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    Clinical Trial Results:
    An open label, 52 week, multicenter study, of long term management to evaluate effectiveness, tolerability and safety of pimecrolimus cream 1%, Elidel® in pediatric patients with mild to moderate atopic dermatitis in a daily practice

    Summary
    EudraCT number
    		 2017-001766-25
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Sep 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Mar 2018
    First version publication date
    25 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CASM981CVE01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00509990
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    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
    18 Sep 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Sep 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the use of corticosteroid from day 1 to week 52 in patients using Elidel® cream 1% for the long term management in mild to moderate atopic dermatitis (AD) in pediatric patients in a daily practice.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Apr 2005
    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
    Mexico: 90
    Country: Number of subjects enrolled
    Venezuela, Bolivarian Republic of: 89
    Worldwide total number of subjects
    179
    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)
    62
    Children (2-11 years)
    117
    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
    		 -

    Pre-assignment
    Screening details
    		 A total of 179 children between 3 months and 12 year old, from a total of 10 centers located in Mexico and Venezuela, were enrolled.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Pimecrolimus cream 1 %
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pimecrolimus cream 1 %
    Investigational medicinal product code
    Other name
    Elidel
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Elidel® b.i.d. on “as needed” basis to all affected areas.

    Number of subjects in period 1
    		Pimecrolimus cream 1 %
    Started
    179
    Completed
    157
    Not completed
    22
         Consent withdrawn by subject
    7
         Protocol violation
    1
         Unsatisfactory therapeutic effect
    1
         Lost to follow-up
    12
         Enrollment failure
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Period
    Reporting group description
    		 -

    Reporting group values
    		 Overall Period Total
    Number of subjects
    		 179 179
    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)
    		 62 62
        Children (2-11 years)
    		 117 117
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 4.13 ± 3.28 -
    Gender categorical
    Units: Subjects
        Female
    		 96 96
        Male
    		 83 83

    End points

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    End points reporting groups
    Reporting group title
    Pimecrolimus cream 1 %
    Reporting group description
    		 -

    Primary: Total and relative number of patients distribution based on Corticosteroid use

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    End point title
    		 Total and relative number of patients distribution based on Corticosteroid use [1]
    End point description
    Corticosteroids use by patients during the course of the study.
    End point type
    Primary
    End point timeframe
    up to week 52
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been reported for this primary end point.
    End point values
    		 Pimecrolimus cream 1 %
    Number of subjects analysed
    130 [2]
    Units: patients
    number (not applicable)
        No
    84
        Yes
    46
    Notes
    [2] - Primary Endpoint population (per protocol)
    No statistical analyses for this end point

    Primary: Total and relative number of patients based on number of disease flares that required Corticosteroids treatment

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    End point title
    		 Total and relative number of patients based on number of disease flares that required Corticosteroids treatment [3]
    End point description
    End point type
    Primary
    End point timeframe
    up to week 52
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been reported for this primary end point.
    End point values
    		 Pimecrolimus cream 1 %
    Number of subjects analysed
    130 [4]
    Units: patients
    number (not applicable)
        01
    23
        02
    10
        03
    2
        04
    3
        05
    2
        More than 5
    3
        Total
    46
    Notes
    [4] - Primary Endpoint population (per protocol)
    No statistical analyses for this end point

    Primary: Duration of use of corticosteroids (non-continuous), within those patients that did use corticosteroids

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    End point title
    		 Duration of use of corticosteroids (non-continuous), within those patients that did use corticosteroids [5]
    End point description
    The average number of days Corticosteroids were used in the 52 week observation period.
    End point type
    Primary
    End point timeframe
    up to week 52
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been reported for this primary end point.
    End point values
    		 Pimecrolimus cream 1 %
    Number of subjects analysed
    179 [6]
    Units: days
    number (not applicable)
        Less than a week
    15
        1-2 weeks
    12
        2-4 weeks
    12
        More than a month
    7
        Total
    46
    Notes
    [6] - Primary Endpoint population (per protocol)
    No statistical analyses for this end point

    Secondary: Relative Patient distribution based on Investigator Global Assessment (IGA) per Visit

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    End point title
    		 Relative Patient distribution based on Investigator Global Assessment (IGA) per Visit
    End point description
    The evaluation of IGA indicates that the percentage of patients “without disease” and “almost without disease”.
    End point type
    Secondary
    End point timeframe
    up to week 52
    End point values
    		 Pimecrolimus cream 1 %
    Number of subjects analysed
    179 [7]
    Units: percent
    number (not applicable)
        Visit 1 - No disease - Almost no disease
    17.9
        Visit 1 - Mild disease - Severe Disease
    82.1
        Visit 1 - Unknown
    0
        Visit 1 - Total
    100
        Visit 1 - Base
    179
        Visit 2 - No disease - Almost no disease
    69.5
        Visit 2 - Mild disease - Severe Disease
    29.9
        Visit 2 - Unknown
    0.6
        Visit 2 - Total
    100
        Visit 2 - Base
    174
        Visit 3 - No disease - Almost no disease
    78.8
        Visit 3 - Mild disease - Severe Disease
    21.12
        Visit 3 - Unknown
    0
        Visit 3 - Total
    100
        Visit 3 - Base
    170
        Visit 4 - No disease - Almost no disease
    82.9
        Visit 4 - Mild disease - Severe Disease
    16.5
        Visit 4 - Unknown
    0.6
        Visit 4 - Total
    100
        Visit 4 - Base
    164
        Visit 5 - No disease - Almost no disease
    78.6
        Visit 5 - Mild disease - Severe Disease
    21.4
        Visit 5 - Unknown
    0
        Visit 5 - Total
    100
        Visit 5 - Base
    159
        Visit 6 - No disease - Almost no disease
    80.9
        Visit 6 - Mild disease - Severe Disease
    19.1
        Visit 6 - Unknown
    0
        Visit 6 - Total
    100
        Visit 6 - Base
    157
    Notes
    [7] - per protocol population
    No statistical analyses for this end point

    Secondary: Relative Patient distribution based on Investigator Facial Global Assessment per Visit

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    End point title
    		 Relative Patient distribution based on Investigator Facial Global Assessment per Visit
    End point description
    End point type
    Secondary
    End point timeframe
    up to week 52
    End point values
    		 Pimecrolimus cream 1 %
    Number of subjects analysed
    179 [8]
    Units: percent
    number (not applicable)
        Visit 1 - No disease - Almost no disease
    63.1
        Visit 1 - Mild disease - Severe Disease
    3639
        Visit 1 - Unknown
    0
        Visit 1 - Total
    100
        Visit 1 - Base
    179
        Visit 2 - No disease - Almost no disease
    90.8
        Visit 2 - Mild disease - Severe Disease
    8.6
        Visit 2 - Unknown
    0.6
        Visit 2 - Total
    100
        Visit 2 - Base
    174
        Visit 3 - No disease - Almost no disease
    95.3
        Visit 3 - Mild disease - Severe Disease
    4.7
        Visit 3 - Unknown
    0
        Visit 3 - Total
    100
        Visit 3 - Base
    170
        Visit 4 - No disease - Almost no disease
    93.9
        Visit 4 - Mild disease - Severe Disease
    6.1
        Visit 4 - Unknown
    0.6
        Visit 4 - Total
    100
        Visit 4 - Base
    164
        Visit 5 - No disease - Almost no disease
    93.1
        Visit 5 - Mild disease - Severe Disease
    6.3
        Visit 5 - Unknown
    0.6
        Visit 5 - Total
    100
        Visit 5 - Base
    159
        Visit 6 - No disease - Almost no disease
    96.2
        Visit 6 - Mild disease - Severe Disease
    3.8
        Visit 6 - Unknown
    0
        Visit 6 - Total
    100
        Visit 6 - Base
    157
    Notes
    [8] - per protocol population
    No statistical analyses for this end point

    Secondary: Average Scores for Parent Index Quality of Life questionnare per Visit

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    End point title
    		 Average Scores for Parent Index Quality of Life questionnare per Visit
    End point description
    End point type
    Secondary
    End point timeframe
    up to week 52
    End point values
    		 Pimecrolimus cream 1 %
    Number of subjects analysed
    179 [9]
    Units: scores on a scale
    number (not applicable)
        Visit 1
    12.32
        Visit 4
    8.82
        Visit 6
    7.22
    Notes
    [9] - per protocol population n = 148, 156, 140
    No statistical analyses for this end point

    Secondary: Average Scores for Child Index Quality of Life questionnaire per Visit

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    End point title
    		 Average Scores for Child Index Quality of Life questionnaire per Visit
    End point description
    End point type
    Secondary
    End point timeframe
    up to week 52
    End point values
    		 Pimecrolimus cream 1 %
    Number of subjects analysed
    179 [10]
    Units: scores on a scale
    number (not applicable)
        Visit 1
    7.9
        Visit 2
    4.4
        Visit 3
    3.9
        Visit 4
    2.7
        Visit 5
    2.4
        Visit 6
    2.2
    Notes
    [10] - per protocol population n= 53, 54, 59, 62, 52, 53
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Unspecified
    Dictionary version
    unk
    Reporting groups
    Reporting group title
    Pimecrolimus cream 1 %
    Reporting group description
    		 -

    Serious adverse events
    		 Pimecrolimus cream 1 %
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 179 (1.68%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Diarrhea and gastroenteritis of presumed infectious origin
         subjects affected / exposed
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cellulitis, unspecified
         subjects affected / exposed
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia, unspecified
         subjects affected / exposed
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pimecrolimus cream 1 %
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    135 / 179 (75.42%)
    Gastrointestinal disorders
    Diarrhoea infectious
         subjects affected / exposed
    44 / 179 (24.58%)
         occurrences all number
    44
    Respiratory, thoracic and mediastinal disorders
    Acute Upper Respiratory Tract Infection
         subjects affected / exposed
    134 / 179 (74.86%)
         occurrences all number
    134
    Allergic Rhinitis
         subjects affected / exposed
    71 / 179 (39.66%)
         occurrences all number
    71
    Cough
         subjects affected / exposed
    59 / 179 (32.96%)
         occurrences all number
    59

    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
    For support, Contact us.
    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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