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    Clinical Trial Results:
    A randomized, open-label, comparative study to evaluate an intermittent dosing regimen of fluticasone propionate 0.05% cream (twice per week) in reducing the risk of relapse when added to regular daily moisturization using Physiogel® Lotion in paediatric subjects with stabilized atopic dermatitis

    Summary
    EudraCT number
    		 2017-001574-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Oct 2017
    First version publication date
    21 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    117291
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the risk of AD relapse can be significantly reduced by extended intermittent dosing with Fluticasone propionate 0.05% cream in addition to regular emollient therapy in the maintenance treatment (20 weeks) of atopic dermatitis as compared with application of physiogel lotion alone.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Dec 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 123
    Worldwide total number of subjects
    123
    EEA total number of subjects
    0
    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)
    6
    Children (2-11 years)
    115
    Adolescents (12-17 years)
    2
    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
    		 Number of enrolled participants n=123 in Acute Phase and n=107 in Maintenance Phase (ITT Population).

    Pre-assignment
    Screening details
    		 Eligible participants (par.) received twice daily (BID) fluticasone propionate 0.05% (FP) cream up to 4 weeks (wk) (in Acute Phase), then par. received (1:1) either emollient BID plus FP cream once daily (OD) twice a wk, or emollient BID up to 20 wk (Maintenance Phase). Par. who did not relapse received emollient BID up to 12 wk (Follow-up Phase).

    Period 1
    Period 1 title
    Acute Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 FP 0.05% cream
    Arm description
    		 Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone proprionate (FP) 0.05%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    All participants in ACUTE phase were administered FP 0.05% cream twice daily treatment. In MAINTENANCE phase, randomized participants were given FP 0.05% cream once daily twice a week. FP 0.05% cream was applied to all healed sites and any newly occurring sites.

    Number of subjects in period 1
    		FP 0.05% cream
    Started
    123
    Completed–not entered Maintenance Phase
    4 [1]
    Completed
    111
    Not completed
    12
         Physician decision
    1
         ACCEPTED OTHER TOPIC THERAPIES
    1
         NOT ACHIEVED "TREATMENT SUCCESS"
    1
         Lost to follow-up
    4
         Missing
    1
         Withdrawal by subject
    4
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone is included to state that 4 participants completed the acute phase but did not enter the maintenance phase.
    Period 2
    Period 2 title
    Maintenance Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Emollient plus FP 0.05% cream
    Arm description
    		 Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Emollient
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Emollient twice daily was applied before application of FP 0.05% cream to the affected and unaffected areas in MAINTENANCE phase and FOLLOW-UP phase.

    Investigational medicinal product name
    Fluticasone proprionate (FP) 0.05%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    All participants in ACUTE phase were administered FP 0.05% cream twice daily treatment. In MAINTENANCE phase, randomized participants were given FP 0.05% cream once daily twice a week. FP 0.05% cream was applied to all healed sites and any newly occurring sites.

    Arm title
    		 Emollient
    Arm description
    		 Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Emollient
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Emollient twice daily was applied before application of FP 0.05% cream to the affected and unaffected areas in MAINTENANCE phase and FOLLOW-UP phase.

    Number of subjects in period 2 [2]
    		Emollient plus FP 0.05% cream Emollient
    Started
    54
    53
    Completed
    48
    51
    Not completed
    6
    2
         Lost to follow-up
    4
    1
         Missing
    1
    -
         Withdrawal by subject
    1
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Four participants had completed the acute phase but did not enter the maintenance phase.
    Period 3
    Period 3 title
    Follow-up Phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Follow-up: Emollient
    Arm description
    		 Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Emollient
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Emollient twice daily was applied before application of FP 0.05% cream to the affected and unaffected areas in MAINTENANCE phase and FOLLOW-UP phase.

    Number of subjects in period 3 [3]
    		Follow-up: Emollient
    Started
    66
    Completed
    64
    Not completed
    2
         Physician decision
    1
         Withdrawal by subject
    1
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Forty-one participants had atopic dermatitis relapse hence could not enter the follow-up phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Acute Phase
    Reporting group description
    		 Acute Phase

    Reporting group values
    		 Acute Phase Total
    Number of subjects
    		 123
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 4.8 ( 2.58 ) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 63 63
        Male
    		 60 60
    Race/Ethnicity, Customized
    Units: Subjects
        Chinese
    		 118 118
        Other
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    FP 0.05% cream
    Reporting group description
    		 Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
    Reporting group title
    Emollient plus FP 0.05% cream
    Reporting group description
    		 Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.

    Reporting group title
    Emollient
    Reporting group description
    		 Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
    Reporting group title
    Follow-up: Emollient
    Reporting group description
    		 Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.

    Primary: Time to the first relapse of AD during the Maintenance Phase

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    End point title
    		 Time to the first relapse of AD during the Maintenance Phase
    End point description
    Time to the first relapse of AD is defined as the number of days from start of the FP treatment in Maintenance Phase until AD relapse. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success during Acute Phase. Participants with treatment success are defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline. 99999 indicates that data were not available. ITT Population: all participants who were randomized into the Maintenance Phase. Only participants available at the specified time point were analyzed.
    End point type
    Primary
    End point timeframe
    From the start of treatment up to Week 20 during the Maintenance Phase
    End point values
    		 Emollient plus FP 0.05% cream Emollient
    Number of subjects analysed
    54 [1]
    53 [2]
    Units: Days
        median (confidence interval 95%)
    99999 (-99999 to 99999)
    142.0 (50.0 to 150.0)
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Emollient plus FP 0.05% cream v Emollient
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    13.4993
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.1113
         upper limit
    		 44.325

    Secondary: Median time to the first relapse of AD during the Maintenance Phase and Follow-up Phase

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    End point title
    		 Median time to the first relapse of AD during the Maintenance Phase and Follow-up Phase
    End point description
    Median time to the first relapse of AD during the Maintenance Phase and Follow-up Phase is defined as the number of days from start of the FP treatment until AD relapse during the Maintenance Phase and Follow-up Phase. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success during the Acute Phase. 99999 indicates that data were not available.
    End point type
    Secondary
    End point timeframe
    From the start of treatment up to Week 32 during the Maintenance Phase and Follow-up Phase
    End point values
    		 Emollient plus FP 0.05% cream Emollient
    Number of subjects analysed
    54 [3]
    53 [4]
    Units: Days
        median (confidence interval 95%)
    99999 (-99999 to 99999)
    142.0 (50.0 to 99999)
    Notes
    [3] - ITT Population. Only participants available at the specified time point were analyzed.
    [4] - ITT Population. Only participants available at the specified time point were analyzed.
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Emollient plus FP 0.05% cream v Emollient
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    4.9524
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.4258
         upper limit
    		 10.1105

    Secondary: Numbers of recurrent participants at the end of the Maintenance Phase (Week 20)

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    End point title
    		 Numbers of recurrent participants at the end of the Maintenance Phase (Week 20)
    End point description
    The number of participants with AD recurrent/relapse at the end of Maintenance Phase is presented. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success. Participants with treatment success is defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.
    End point type
    Secondary
    End point timeframe
    From Week 0 (or treatment success, if earlier) to Week 20
    End point values
    		 Emollient plus FP 0.05% cream Emollient
    Number of subjects analysed
    54 [5]
    53 [6]
    Units: Participants
    3
    30
    Notes
    [5] - ITT Population
    [6] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Emollient plus FP 0.05% cream v Emollient
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Fisher exact
    Confidence interval
         level
    		 95%

    Secondary: Numbers of recurrent participants at the end of the Follow-up Phase (Week 32)

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    End point title
    		 Numbers of recurrent participants at the end of the Follow-up Phase (Week 32)
    End point description
    The number of participants with AD recurrent/relapse at the end of the Follow-up Phase is presented. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success. Participants with treatment success is defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.
    End point type
    Secondary
    End point timeframe
    From Week 20 to Week 32
    End point values
    		 Emollient plus FP 0.05% cream Emollient
    Number of subjects analysed
    54 [7]
    53 [8]
    Units: Participants
    10
    32
    Notes
    [7] - ITT Population
    [8] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Emollient plus FP 0.05% cream v Emollient
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Chi-squared
    Confidence interval
         level
    		 95%

    Secondary: Number of participants with “treatment success” during the Acute Phase

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    End point title
    		 Number of participants with “treatment success” during the Acute Phase
    End point description
    The number of participants with "treatment success” during the Acute Phase is presented. Participants with treatment success are defined as participants with PSGA <=1; and the improvement >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to Baseline in the Acute Phase of the study.
    End point type
    Secondary
    End point timeframe
    From the start of treatment up to Visit 4 (Week 0) or treatment success (depends on which time point comes first)
    End point values
    		 FP 0.05% cream
    Number of subjects analysed
    123 [9]
    Units: Participants
    107
    Notes
    [9] - Enrolled Population: all participants who were enrolled into the Acute Phase of the study.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Quality of Life (QoL) at the end of the Maintenance Phase

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    End point title
    		 Change from Baseline in Quality of Life (QoL) at the end of the Maintenance Phase
    End point description
    Infant's Dermatitis Quality of Life Index (IDQOL) and Children's Dermatology Life Quality Index (CDLQI) were used to evaluate quality of life for participants of age between 1 to 16 years. IDQOL and CDLQI questionnaires were designed for infants (below the age of 4 years) and children (age 4 to age 16) with atopic dermatitis, respectively. The IDQOL and CDLQI were calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. The change from Baseline in the QoL score is based on each questionnaire at the end of the Maintenance Phase and is calculated as the score at the end of the Maintenance Phase minus the Baseline score. Baseline is defined as QoL scores obtained at Visit 4 (end of Acute Phase). A QOL is equal to IDQOL if the age of a participant is < 4 years and it is equal to CDLQI if the age of a participant is between 4 and 16 years.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 20
    End point values
    		 Emollient plus FP 0.05% cream Emollient
    Number of subjects analysed
    54 [10]
    53 [11]
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -0.4 ( 4.40 )
    2.2 ( 4.68 )
    Notes
    [10] - ITT Population
    [11] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Emollient plus FP 0.05% cream v Emollient
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%

    Secondary: Change from Baseline in QoL at the end of the Follow-up Phase

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    End point title
    		 Change from Baseline in QoL at the end of the Follow-up Phase
    End point description
    Infant's IDQOL and Children's CDLQI were used to evaluate quality of life for participants of age between 1 to 16 years. IDQOL and CDLQI questionnaires were designed for infants (below the age of 4 years) and children (age 4 to age 16) with AD, respectively. The IDQOL and CDLQI were calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. The change from Baseline in QoL score is based on each questionnaire at the end of the Follow-up Phase and is calculated as the score at the end of the Follow-up Phase minus the Baseline score. Baseline is defined as QoL scores obtained at Visit 4 (end of Acute Phase). A QOL is equal to IDQOL if the age of a participant is < 4 years and it is equal to CDLQI if the age of a participant is between 4 and 16 years.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 32
    End point values
    		 Emollient plus FP 0.05% cream Emollient
    Number of subjects analysed
    54 [12]
    53 [13]
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    0.0 ( 4.97 )
    2.2 ( 5.10 )
    Notes
    [12] - ITT Population
    [13] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Emollient plus FP 0.05% cream v Emollient
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%

    Secondary: Number of participants with post-study assessment of skin emollients using questionnaire

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    End point title
    		 Number of participants with post-study assessment of skin emollients using questionnaire
    End point description
    Participants from each group completed the post-study questionnaire to rate the skin emollients (gel, lotion, cream, ointment, solution and foam) used in the past based on their experience. Participants rated skin emollients on a 5-point scale (5= “liked the best”, 4= “second best”, 3= “third best”, 2= “fourth best, 1= “liked the least”, N/A=Does not apply to me).
    End point type
    Secondary
    End point timeframe
    At early withdrawal or end of the therapy visit (up to Week 32)
    End point values
    		 Emollient plus FP 0.05% cream Emollient
    Number of subjects analysed
    54 [14]
    53 [15]
    Units: Participants
        Gel, 1
    2
    1
        Gel, 2
    2
    1
        Gel, 3
    2
    2
        Gel, 4
    2
    2
        Gel, 5
    1
    0
        Gel, N/A
    39
    44
        Lotion, 1
    1
    1
        Lotion, 2
    0
    1
        Lotion, 3
    7
    2
        Lotion, 4
    8
    12
        Lotion, 5
    27
    26
        Lotion, N/A
    5
    8
        Cream, 1
    1
    0
        Cream, 2
    1
    2
        Cream, 3
    7
    2
        Cream, 4
    12
    18
        Cream, 5
    6
    5
        Cream, N/A
    21
    23
        Ointment, 1
    1
    3
        Ointment, 2
    7
    3
        Ointment, 3
    5
    10
        Ointment, 4
    3
    3
        Ointment, 5
    10
    11
        Ointment, N/A
    22
    20
        Solution, 1
    0
    1
        Solution, 2
    1
    0
        Solution, 3
    4
    5
        Solution, 4
    4
    2
        Solution, 5
    1
    0
        Solution, N/A
    38
    42
        Foam, 1
    4
    2
        Foam, 2
    1
    1
        Foam, 3
    1
    0
        Foam, 4
    0
    0
        Foam, 5
    0
    0
        Foam, N/A
    42
    47
    Notes
    [14] - ITT Population
    [15] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with post-study assessment of lotion qualities (1) using questionnaire

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    End point title
    		 Number of participants with post-study assessment of lotion qualities (1) using questionnaire
    End point description
    Participants from each group completed the post-study questionnaire to rate the qualities of the lotion as compared with other skin emollients used in the past based on their experience. Each participant was asked the following Questions (Q). Q 1: This product is easier to use than other skin emollients; Q 2: When I apply this product I am able to start my daily activities quicker than with other skin emollients; Q 3: This product leaves my skin feeling softer than other skin emollients; Q 4: I am able to apply this product to larger body surface areas than other skin emollients; Q 5: This product disappears into my skin quicker than when I apply other skin emollients. Participants rated the qualities of the lotion based on a 5 point scale (5= “Strongly Agree”, 4= “Agree”, 3= “Neutral”, 2= “Disagree", 1= “Strongly Disagree” N/A=Does not apply to me). Participant's rating for each question were summarized.
    End point type
    Secondary
    End point timeframe
    At early withdrawal or end of the therapy visit (up to Week 32)
    End point values
    		 Emollient plus FP 0.05% cream Emollient
    Number of subjects analysed
    54 [16]
    53 [17]
    Units: Participants
        Q 1, 1
    0
    0
        Q 1, 2
    0
    4
        Q 1, 3
    5
    13
        Q 1, 4 or 5
    39
    29
        Q 1, N/A
    4
    4
        Q 2, 1
    0
    1
        Q 2, 2
    1
    2
        Q 2, 3
    5
    13
        Q 2, 4 or 5
    38
    29
        Q 2, N/A
    4
    5
        Q 3, 1
    0
    0
        Q 3, 2
    1
    3
        Q 3, 3
    4
    9
        Q 3, 4 or 5
    39
    34
        Q 3, N/A
    4
    4
        Q 4, 1
    0
    1
        Q 4, 2
    0
    1
        Q 4, 3
    6
    7
        Q 4, 4 or 5
    38
    37
        Q 4, N/A
    4
    4
        Q 5, 1
    0
    2
        Q 5, 2
    0
    2
        Q 5, 3
    6
    10
        Q 5, 4 or 5
    38
    32
        Q 5, N/A
    4
    4
    Notes
    [16] - Enrolled Population
    [17] - Enrolled Population
    No statistical analyses for this end point

    Secondary: Number of participants with post-study assessment of lotion qualities (2) using questionnaire

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    End point title
    		 Number of participants with post-study assessment of lotion qualities (2) using questionnaire
    End point description
    Participants from each group completed the post-study questionnaire to rate the qualities of the lotion as compared with other skin emollients used in the past based on their experience. Each participant was asked the following Questions (Q). Q 1: It leaves my skin feeling soft and smooth; Q 2: There is nothing left on my skin; Q 3: Does not feel greasy; Q 4: Disappears into my skin quickly after I put it on; Q 5: Easy to apply; Q 6: Fragrance-free; Q 7: Spreadability; Q 8: Lack of stickiness. Participants rated the qualities of the lotion based on a 5 point scale (5= “Strongly Agree”, 4= “Agree”, 3= “Neutral”, 2= “Disagree", 1= “Strongly Disagree” N/A=Does not apply to me). Participant's rating for each question were summarized.
    End point type
    Secondary
    End point timeframe
    At early withdrawal or end of the therapy visit (up to Week 32)
    End point values
    		 Emollient plus FP 0.05% cream Emollient
    Number of subjects analysed
    54 [18]
    53 [19]
    Units: Participants
        Q 1, 1
    0
    0
        Q 1, 2
    1
    1
        Q 1, 3
    3
    11
        Q 1, 4 or 5
    44
    37
        Q 1, N/A
    0
    1
        Q 2, 1
    0
    0
        Q 2, 2
    3
    4
        Q 2, 3
    1
    8
        Q 2, 4 or 5
    44
    38
        Q 2, N/A
    0
    0
        Q 3, 1
    0
    2
        Q 3, 2
    3
    3
        Q 3, 3
    2
    10
        Q 3, 4 or 5
    43
    35
        Q 3, N/A
    0
    0
        Q 4, 1
    0
    2
        Q 4, 2
    1
    3
        Q 4, 3
    2
    7
        Q 4, 4 or 5
    45
    38
        Q 4, N/A
    0
    0
        Q 5, 1
    0
    2
        Q 5, 2
    1
    1
        Q 5, 3
    2
    5
        Q 5, 4 or 5
    45
    42
        Q 5, N/A
    0
    0
        Q 6, 1
    0
    0
        Q 6, 2
    0
    0
        Q 6, 3
    1
    5
        Q 6, 4 or 5
    47
    45
        Q 6, N/A
    0
    0
        Q 7, 1
    0
    0
        Q 7, 2
    1
    0
        Q 7, 3
    2
    9
        Q 7, 4 or 5
    45
    41
        Q 7, N/A
    0
    0
        Q 8, 1
    0
    2
        Q 8, 2
    3
    3
        Q 8, 3
    2
    10
        Q 8, 4 or 5
    43
    35
        Q 8, N/A
    0
    0
    Notes
    [18] - ITT Population
    [19] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in cutaneous atrophy sign score, epidermal thickening /lichenification sign score and abnormal pigmentation score using Visual Analogue Scale (VAS) at the end of the Acute Phase

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    End point title
    		 Change from Baseline in cutaneous atrophy sign score, epidermal thickening /lichenification sign score and abnormal pigmentation score using Visual Analogue Scale (VAS) at the end of the Acute Phase
    End point description
    Investigator evaluated and scored the signs of cutaneous atrophy (CA), epidermal thickening/lichenification (ET/L) and abnormal pigmentation (AP) using Visual Analogue Scale (ranging from 0 to 10, higher values represent a worse outcome) based on their subjective judgment. The change from Baseline in each signs (Cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation) score at the end of the Acute Phase (Visit 4 [Week 0 or treatment success, depend on which time point comes first) ±2day]) and is calculated as the score at Visit 4 minus the Baseline score. Baseline is defined as the VAS score for each sign obtained before the first dose of study drug in the Acute Phase of the study (Visit 2). Summation of the VAS scores for each sign (CA, ET/L and AP) was done to calculate the Total VAS score (ranging from 0 to 30, higher values represent a worse outcome) at Visit 4 of the Acute Phase of the study.
    End point type
    Secondary
    End point timeframe
    From the start of treatment up to Visit 4 (Week 0) or treatment success (depends on which time point comes first)
    End point values
    		 FP 0.05% cream
    Number of subjects analysed
    123 [20]
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Visit 4, CA
    -0.3 ( 1.12 )
        Visit 4, ET/L
    -1.9 ( 1.57 )
        Visit 4, AP
    -0.7 ( 1.47 )
        Visit 4, Total VAS Score
    -2.9 ( 3.14 )
    Notes
    [20] - Enrolled Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in cutaneous atrophy sign score, epidermal thickening /lichenification sign score and abnormal pigmentation score using Visual Analogue Scale (VAS) at the end of the Maintenance Phase and Follow-up Phase

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    End point title
    		 Change from Baseline in cutaneous atrophy sign score, epidermal thickening /lichenification sign score and abnormal pigmentation score using Visual Analogue Scale (VAS) at the end of the Maintenance Phase and Follow-up Phase
    End point description
    Investigator evaluated and scored the signs of cutaneous atrophy (CA), epidermal thickening/lichenification (ET/L) and abnormal pigmentation (AP) using the Visual Analogue Scale (ranging from 0 to 10, higher values represent a worse outcome) based on their subjective judgment. The change from Baseline in each sign (Cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation) score at the end of the Maintenance Phase and Follow-up Phase and is calculated as the score at the end of the Maintenance and Follow-up Phase minus the Baseline score. Baseline is defined as VAS score for each sign obtained at Visit 4 (end of Acute Phase). Summation of VAS scores for each sign (CA, ET/L and AP) was done to calculate the Total VAS score (ranging from 0 to 30, higher values represent a worse outcome) at the Maintenance and Follow-up phase of study. The missing value was imputed using last-observation-carry-forward (LOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 20 and Week 32
    End point values
    		 Emollient plus FP 0.05% cream Emollient
    Number of subjects analysed
    54 [21]
    53 [22]
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Week 20, CA
    -0.1 ( 0.44 )
    -0.2 ( 1.01 )
        Week 20, ET/L
    -0.4 ( 1.49 )
    0.5 ( 1.51 )
        Week 20, AP
    -0.4 ( 1.42 )
    0.0 ( 1.32 )
        Week 32, CA
    -0.1 ( 0.58 )
    -0.2 ( 1.03 )
        Week 32, ET/L
    0.1 ( 1.19 )
    0.6 ( 1.53 )
        Week 32, AP
    -0.3 ( 1.23 )
    0.0 ( 1.35 )
        Week 20, Total VAS Score
    -0.9 ( 2.61 )
    0.3 ( 2.75 )
        Week 32, Total VAS Score
    -0.3 ( 2.09 )
    0.4 ( 2.82 )
    Notes
    [21] - ITT Population
    [22] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Emollient plus FP 0.05% cream v Emollient
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.701 [23]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
    Notes
    [23] - Week 20, CA
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Emollient plus FP 0.05% cream v Emollient
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0042 [24]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
    Notes
    [24] - Week 20, ET/L
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Emollient plus FP 0.05% cream v Emollient
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.081 [25]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
    Notes
    [25] - Week 20, AP
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Emollient plus FP 0.05% cream v Emollient
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2799 [26]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
    Notes
    [26] - Week 32, CA
    Statistical analysis title
    		 Statistical analysis 5
    Comparison groups
    Emollient plus FP 0.05% cream v Emollient
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1375 [27]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
    Notes
    [27] - Week 32, ET/L
    Statistical analysis title
    		 Statistical analysis 6
    Comparison groups
    Emollient plus FP 0.05% cream v Emollient
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.11 [28]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
    Notes
    [28] - Week 32, AP
    Statistical analysis title
    		 Statistical analysis 7
    Comparison groups
    Emollient plus FP 0.05% cream v Emollient
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0394 [29]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
    Notes
    [29] - Week 20, Total VAS Score
    Statistical analysis title
    		 Statistical analysis 8
    Comparison groups
    Emollient plus FP 0.05% cream v Emollient
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2237 [30]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
         level
    		 95%
    Notes
    [30] - Week 32, Total VAS Score

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32).
    Adverse event reporting additional description
    SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    FP 0.05% cream
    Reporting group description
    		 Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety of FP 0.05% cream was assessed every 2 weeks up to 4 weeks or until treatment success.

    Reporting group title
    Emollient plus FP 0.05% cream
    Reporting group description
    		 Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) less than or equal to 1; and the improvement greater than or equal to 2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.

    Reporting group title
    Emollient
    Reporting group description
    		 Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA less than or equal to 1; and the improvement greater than or equal to 2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.

    Reporting group title
    Follow-up: Emollient
    Reporting group description
    		 Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.

    Serious adverse events
    		 FP 0.05% cream Emollient plus FP 0.05% cream Emollient Follow-up: Emollient
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 116 (0.00%)
    2 / 53 (3.77%)
    0 / 53 (0.00%)
    0 / 66 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mycoplasma infection
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         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
    		 FP 0.05% cream Emollient plus FP 0.05% cream Emollient Follow-up: Emollient
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 116 (3.45%)
    9 / 53 (16.98%)
    9 / 53 (16.98%)
    11 / 66 (16.67%)
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 53 (1.89%)
    1 / 53 (1.89%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    0
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 116 (0.00%)
    4 / 53 (7.55%)
    3 / 53 (5.66%)
    4 / 66 (6.06%)
         occurrences all number
    0
    5
    3
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 53 (0.00%)
    2 / 53 (3.77%)
    1 / 66 (1.52%)
         occurrences all number
    1
    0
    2
    1
    Abdominal distension
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    1
    1
    Abdominal pain
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Retching
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 53 (1.89%)
    3 / 53 (5.66%)
    1 / 66 (1.52%)
         occurrences all number
    0
    1
    3
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 53 (1.89%)
    1 / 53 (1.89%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    1
    1
    Laryngeal pain
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 116 (1.72%)
    3 / 53 (5.66%)
    3 / 53 (5.66%)
    3 / 66 (4.55%)
         occurrences all number
    2
    3
    7
    3
    Tonsillitis
         subjects affected / exposed
    1 / 116 (0.86%)
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 53 (0.00%)
    2 / 53 (3.77%)
    2 / 66 (3.03%)
         occurrences all number
    0
    0
    2
    2
    Exanthema subitum
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    1
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 53 (1.89%)
    0 / 53 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    1
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 53 (0.00%)
    1 / 53 (1.89%)
    0 / 66 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Laryngitis
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    0
    2

    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
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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