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    Clinical Trial Results:
    Home Interventions and Light therapy for the treatment of vitiligo

    Summary
    EudraCT number
    		 2014-003473-42
    Trial protocol
    		 GB  
    Global end of trial date
    01 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2020
    First version publication date
    04 Jan 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    14086
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Nottingham
    Sponsor organisation address
    Lenton Lane, Nottingham, United Kingdom, NG7 2NR
    Public contact
    University of Nottingham, University of Nottingham, 0115 8467906, angela.shone@nottingham.ac.uk
    Scientific contact
    University of Nottingham, University of Nottingham, 0115 8467906, angela.shone@nottingham.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
    14 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Aug 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The priniciple research question is to compare NB-UVB light therapy to a potent topical steroid ointment, to see which treatment is safer and which treatment is more effective in improving the appearance of vitiligo. PRIMARY OBJECTIVE To assess the safety and effectiveness of: • NB-UVB light compared to potent-strength topical corticosteroid • The combination of NB-UVB light plus topical corticosteroid, compared to topical corticosteroid alone
    Protection of trial subjects
    safety data was routinely monitored by the trial team and the DMC.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2015
    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: 517
    Worldwide total number of subjects
    517
    EEA total number of subjects
    517
    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)
    0
    Children (2-11 years)
    71
    Adolescents (12-17 years)
    48
    Adults (18-64 years)
    355
    From 65 to 84 years
    43
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were identified from secondary care, primary care and through local advertising. Randomisation took place in secondary care.

    Pre-assignment
    Screening details
    		 Randomisation took place in secondary care hospitals. However, GP practices and other local hospitals in the surrounding area were approached to act as Patient Identification Centres (PICs). GP surgeries sent out invitation letters to patients who may be eligible for the trial. Potential participants were also identified through direct local advert

    Pre-assignment period milestones
    Number of subjects started
    		 517
    Number of subjects completed
    		 517

    Period 1
    Period 1 title
    baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Data analyst, Subject, Assessor
    Blinding implementation details
    Participants, research nurses, principal investigators and data analysts were blinded to treatment allocation by use of dummy UVB devices and a placebo for TCS. Only the NCTU IT Manager (who creates the treatment allocation schedule), the medical physics staff and NCTU QA staff, responsible for testing and checking the blinding of the devices, will be aware of the allocation of active / placebo treatment. Participants will be randomised by a research nurse via a randomisation website.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TCS ointment
    Arm description
    		 topical corticosteroid plus dummy hand-held NB-UVB light
    Arm type
    		 Active comparator

    Investigational medicinal product name
    TCS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    The total dosage needed by a participant over the course of the 9 month treatment phase is not expected to exceed 270g, and a procedure will be in place to capture any instances where a trial participant has requested more than this amount. Before being prescribed additional ointment, checks will be made to establish the need for additional supplies, and if necessary, a consultation with a dermatologist associated with the trial will be arranged to determine whether or not the participant is using the ointment correctly and has a genuine need for additional supplies.

    Arm title
    		 NB-UVB
    Arm description
    		 Placebo topical corticosteroid plus hand-held NB-UVB light
    Arm type
    		 Experimental

    Investigational medicinal product name
    placebo TCS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    same as active TCS

    Arm title
    		 Combination
    Arm description
    		 topical corticosteroid plus hand held NB-UVB light
    Arm type
    		 Experimental

    Investigational medicinal product name
    TCS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    The total dosage needed by a participant over the course of the 9 month treatment phase is not expected to exceed 270g, and a procedure will be in place to capture any instances where a trial participant has requested more than this amount. Before being prescribed additional ointment, checks will be made to establish the need for additional supplies, and if necessary, a consultation with a dermatologist associated with the trial will be arranged to determine whether or not the participant is using the ointment correctly and has a genuine need for additional supplies.

    Number of subjects in period 1
    		TCS ointment NB-UVB Combination
    Started
    173
    169
    175
    Completed
    173
    169
    175
    Period 2
    Period 2 title
    follow up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TCS ointment
    Arm description
    		 topical corticosteroid plus dummy hand-held NB-UVB light
    Arm type
    		 Active comparator

    Investigational medicinal product name
    TCS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    The total dosage needed by a participant over the course of the 9 month treatment phase is not expected to exceed 270g, and a procedure will be in place to capture any instances where a trial participant has requested more than this amount. Before being prescribed additional ointment, checks will be made to establish the need for additional supplies, and if necessary, a consultation with a dermatologist associated with the trial will be arranged to determine whether or not the participant is using the ointment correctly and has a genuine need for additional supplies.

    Arm title
    		 NB-UVB
    Arm description
    		 Placebo topical corticosteroid plus hand-held NB-UVB light
    Arm type
    		 Experimental

    Investigational medicinal product name
    placebo TCS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    same as active TCS

    Arm title
    		 Combination
    Arm description
    		 topical corticosteroid plus hand held NB-UVB light
    Arm type
    		 Experimental

    Investigational medicinal product name
    TCS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    The total dosage needed by a participant over the course of the 9 month treatment phase is not expected to exceed 270g, and a procedure will be in place to capture any instances where a trial participant has requested more than this amount. Before being prescribed additional ointment, checks will be made to establish the need for additional supplies, and if necessary, a consultation with a dermatologist associated with the trial will be arranged to determine whether or not the participant is using the ointment correctly and has a genuine need for additional supplies.

    Number of subjects in period 2
    		TCS ointment NB-UVB Combination
    Started
    173
    169
    175
    Completed
    119
    123
    128
    Not completed
    54
    46
    47
         Consent withdrawn by subject
    24
    17
    19
         Adverse event, non-fatal
    1
    2
    -
         Lost to follow-up
    27
    24
    24
         not assessed
    2
    3
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TCS ointment
    Reporting group description
    		 topical corticosteroid plus dummy hand-held NB-UVB light

    Reporting group title
    NB-UVB
    Reporting group description
    		 Placebo topical corticosteroid plus hand-held NB-UVB light

    Reporting group title
    Combination
    Reporting group description
    		 topical corticosteroid plus hand held NB-UVB light

    Reporting group values
    		 TCS ointment NB-UVB Combination Total
    Number of subjects
    		 173 169 175 517
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 22 22 27 71
        Adolescents (12-17 years)
    		 18 17 13 48
        Adults (18-64 years)
    		 120 115 120 355
        From 65-84 years
    		 13 15 15 43
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.6 ( 20.0 ) 36.9 ( 18.9 ) 37.0 ( 19.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 98 81 70 249
        Male
    		 75 88 105 268
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants analysed as randomised, regardless of adherence with allocated group and without imputation of missing data.

    Subject analysis set title
    modified ITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    as randomised and without imputation of missing data

    Subject analysis sets values
    		 ITT modified ITT
    Number of subjects
    517
    370
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    71
    61
        Adolescents (12-17 years)
    48
    38
        Adults (18-64 years)
    355
    234
        From 65-84 years
    43
    37
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    37.5 ( 19.3 )
    37.9 ( 20.5 )
    Gender categorical
    Units: Subjects
        Female
    249
    185
        Male
    268
    185

    End points

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    End points reporting groups
    Reporting group title
    TCS ointment
    Reporting group description
    		 topical corticosteroid plus dummy hand-held NB-UVB light

    Reporting group title
    NB-UVB
    Reporting group description
    		 Placebo topical corticosteroid plus hand-held NB-UVB light

    Reporting group title
    Combination
    Reporting group description
    		 topical corticosteroid plus hand held NB-UVB light
    Reporting group title
    TCS ointment
    Reporting group description
    		 topical corticosteroid plus dummy hand-held NB-UVB light

    Reporting group title
    NB-UVB
    Reporting group description
    		 Placebo topical corticosteroid plus hand-held NB-UVB light

    Reporting group title
    Combination
    Reporting group description
    		 topical corticosteroid plus hand held NB-UVB light

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants analysed as randomised, regardless of adherence with allocated group and without imputation of missing data.

    Subject analysis set title
    modified ITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    as randomised and without imputation of missing data

    Primary: VNS treatment success - ITT

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    End point title
    		 VNS treatment success - ITT
    End point description
    treatment success derived from VNS scale assessed at 9 months
    End point type
    Primary
    End point timeframe
    at 9 months
    End point values
    		 TCS ointment NB-UVB Combination ITT
    Number of subjects analysed
    173 [1]
    169
    175
    517
    Units: one
    20
    27
    34
    81
    Notes
    [1] - with imputation of missing data
    Statistical analysis title
    		 generalised estimating equations
    Statistical analysis description
    This is showing the first part of the complete analysis, where the comparison is UVB vs TCS.
    Comparison groups
    TCS ointment v NB-UVB
    Number of subjects included in analysis
    342
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.29
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted risk difference
    Point estimate
    0.052
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.044
         upper limit
    		 0.149
    Notes
    [2] - a minimum clinically important difference of 15% is specified
    Statistical analysis title
    		 generalised estimating equations
    Statistical analysis description
    This is to show the second part of the complete analysis for the primary outcome, where the comparison is combination VS TCS.
    Comparison groups
    TCS ointment v Combination
    Number of subjects included in analysis
    348
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.032
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted risk difference
    Point estimate
    0.109
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 0.209
    Notes
    [3] - a target difference of 15% risk difference

    Primary: VNS treatment success - modified ITT

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    End point title
    		 VNS treatment success - modified ITT
    End point description
    End point type
    Primary
    End point timeframe
    baseline to 9 months
    End point values
    		 TCS ointment NB-UVB Combination modified ITT
    Number of subjects analysed
    119
    123
    128
    370 [4]
    Units: one
    20
    27
    34
    81
    Notes
    [4] - without imputation of missing data
    Statistical analysis title
    		 generalised estimating equations
    Statistical analysis description
    without imputation of missing data at 9 months. first part of complete analysis where comparison is UVB vs TCS.
    Comparison groups
    NB-UVB v TCS ointment
    Number of subjects included in analysis
    242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.34
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted risk difference
    Point estimate
    0.043
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.045
         upper limit
    		 0.13
    Notes
    [5] - without imputation of missing data
    Statistical analysis title
    		 generalised estimating equations
    Statistical analysis description
    without imputation of missing data at 9 months. first part of complete analysis where comparison is Combination vs TCS.
    Comparison groups
    TCS ointment v Combination
    Number of subjects included in analysis
    247
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.065
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted risk difference
    Point estimate
    0.089
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.005
         upper limit
    		 0.184

    Secondary: VNS treatment success - PPI

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    End point title
    		 VNS treatment success - PPI
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to 9 months
    End point values
    		 TCS ointment NB-UVB Combination modified ITT
    Number of subjects analysed
    112 [6]
    108
    116
    336
    Units: one
    12
    22
    32
    66
    Notes
    [6] - without imputation of missing data
    Statistical analysis title
    		 generalised estimating equations
    Statistical analysis description
    without imputation of missing data at 9 months. first part of complete analysis where comparison is UVB vs TCS.
    Comparison groups
    TCS ointment v NB-UVB
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.025
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted risk difference
    Point estimate
    0.097
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.012
         upper limit
    		 0.182
    Statistical analysis title
    		 generalised estimating equations
    Statistical analysis description
    without imputation of missing data at 9 months. first part of complete analysis where comparison is Combination vs TCS.
    Comparison groups
    TCS ointment v Combination
    Number of subjects included in analysis
    228
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted risk difference
    Point estimate
    0.163
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.07
         upper limit
    		 0.256

    Secondary: Success from percentage repigmentation by blinded clinician

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    End point title
    		 Success from percentage repigmentation by blinded clinician
    End point description
    End point type
    Secondary
    End point timeframe
    9 months
    End point values
    		 TCS ointment NB-UVB Combination modified ITT
    Number of subjects analysed
    115
    116
    120
    351 [7]
    Units: one
    4
    9
    18
    31
    Notes
    [7] - without imputation of missing data
    Statistical analysis title
    		 mixed effects logistic regression
    Statistical analysis description
    for comparison UVB vs TCS
    Comparison groups
    TCS ointment v NB-UVB
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.198
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted odds ratio
    Point estimate
    2.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 7.51
    Statistical analysis title
    		 mixed effects logistic regression
    Statistical analysis description
    for comparison Combination vs TCS
    Comparison groups
    TCS ointment v Combination
    Number of subjects included in analysis
    235
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted odds ratio
    Point estimate
    4.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.5
         upper limit
    		 14.24

    Secondary: Onset of treatment response

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    End point title
    		 Onset of treatment response
    End point description
    End point type
    Secondary
    End point timeframe
    by 9 months
    End point values
    		 TCS ointment NB-UVB Combination modified ITT
    Number of subjects analysed
    141
    138
    149
    428 [8]
    Units: one
    138
    136
    145
    419
    Notes
    [8] - without imputation of missing data
    Statistical analysis title
    		 mixed effects logistic regression
    Statistical analysis description
    for comparison UVB vs TCS
    Comparison groups
    TCS ointment v NB-UVB
    Number of subjects included in analysis
    279
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.72
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted odds ratio
    Point estimate
    1.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.18
         upper limit
    		 11.62
    Statistical analysis title
    		 mixed effects logistic regression
    Statistical analysis description
    for comparison Combination vs TCS
    Comparison groups
    TCS ointment v Combination
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.907
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted odds ratio
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 28.81

    Secondary: Success from percentage repigmentation by nurse

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    End point title
    		 Success from percentage repigmentation by nurse
    End point description
    for target patch only
    End point type
    Secondary
    End point timeframe
    at 9 months
    End point values
    		 TCS ointment NB-UVB Combination modified ITT
    Number of subjects analysed
    115
    115
    119
    349 [9]
    Units: one
    10
    11
    21
    42
    Notes
    [9] - without imputation of missing data
    Statistical analysis title
    		 mixed effects logistic regression
    Statistical analysis description
    for comparison UVB vs TCS
    Comparison groups
    TCS ointment v NB-UVB
    Number of subjects included in analysis
    230
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.774
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted odds ratio
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 2.32
    Statistical analysis title
    		 mixed effects logistic regression
    Statistical analysis description
    for comparison Combination vs TCS
    Comparison groups
    TCS ointment v Combination
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.016
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted odds ratio
    Point estimate
    2.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.15
         upper limit
    		 4.15

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    between baseline and 9 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    TCS ointment
    Reporting group description
    		 -

    Reporting group title
    NB-UVB
    Reporting group description
    		 -

    Reporting group title
    Combination
    Reporting group description
    		 -

    Serious adverse events
    		 TCS ointment NB-UVB Combination
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 173 (1.16%)
    2 / 169 (1.18%)
    1 / 175 (0.57%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    injury, poisoning and procedural complication
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 169 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    nervous system disorder
         subjects affected / exposed
    0 / 173 (0.00%)
    0 / 169 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gatrointestinal disorders
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 169 (0.59%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    respiratory, thoracic and mediastinal disorder
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 169 (0.59%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    infection and infestation
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 169 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 TCS ointment NB-UVB Combination
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 173 (13.87%)
    48 / 169 (28.40%)
    52 / 175 (29.71%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    neoplasms benign, malignant and unspecified
         subjects affected / exposed
    0 / 173 (0.00%)
    2 / 169 (1.18%)
    1 / 175 (0.57%)
         occurrences all number
    0
    2
    1
    Injury, poisoning and procedural complications
    injury, poisoning and procedural
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 169 (0.00%)
    2 / 175 (1.14%)
         occurrences all number
    1
    0
    2
    Vascular disorders
    vascular disorder
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 169 (0.59%)
    3 / 175 (1.71%)
         occurrences all number
    0
    1
    3
    Nervous system disorders
    nervous system disorder
         subjects affected / exposed
    0 / 173 (0.00%)
    0 / 169 (0.00%)
    1 / 175 (0.57%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    general disorder
         subjects affected / exposed
    0 / 173 (0.00%)
    2 / 169 (1.18%)
    0 / 175 (0.00%)
         occurrences all number
    0
    2
    0
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 173 (0.00%)
    0 / 169 (0.00%)
    2 / 175 (1.14%)
         occurrences all number
    0
    0
    3
    Respiratory, thoracic and mediastinal disorders
    respiratory, thoracic and mediastinal disorder
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 169 (0.00%)
    0 / 175 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    skin and subcutaneous tissue disorder
         subjects affected / exposed
    21 / 173 (12.14%)
    45 / 169 (26.63%)
    50 / 175 (28.57%)
         occurrences all number
    29
    58
    85
    Musculoskeletal and connective tissue disorders
    musculoskeletal and connective tissue
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 169 (0.00%)
    1 / 175 (0.57%)
         occurrences all number
    1
    0
    1
    Infections and infestations
    infection and infestation
         subjects affected / exposed
    1 / 173 (0.58%)
    4 / 169 (2.37%)
    6 / 175 (3.43%)
         occurrences all number
    1
    6
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Mar 2015
    Amended Typos and added details of the MRC START sub-study; Added REC details and clinical information red the MED test; Amended so sites can add info about where the medical photography department is; Updated to allow the nurse at site to write some free text / or draw a diagram to direct the participant to their medical photography department; Updated for clarity and to reflect changes to the diary data collection
    25 Sep 2015
    Addition of four new sites to Part C of the IRAS form
    30 Sep 2015
    Inclusion and Exclusion updates; more details for treatment training, digital image analysis, allocation blinding; Changes to AE handling for erythema;
    15 Mar 2017
    Amendment to protocol to accommodate nested process evaluation and increase in trial sample size. Addition of documentation to be used for nested process evaluation. Addition of documents to aid retention.
    23 May 2017
    Change of PI at Royal Wolverhampton Trust (site 01) from Dr Seau Tak Cheung to Dr Walter Machado
    18 Jan 2018
    Changes to the protocol - Sponsor address updated - Trial Pharmacist changed - Changes have been made to document that some participants will received the study feedback and quality of life questionnaires at an earlier time point, due to shorten trial timelines. Some participants will receive these questions as part of their 15 or 18 month questionnaire (whichever is received last) as opposed to the 21 month questionnaire. - Addition of potential further output testing of some used devices. - Change to primary outcome analysis due to lower than expected retention
    26 Apr 2018
    Change of PI at site 15 Middlesbrough from Dr Robert Ellis to Dr Azad (South Tees Trust)
    16 Jul 2018
    Change of PI at site 01, Cannock, from Dr Machado to Dr Hamad (Royal Wolverhampton Trust) AND Change of PI at site 10, Derby, from Dr Batchelor to Dr Ferguson

    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.
    na
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