s)
        arithmetic mean (standard deviation)
    3.7 ( 3.9 )
    5.2 ( 4.4 )
    3.9 ( 4.8 )
    4.4 ( 5.7 )
    No statistical analyses for this end point

    Secondary: EASI

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    End point title
    		 EASI
    End point description
    3 month follow-up visit
    End point type
    Secondary
    End point timeframe
    84 days
    End point values
    		 Lotion Cream Gel_ Ointment
    Number of subjects analysed
    39
    39
    38
    32
    Units: unit(s)
        arithmetic mean (standard deviation)
    1.3 ( 1.6 )
    2.5 ( 2.9 )
    1.8 ( 5.3 )
    2.2 ( 2.9 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    3 months
    Adverse event reporting additional description
    Adverse events were collected by means of a patient-completed diary; serious adverse events were reported directly to the trial team and the trial sponsor notified.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 No dictionary
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Lotion
    Reporting group description
    		 Aveeno lotion

    Reporting group title
    Cream
    Reporting group description
    		 Diprobase cream

    Reporting group title
    Gel_
    Reporting group description
    		 Doublebase gel

    Reporting group title
    Ointment
    Reporting group description
    		 Hydromol ointment

    Serious adverse events
    		 Lotion Cream Gel_ Ointment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Skin infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Lotion Cream Gel_ Ointment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 51 (50.98%)
    30 / 53 (56.60%)
    30 / 46 (65.22%)
    28 / 47 (59.57%)
    Skin and subcutaneous tissue disorders
    All skin reactions
    Additional description: Any of pruritis, rash, erythema, pain, dry skin or infection
         subjects affected / exposed
    26 / 51 (50.98%)
    30 / 53 (56.60%)
    30 / 46 (65.22%)
    28 / 47 (59.57%)
         occurrences all number
    107
    90
    89
    71

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Aug 2014
    Clarifying the adverse and serious adverse events that would be expected to be seen within the normal population of children within this age group; and the way we capture the information regarding AEs and SAEs.
    06 Dec 2014
    In addition to GCP-trained doctors, appropriately qualified health care professional who are GCP trained (with oversight from a medically qualified doctor) able to confirm eligibility. Change of eligibility criteria from "child aged between 1 month to 3 years with doctor diagnosed eczema" to "child aged between 1 month and 5 years of age with eczema (diagnosed by a doctor or an appropriately qualified health care professional with oversight from a medically qualified doctor)” Seeking to recruit children from an additional 14 general practices (so total of 30 practices), with only the first 16 practices doing the follow-up mail-outs. Distinction in interval between referral and baseline assessment between participants who enter the study via GP/PN and those who self-refer.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27852708
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