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    Clinical Trial Results:
    Proactive Treatment With [0.03%] Tacrolimus Ointment in Children With Moderate/Severe Atopic Dermatitis: A Randomized, Multicenter, Open-label Study.

    Summary
    EudraCT number
    		 2015-001040-11
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    30 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Feb 2016
    First version publication date
    18 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ACN-PRT-AD-12-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01745159
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Astellas Pharma (China) Co., Ltd
    Sponsor organisation address
    No. 8 Jianguomenwai Avenue, Chaoyang District, Beijing , China,
    Public contact
    Clinical Trial Disclosure , Astellas Pharma (China), Astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Trial Disclosure , Astellas Pharma (China), Astellas.resultsdisclosure@astellas.com
    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
    30 Nov 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Nov 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Main objective of the trial was to assess if proactive, 2 times-weekly application of 0.03% tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.
    Protection of trial subjects
    This study complies with the Helsinki ethics guidelines for human medical research and was executed in accordance with the China Food and Drug Administration’s (CFDA) GCP ethical requirements and applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 Atopic dermatitis (AD) is a hereditary immunologic abnormality associated with chronic, inflammatory, recurring skin disease characterized by intense pruritus and dry skin. Recent research has shown that normal skin in atopic dermatitis (AD) patients contains subclinical inflammation, so continued anti-inflammatory therapy is necessary to prevent disease exacerbation. Tacrolimus ointment (brand name: Protopic®) is a macrolide calcineurin inhibitor, and several studies have demonstrated efficacy in treating AD. Several long-term studies have confirmed that intermittent maintenance therapy with tacrolimus twice weekly can decrease the number of disease exacerbations and prolong the interval between exacerbations.
    Actual start date of recruitment
    13 Sep 2012
    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: 171
    Worldwide total number of subjects
    171
    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)
    0
    Children (2-11 years)
    160
    Adolescents (12-17 years)
    11
    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
    		 Males and females, ages 2 to 15 years with moderate to severe atopic dermatitis (AD).

    Pre-assignment
    Screening details
    		 At the start of period 1, 171 patients were screened and approved to enter the study.All patients received 0.03% topical tacrolimus ointment twice daily for 2-6 weeks.At the end of period 1, 125 patients completed treatment and had (investigator general assessment) IGA ≤2.They were randomized in period 2, out of 125 patients 121 completed the study

    Period 1
    Period 1 title
    Tacrolimus 0.03% [Twice Daily]
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Tacrolimus ointment 0.03%
    Arm description
    		 All moderate to severe atopic dermatitis patients who met eligibility criteria received conventional therapy of 0.03% Tacrolimus ointment twice daily for up to 6 weeks. At the end of period 1, those who achieved IGA ≤2 were entered into Period 2 and randomized 1:1 into the experimental group or control arm for the efficacy and safety observation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tacrolimus ointment 0.03%
    Investigational medicinal product code
    Other name
    Protopic
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    All patients applied 0.03% tacrolimus ointment to affected areas topically twice daily for up to 6 weeks. Thin layer of tacrolimus ointment was used to cover skin lesion by gentle daubing. The area applied with ointment should not have been bandaged. Patients were asked not to take the shower soon after the application, and no skin washing instruction was provided prior to application. Tacrolimus ointment was provided in tubes of 10 grams.

    Number of subjects in period 1
    		Tacrolimus ointment 0.03%
    Started
    171
    Completed
    125
    Not completed
    46
         Consent withdrawn by subject
    1
         Treatment termination as per investigator advice
    3
         Other
    12
         Serious protocol deviation as per investigator
    2
         Lost to follow-up
    8
         '[IGA > 2] Period 1 - after 6 weeks of treatment '
    20
    Period 2
    Period 2 title
    Tacrolimus 0.03% [Twice Weekly]v Control
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tacrolimus 0.03% [Twice a week-Mon & Thu]
    Arm description
    		 In the experimental group in period 2 tacrolimus ointment 0.03% was applied topically twice a week on Mondays and Thursdays. If disease exacerbation occurred patients were switched to conventional therapy and were followed-up for 6 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tacrolimus 0.03% [Twice a Week]
    Investigational medicinal product code
    Other name
    Protopic
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    All patients applied 0.03% tacrolimus ointment to affected areas topically twice weekly on Monday and Thursday for up to 6 weeks. Thin layer of tacrolimus ointment was used to cover the skin lesion by gentle daubing. The applied area was free of any bandages. Patients were asked not to take the shower soon after the application, and no instruction was provided for skin washing prior to application. Tacrolimus ointment was provided in tubes of 10 grams.

    Arm title
    		 Control Group
    Arm description
    		 In the control group no treatment was administered in period 2 unless there was disease exacerbation. Patients who experienced disease exacerbation received conventional treatment and were followed-up for a period of 6 months.
    Arm type
    		 Control Group

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Tacrolimus 0.03% [Twice a week-Mon & Thu] Control Group
    Started
    62
    63
    Completed
    45
    47
    Not completed
    17
    16
         Treatment termination as per investigator advice
    1
    1
         IGA≤2 Period 1 end&re-occurance of IGA>2 in 7 Days
    -
    1
         IGA>2 after 6 weeks of treatment with Tacrolimus
    5
    3
         Other
    5
    8
         Lost to follow-up
    6
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tacrolimus 0.03% [Twice Daily]
    Reporting group description
    		 -

    Reporting group values
    		 Tacrolimus 0.03% [Twice Daily] Total
    Number of subjects
    		 171 171
    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)
    		 160 160
        Adolescents (12-17 years)
    		 11 11
        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)
    		 6.61 ( 3.05 ) -
    Gender categorical
    Units: Subjects
        Female
    		 78 78
        Male
    		 93 93
    Ethnicity
    Units: Subjects
        Han Chinese
    		 164 164
        Other
    		 7 7
    Height
    Units: centimeters
        arithmetic mean (standard deviation)
    		 121.54 ( 21.91 ) -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 26.2 ( 11.22 ) -
    BMI
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 17.21 ( 3.45 ) -

    End points

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    End points reporting groups
    Reporting group title
    Tacrolimus ointment 0.03%
    Reporting group description
    		 All moderate to severe atopic dermatitis patients who met eligibility criteria received conventional therapy of 0.03% Tacrolimus ointment twice daily for up to 6 weeks. At the end of period 1, those who achieved IGA ≤2 were entered into Period 2 and randomized 1:1 into the experimental group or control arm for the efficacy and safety observation.
    Reporting group title
    Tacrolimus 0.03% [Twice a week-Mon & Thu]
    Reporting group description
    		 In the experimental group in period 2 tacrolimus ointment 0.03% was applied topically twice a week on Mondays and Thursdays. If disease exacerbation occurred patients were switched to conventional therapy and were followed-up for 6 months.

    Reporting group title
    Control Group
    Reporting group description
    		 In the control group no treatment was administered in period 2 unless there was disease exacerbation. Patients who experienced disease exacerbation received conventional treatment and were followed-up for a period of 6 months.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) included patients who have received randomized assignment, at least 1 dose of study medication, and at least 1 efficacy assessment. The FAS was used as the major set for efficacy analysis of this study.

    Subject analysis set title
    Safety Analysis Set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAF included patients who have received randomized assignment, at least 1 dose of study medication, and at least 1 safety assessment. The SAF was used as the major set for safety analysis of this study.

    Subject analysis set title
    Per Protocol Set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Set (PPS) is a FAS subset and includes patients from FAS who have no serious protocol deviation, and who are compliant (the actual dosage used is 80%-120% of the planned dosage) and do not have missing data of primary efficacy measures. In this study, PPS was used as the secondary population for efficacy analysis, since patients who withdraw due to a lack of response were also included. Number of patients were censored, from the time to first disease exacerbation, and analyzed with the survival analysis. Time to first disease exacerbation, and the outcome was either (first) disease exacerbation or censored (or deleted) data. The time to first disease exacerbation was defined as the number of days between the end of treatment in stage 1 and the time to first disease exacerbation (i.e. the time to first disease exacerbation [days] = the date of first disease exacerbation - the date of the end of treatment).

    Primary: Time to first disease exacerbation (FAS)

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    End point title
    		 Time to first disease exacerbation (FAS)
    End point description
    Disease exacerbation was defined as IGA>2. The time to first disease exacerbation was the number of days between the end of treatment in stage 1 and the time to first disease exacerbation, i.e. the time to first disease exacerbation (days) = the date of first disease exacerbation - the date of the end of treatment in stage 1+1. The number of censored cases in time to first disease exacerbation was 35 for the Tacrolimus arm and 15 for the Control arm in the Full Analysis Set.
    End point type
    Primary
    End point timeframe
    Week 2 - Month 6 [+(-) 7days]
    End point values
    		 Tacrolimus 0.03% [Twice a week-Mon & Thu] Control Group
    Number of subjects analysed
    25
    46
    Units: Number
        arithmetic mean (standard deviation)
    46.88 ( 37.71 )
    28.83 ( 32.33 )
    Statistical analysis title
    		 Cox regression analysis / Group
    Statistical analysis description
    Cox Regression Analysis includes patients with disease exacerbation as well as the censored patients. Total number of patients who have entered period 2 was 121, this was a number of patients that was subject to survival analysis.
    Comparison groups
    Tacrolimus 0.03% [Twice a week-Mon & Thu] v Control Group
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.0001
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.214
         upper limit
    		 0.573
    Notes
    [1] - A Cox regression model was adopted using the stepwise regression method to incorporate factors such as group, gender, age, disease severity, EASI score, VAS score, and IGA score upon entry into stage 2, and the overall response to the treatment in stage 1 into the regression model.
    Statistical analysis title
    		 Cox regression analysis / Gender [Male & Female]
    Statistical analysis description
    Cox Regression Analysis includes patients with disease exacerbation as well as the censored patients. Total number of patients who have entered period 2 was 121, this was a number of patients that was subject to survival analysis. Furthermore this statitcial analysis compares Females to Males.
    Comparison groups
    Tacrolimus 0.03% [Twice a week-Mon & Thu] v Control Group
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.0329
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.665
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.042
         upper limit
    		 2.66
    Notes
    [2] - A Cox regression model was adopted using the stepwise regression method to incorporate factors such as group, gender, age, disease severity, EASI score, VAS score, and IGA score upon entry into stage 2, and the overall response to the treatment in stage 1 into the regression model.
    Statistical analysis title
    		 The time to first disease exacerbation
    Comparison groups
    Tacrolimus 0.03% [Twice a week-Mon & Thu] v Control Group
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.02
    Method
    		 Rank Sum Test
    Confidence interval
    Statistical analysis title
    		 Time to first disease exacerbation [Log Rank]
    Statistical analysis description
    Total number of patients used for this analysis was 121.
    Comparison groups
    Tacrolimus 0.03% [Twice a week-Mon & Thu] v Control Group
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Confidence interval

    Secondary: The number of disease exacerbations in period 2 (FAS)

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    End point title
    		 The number of disease exacerbations in period 2 (FAS)
    End point description
    Exacerbation is documented if the inter-exacerbation interval is < 7 days. Only patients with disease exacerbation were analyzed. Patients with no disease exacerbation were excluded from the analysis. The number of patient-time disease exacerbations in stage 2 = the total number of disease exacerbations in stage 2 or the total observation time (patient-months) in stage 2.
    End point type
    Secondary
    End point timeframe
    Week 2 to Month 6 [+(-) 7 days]
    End point values
    		 Tacrolimus 0.03% [Twice a week-Mon & Thu] Control Group
    Number of subjects analysed
    60
    61
    Units: Number
        arithmetic mean (standard deviation)
    0.52 ( 0.68 )
    1.41 ( 1.23 )
    Statistical analysis title
    		 Number of disease exacerbations Stage 2 (FAS)
    Comparison groups
    Tacrolimus 0.03% [Twice a week-Mon & Thu] v Control Group
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Group T-test
    Confidence interval

    Secondary: The disease severity EASI score at disease exacerbation in period 2 (FAS)

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    End point title
    		 The disease severity EASI score at disease exacerbation in period 2 (FAS)
    End point description
    EASI is an overall score calculated based on the severity and the area of skin lesions at each section, as well as age group (≥8 and <8 years of age) and the area of each section as a percentage of the total body surface area. It is calculated as follows: 1) Clinical symptom evaluation which can be divided into 4 categories: erythema, papules/swelling, scratches/epidermal excoriations, lichenification. Each clinical manifestation has a severity score on a scale of 0-3. 0 = none, 1 = mild, 2 = moderate, 3 = severe. 2) Clinical surface area involvement score: ① Body is divided into 4 areas: head/neck (H), upper limb (UL), trunk (T), lower limb (LL). Upper limb includes outer armpit and hands. ② In calculating the size of skin area covered by lesions, the patient’s palm is taken as an approximation of 1% of the body. 3) The proportion of skin surface area occupied by lesions in each location is assigned a number on a scale of 0-6.
    End point type
    Secondary
    End point timeframe
    Week 2 to Month 6 (+(-) 7 Days)
    End point values
    		 Tacrolimus 0.03% [Twice a week-Mon & Thu] Control Group
    Number of subjects analysed
    25
    46
    Units: Number on a Scale
        arithmetic mean (standard deviation)
    10.88 ( 9.42 )
    9.72 ( 10.43 )
    Statistical analysis title
    		 EASI score disease exacerbation stage 2 (FAS)
    Comparison groups
    Tacrolimus 0.03% [Twice a week-Mon & Thu] v Control Group
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3927
    Method
    		 Rank Sum Test
    Confidence interval

    Secondary: The IGA (Investigator General Assessment) score at disease exacerbation in period 2 (FAS)

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    End point title
    		 The IGA (Investigator General Assessment) score at disease exacerbation in period 2 (FAS)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 2- Month 6 (+(-) 7 Days)
    End point values
    		 Tacrolimus 0.03% [Twice a week-Mon & Thu] Control Group
    Number of subjects analysed
    25
    46
    Units: Number
        arithmetic mean (standard deviation)
    3.16 ( 0.37 )
    3.22 ( 0.51 )
    Statistical analysis title
    		 IGA score at 1st disease exacerbation Stage 2(FAS)
    Statistical analysis description
    The investigator general assessment (IGA) score at the first disease exacerbation in stage 2 for inter-group comparison (FAS).
    Comparison groups
    Tacrolimus 0.03% [Twice a week-Mon & Thu] v Control Group
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8315
    Method
    		 Rank Sum Test
    Confidence interval

    Secondary: The duration of disease exacerbation in period 2 (FAS)

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    End point title
    		 The duration of disease exacerbation in period 2 (FAS)
    End point description
    The duration of the first disease exacerbation (days) = (the end date of the first disease exacerbation – the start date of the first disease exacerbation +1). In case of multiple disease exacerbations in stage 2, the duration of each disease exacerbation is added. In case of disease exacerbation at the end of observation period, then the end date of disease exacerbation at the end of the observation period is used for calculation.
    End point type
    Secondary
    End point timeframe
    Week 2 - Month 6 (+(-) 7 Days)
    End point values
    		 Tacrolimus 0.03% [Twice a week-Mon & Thu] Control Group
    Number of subjects analysed
    25
    46
    Units: Number
        arithmetic mean (standard deviation)
    33.64 ( 26.32 )
    48.76 ( 30.79 )
    Statistical analysis title
    		 Disease exacerbation stage 2 intergroup (FAS)
    Comparison groups
    Tacrolimus 0.03% [Twice a week-Mon & Thu] v Control Group
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0662
    Method
    		 Rank Sum Test
    Confidence interval

    Secondary: The itching score at disease exacerbation in period 2 (FAS)

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    End point title
    		 The itching score at disease exacerbation in period 2 (FAS)
    End point description
    Patients score their itching on a 10 cm visual analogue scale (VAS). The post-treatment and pre-treatment scores are compared. If the difference follows a normal distribution, a paired t test is performed; if the difference does not follow a normal distribution, a Wilcoxon signed-rank test is performed.
    End point type
    Secondary
    End point timeframe
    Week 2- Months 6 (+(-) 7 days)
    End point values
    		 Tacrolimus 0.03% [Twice a week-Mon & Thu] Control Group
    Number of subjects analysed
    25
    46
    Units: Number
        arithmetic mean (standard deviation)
    5.84 ( 1.53 )
    5.66 ( 1.96 )
    Statistical analysis title
    		 The itching (VAS) score Period 2 (FAS)
    Comparison groups
    Tacrolimus 0.03% [Twice a week-Mon & Thu] v Control Group
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9469
    Method
    		 Rank Sum Test
    Confidence interval

    Secondary: The overall dosage of tacrolimus in period 2 (FAS)

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    End point title
    		 The overall dosage of tacrolimus in period 2 (FAS)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 2- Month 6 (+(-) 7days)
    End point values
    		 Tacrolimus 0.03% [Twice a week-Mon & Thu] Control Group
    Number of subjects analysed
    60
    61
    Units: Number
        arithmetic mean (standard deviation)
    8 ( 6.98 )
    4.2 ( 6.88 )
    Statistical analysis title
    		 The overall dosage of tacrolimus in period 2 (FAS)
    Comparison groups
    Tacrolimus 0.03% [Twice a week-Mon & Thu] v Control Group
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0031
    Method
    		 Paired t-test
    Confidence interval

    Secondary: The overall response rate in period 1 (FAS)

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    End point title
    		 The overall response rate in period 1 (FAS)
    End point description
    The overall response rate is the sum of the cure rate and effective rate. period 1 overall rate of improvement (%)=(pre-treatment EASI - post-treatment EASI)/pre-treatment EASI×100.00; pre-treatment refers to the screening period (day 0), post-treatment refers to the period 1 end time; post-treatment EASI assessment information was not obtained for 5 patients The overall improvement is rated according to a 4-point efficacy scale: cure: overall improvement ≥90%; effective: 60%-<90%; improved: 20%-<60%; ineffective: <20%.
    End point type
    Secondary
    End point timeframe
    Week 2- 6 Months (+(-) 7 days)
    End point values
    		 Tacrolimus ointment 0.03%
    Number of subjects analysed
    166
    Units: Number
        arithmetic mean (standard deviation)
    69.04 ( 37.22 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were recorded from the start of the study up until the End of Treatment. In case of disease exacerbation particpiants were followed up to 6 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Period 2 - Control Group
    Reporting group description
    		 -

    Reporting group title
    Period 2 - 0.03% Tacrolimus [2 times a week]
    Reporting group description
    		 -

    Serious adverse events
    		 Period 2 - Control Group Period 2 - 0.03% Tacrolimus [2 times a week]
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Period 2 - Control Group Period 2 - 0.03% Tacrolimus [2 times a week]
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 61 (26.23%)
    16 / 60 (26.67%)
    Respiratory, thoracic and mediastinal disorders
    Nasopharyngitis
         subjects affected / exposed
    4 / 61 (6.56%)
    1 / 60 (1.67%)
         occurrences all number
    4
    1
    Upper respiratory tract
         subjects affected / exposed
    5 / 61 (8.20%)
    1 / 60 (1.67%)
         occurrences all number
    6
    1
    Skin and subcutaneous tissue disorders
    Impetigo
         subjects affected / exposed
    2 / 61 (3.28%)
    4 / 60 (6.67%)
         occurrences all number
    2
    4

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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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