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    Clinical Trial Results:
    Bath Additives for the Treatment of cHildhood Eczema (BATHE)

    Summary
    EudraCT number
    		 2013-004589-32
    Trial protocol
    		 GB  
    Global end of trial date
    01 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2020
    First version publication date
    14 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    7724
    Additional study identifiers
    ISRCTN number
    		 ISRCTN84102309
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Southampton
    Sponsor organisation address
    University Rd, Southampton, United Kingdom, SO17 1BJ
    Public contact
    Dr Miriam Santer, University of Southampton, +44 02380241019, m.santer@soton.ac.uk
    Scientific contact
    Dr Miriam Santer, University of Southampton, +44 02380241019, m.santer@soton.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
    01 Mar 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Mar 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the clinical and cost-effectiveness of bath emollient treatment, in addition to standard clinical care, for childhood eczema in primary care.
    Protection of trial subjects
    None
    Background therapy
    		 Both groups continued with standard eczema management, including leave-on emollients, and caregivers were given standardised advice on how to wash participants.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 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: 483
    Worldwide total number of subjects
    483
    EEA total number of subjects
    483
    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)
    29
    Children (2-11 years)
    454
    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
    		 Recruitment took place in ninety-six general practices in Wales, the West of England, and southern England, from November 2014 to May 2016. The original target of 423 participants was reached in March 2016 and permission was obtained to continue recruiting participants up to an increased target of 491 participants.

    Pre-assignment
    Screening details
    		 Invitations were sent to the parents/carers of 12,504 children and responses were received from 1451. There were 920 completed screening questionnaire and 662 children met eligibility criteria and were approached regarding participation.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open trial, as it is not possible to create a convincing placebo for bath additives, with a primary outcome measure that was participant reported, as our main concern was with the impact of symptoms.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard management with bath additive
    Arm description
    		 In addition to the child’s usual skincare regimen, parents/carers were asked to use one of the three most commonly used bath additives Balneum, Aveeno, or Oilatum at least once per week, in accordance with the manufacturer’s instructions.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Balneum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Bath additive
    Routes of administration
    Other use
    Dosage and administration details
    At least once per week, in accordance with the manufacturer’s instructions.

    Investigational medicinal product name
    Aveeno
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Bath additive
    Routes of administration
    Other use
    Dosage and administration details
    At least once per week, in accordance with the manufacturer’s instructions.

    Investigational medicinal product name
    Oilatum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Bath additive
    Routes of administration
    Other use
    Dosage and administration details
    At least once per week, in accordance with the manufacturer’s instructions.

    Arm title
    		 Standard management, no bath additive
    Arm description
    		 The standard management of eczema in children without using bath emollient
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Standard management with bath additive Standard management, no bath additive
    Started
    265
    218
    Completed
    264
    218
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard management with bath additive
    Reporting group description
    		 In addition to the child’s usual skincare regimen, parents/carers were asked to use one of the three most commonly used bath additives Balneum, Aveeno, or Oilatum at least once per week, in accordance with the manufacturer’s instructions.

    Reporting group title
    Standard management, no bath additive
    Reporting group description
    		 The standard management of eczema in children without using bath emollient

    Reporting group values
    		 Standard management with bath additive Standard management, no bath additive Total
    Number of subjects
    		 265 218 483
    Age categorical
    Units: Subjects
        Children between 1 year and 12 years
    		 265 218 483
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 5.4 ± 2.9 5.2 ± 2.9 -
    Gender categorical
    Units: Subjects
        Female
    		 138 100 238
        Male
    		 127 118 245
    Patient Oriented Eczema Measure (POEM)
    Units: score
        arithmetic mean (standard deviation)
    		 9.5 ± 5.7 10.1 ± 5.8 -

    End points

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    End points reporting groups
    Reporting group title
    Standard management with bath additive
    Reporting group description
    		 In addition to the child’s usual skincare regimen, parents/carers were asked to use one of the three most commonly used bath additives Balneum, Aveeno, or Oilatum at least once per week, in accordance with the manufacturer’s instructions.

    Reporting group title
    Standard management, no bath additive
    Reporting group description
    		 The standard management of eczema in children without using bath emollient

    Primary: Patient Oriented Eczema Measure (POEM) at 16 weeks

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    End point title
    		 Patient Oriented Eczema Measure (POEM) at 16 weeks
    End point description
    End point type
    Primary
    End point timeframe
    16 weeks
    End point values
    		 Standard management with bath additive Standard management, no bath additive
    Number of subjects analysed
    264 [1]
    218
    Units: score
        arithmetic mean (standard deviation)
    7.1 ± 6.1
    8.2 ± 6.3
    Notes
    [1] - 1 participant withdraw data
    Statistical analysis title
    		 Patient Oriented Eczema Measure (POEM) week 16
    Statistical analysis description
    Interaction between treatment and time 0 to 16 weeks
    Comparison groups
    Standard management with bath additive v Standard management, no bath additive
    Number of subjects included in analysis
    482
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.204 [2]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [2] - The primary analysis for the total POEM score was performed using a mixed multilevel model (MMLM) framework, with observations over time from weeks 1 to 16 (level 1) nested within participants (level 2) nested within recruiting centres (level 3).

    Secondary: Number of eczema exacerbations resulting in a primary health-care consultation

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    End point title
    		 Number of eczema exacerbations resulting in a primary health-care consultation
    End point description
    The number of eczema exacerbations resulting in a primary health-care consultation, assessed by a review of participants’ primary care records. Notes reviews were carried out by members of the trial team.
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 Standard management with bath additive Standard management, no bath additive
    Number of subjects analysed
    265
    218
    Units: number of exacerbations
        median (inter-quartile range (Q1-Q3))
    1 (0 to 2)
    1 (0 to 3)
    Statistical analysis title
    		 Number of exacerbation
    Statistical analysis description
    Adjusted
    Comparison groups
    Standard management, no bath additive v Standard management with bath additive
    Number of subjects included in analysis
    483
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.6

    Secondary: Health-related quality of life_Utility values (CHU-9D)

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    End point title
    		 Health-related quality of life_Utility values (CHU-9D)
    End point description
    Child Health Utility-9 Dimensions captures issues pertinent to childhood eczema, such as sleep disturbance and the child’s mood.
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 Standard management with bath additive Standard management, no bath additive
    Number of subjects analysed
    177
    150
    Units: score
        arithmetic mean (standard deviation)
    0.9 ± 0.1
    0.91 ± 0.1
    Statistical analysis title
    		 Utility values (CHU-9D)
    Comparison groups
    Standard management with bath additive v Standard management, no bath additive
    Number of subjects included in analysis
    327
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0.01

    Secondary: Health-related quality of life_QALYs

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    End point title
    		 Health-related quality of life_QALYs
    End point description
    Reporting quality-adjusted life-years were estimated using the paediatric QoL measure CHU-9D.
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 Standard management with bath additive Standard management, no bath additive
    Number of subjects analysed
    174
    147
    Units: score
        median (standard deviation)
    0.91 ± 0.1
    0.90 ± 0.1
    Statistical analysis title
    		 QALYs
    Comparison groups
    Standard management with bath additive v Standard management, no bath additive
    Number of subjects included in analysis
    321
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.02

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    52 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Standard management with bath additive
    Reporting group description
    		 In addition to the child’s usual skincare regimen, parents/carers were asked to use one of the three most commonly used bath additives Balneum, Aveeno, or Oilatum at least once per week, in accordance with the manufacturer’s instructions.

    Reporting group title
    Standard management, no bath additive
    Reporting group description
    		 The standard management of eczema in children without using bath emollient

    Serious adverse events
    		 Standard management with bath additive Standard management, no bath additive
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 218 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Standard management with bath additive Standard management, no bath additive
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    137 / 265 (51.70%)
    159 / 218 (72.94%)
    Investigations
    Refuses a bath
         subjects affected / exposed
    30 / 265 (11.32%)
    31 / 218 (14.22%)
         occurrences all number
    30
    31
    Injury, poisoning and procedural complications
    Slips
         subjects affected / exposed
    56 / 265 (21.13%)
    63 / 218 (28.90%)
         occurrences all number
    56
    63
    Skin and subcutaneous tissue disorders
    Stinging
         subjects affected / exposed
    7 / 265 (2.64%)
    4 / 218 (1.83%)
         occurrences all number
    7
    4
    Redness
         subjects affected / exposed
    44 / 265 (16.60%)
    61 / 218 (27.98%)
         occurrences all number
    44
    61

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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/30362939
    http://www.ncbi.nlm.nih.gov/pubmed/29724749
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