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    Clinical Trial Results:
    Childhood atopic dermatitis : allergic sensitisation, long-term treatment, and genetics

    Summary
    EudraCT number
    		 2012-002412-95
    Trial protocol
    		 FI  
    Global end of trial date
    18 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jan 2025
    First version publication date
    25 Jan 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Atopia
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Miia Perälä, HUS, Skin and allergy Hospital
    Sponsor organisation address
    PL 160, Helsinki, Finland, 00029
    Public contact
    Anita Remitz, Iho-ja allergiasairaala/SKin and Allergy Hospital, 358 9471 86355, anita.remitz@hus.fi
    Scientific contact
    Anita Remitz, Iho-ja allergiasairaala, 358 9471 86355, anita.remitz@hus.fi
    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 Jun 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Jun 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Long-term treatment of moderate-to severe childhood atopic eczema with two different treatment regimens.
    Protection of trial subjects
    Informend concents from caregivers, right to withdraw fro the study at any time point with no implications. Study plan approved of national ethics committee. Right to contact study nurse/investigator at any time point. Previously studied treatment (ointments) used.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 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
    Finland: 152
    Worldwide total number of subjects
    152
    EEA total number of subjects
    152
    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)
    152
    Children (2-11 years)
    0
    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
    		 1-3 year-old children with moderate-to-severe atopic eczema.

    Pre-assignment
    Screening details
    		 Moderate-to severe atopic eczema based on Rajka-Langeland criteria. 2 weeks wash-out perriod before baseline 152 patients enrolled

    Pre-assignment period milestones
    Number of subjects started
    		 152
    Number of subjects completed
    		 152

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TAC-group
    Arm description
    		 Treatment with tacrolimus
    Arm type
    		 Experimental

    Investigational medicinal product name
    Protopic 0,03%
    Investigational medicinal product code
    Other name
    Tacrolimus
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Treatment was twice daily until clearance was achieved, after which it continued as twice-weekly maintenance therapy.

    Investigational medicinal product name
    Protopic 0,1%
    Investigational medicinal product code
    Other name
    Tacrolimus
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use
    Dosage and administration details
    treatment was twice daily until clearance was achieved, after which it continued as twice-weekly maintenance therapy.

    Arm title
    		 TCS-group
    Arm description
    		 Treatment with corticosteroids
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hydrocortison 1%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Twice daily for 3-7 days, followed by a treatment pause lasting a minimum of 3-7 days. Treatment was restarted in case of a flare-up based on parents’ or caregiver’s decision.

    Investigational medicinal product name
    Bucort 0,1%
    Investigational medicinal product code
    Other name
    Hydrocortison-17-butyrate
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    In case of Hyrcostison was inneffective, twice daily for 3-7 days, followed by a treatment pause lasting a minimum of 3-7 days. Treatment was restarted in case of a flare-up based on parents’ or caregiver’s decision.

    Number of subjects in period 1
    		TAC-group TCS-group
    Started
    77
    75
    Completed
    77
    75
    Period 2
    Period 2 title
    Overall trial
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TCS-group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hydrocortison 1%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Twice daily for 3-7 days, followed by a treatment pause lasting a minimum of 3-7 days. Treatment was restarted in case of a flare-up based on parents’ or caregiver’s decision.

    Investigational medicinal product name
    Bucort 0,1%
    Investigational medicinal product code
    Other name
    Hydrocortison-17-butyrate
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    In case of Hyrcostison was inneffective, twice daily for 3-7 days, followed by a treatment pause lasting a minimum of 3-7 days. Treatment was restarted in case of a flare-up based on parents’ or caregiver’s decision.

    Arm title
    		 TAC-group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Protopic 0,03%
    Investigational medicinal product code
    Other name
    Tacrolimus
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Treatment was twice daily until clearance was achieved, after which it continued as twice-weekly maintenance therapy.

    Investigational medicinal product name
    Protopic 0,1%
    Investigational medicinal product code
    Other name
    Tacrolimus
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use
    Dosage and administration details
    treatment was twice daily until clearance was achieved, after which it continued as twice-weekly maintenance therapy.

    Number of subjects in period 2
    		TCS-group TAC-group
    Started
    75
    77
    Completed
    62
    60
    Not completed
    13
    17
         Consent withdrawn by subject
    -
    3
         Moving away
    1
    2
         Lost to follow-up
    4
    4
         Lack of efficacy
    5
    6
         Protocol deviation
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TAC-group
    Reporting group description
    		 Treatment with tacrolimus

    Reporting group title
    TCS-group
    Reporting group description
    		 Treatment with corticosteroids

    Reporting group values
    		 TAC-group TCS-group Total
    Number of subjects
    		 77 75 152
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 0
    Age continuous
    Age at baseline
    Units: years
        arithmetic mean (standard deviation)
    		 1.8 ( 0.7 ) 1.8 ( 0.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 42 31 73
        Male
    		 35 44 79
    BSA %
    Eczema area
    Units: 0-100 %
        arithmetic mean (standard deviation)
    		 29.4 ( 24.8 ) 25.7 ( 30.0 ) -
    EASI
    Eczema severity assesment
    Units: 0-72
        arithmetic mean (standard deviation)
    		 13.3 ( 10.3 ) 11.4 ( 7.7 ) -

    End points

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    End points reporting groups
    Reporting group title
    TAC-group
    Reporting group description
    		 Treatment with tacrolimus

    Reporting group title
    TCS-group
    Reporting group description
    		 Treatment with corticosteroids
    Reporting group title
    TCS-group
    Reporting group description
    		 -

    Reporting group title
    TAC-group
    Reporting group description
    		 -

    Primary: EASI_36 months

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    End point title
    		 EASI_36 months
    End point description
    End point type
    Primary
    End point timeframe
    36 months
    End point values
    		 TAC-group TCS-group
    Number of subjects analysed
    57
    57
    Units: 0-72
    57
    57
    Statistical analysis title
    		 EASI_36
    Statistical analysis description
    Difference in eczema severity between the treatment groups at 36 months
    Comparison groups
    TAC-group v TCS-group
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 1.8
    Variability estimate
    Standard deviation
    Dispersion value
    1.3
    Notes
    [1] - mean fifference

    Primary: BSA_36 months

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    End point title
    		 BSA_36 months
    End point description
    End point type
    Primary
    End point timeframe
    36 months
    End point values
    		 TAC-group TCS-group
    Number of subjects analysed
    60
    60
    Units: %
    60
    60
    Statistical analysis title
    		 EASI_36
    Statistical analysis description
    Eczema severity difference at 36 months between treatment groups
    Comparison groups
    TCS-group v TAC-group
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 1.8
    Variability estimate
    Standard deviation
    Dispersion value
    1.3
    Statistical analysis title
    		 BSA_36
    Statistical analysis description
    Eczema area difference (%) at 36 months
    Comparison groups
    TAC-group v TCS-group
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 4.2
    Variability estimate
    Standard deviation
    Dispersion value
    0.7

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to 36 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    TAC-group
    Reporting group description
    		 tac-treated patients

    Reporting group title
    TCS-group
    Reporting group description
    		 Corticosteroid-treated patients

    Serious adverse events
    		 TAC-group TCS-group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 75 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 4.6%
    Non-serious adverse events
    		 TAC-group TCS-group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 77 (9.09%)
    1 / 75 (1.33%)
    Skin and subcutaneous tissue disorders
    Burning sensation
         subjects affected / exposed
    7 / 77 (9.09%)
    0 / 75 (0.00%)
         occurrences all number
    7
    0
    Endocrine disorders
    Cortisol decreased
    Additional description: S-cortisol was decreased, but follwing ACTH test was normal.
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1

    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.
    The restricted cohort size can be seen as a limitation. The cohort size was due to the study being a single-centre investigator-initiated clinical study with young infants and relatively frequent follow-up visits.
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    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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