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    Clinical Trial Results:
    The effects of topical corticosteroid use on insulin sensitivity and bone turnover

    Summary
    EudraCT number
    		 2018-004370-96
    Trial protocol
    		 DK  
    Global end of trial date
    15 Mar 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    10 Apr 2023
    First version publication date
    27 Apr 2022
    Other versions
    		 v1
    Version creation reason
    • Changes to summary attachments
    Link to published open access paper: https://onlinelibrary.wiley.com/doi/10.1111/all.15690

    Trial information

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    Trial identification
    Sponsor protocol code
    LG-TCS-AD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04114097
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gentofte Hospital
    Sponsor organisation address
    Gentofte Hospitalsvej 15, 1. sal, Hellerup, Denmark, 2900
    Public contact
    Department of Dermatology, Gentofte Hospital, lise.gether.01@regionh.dk
    Scientific contact
    Department of Dermatology, Gentofte Hospital, lise.gether.01@regionh.dk
    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
    Interim
    Date of interim/final analysis
    15 Mar 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We hypothesise that use of TCS elicits insulin resistance and increases bone resorption (indicating increased risk of osteoporosis) in AD patients. The aim is, therefore, to explore the adverse systemic drug reactions of TCS. Specifically, we aim to 1. evaluate whether full-body TCS treatment results in hepatic and/or whole-body insulin resistance (the forerunner of T2D) as well as increased bone resorption (indicating increased risk of osteoporosis) in patients with AD 2. evaluate the effect of TCS on skin and serum biomarkers of skin barrier function as well as skin microbiome composition
    Protection of trial subjects
    none
    Background therapy
    		 -
    Evidence for comparator
    		 Approved and internationally recommended treatment of atopic dermatitis through many years
    Actual start date of recruitment
    04 Feb 2019
    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
    Denmark: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    36
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from the outpatient clinic at Department of Dermatology and Allergy, Herlev-Gentofte Hospital, other Departments of Dermatology in the region of Copenhagen and Zealand, private dermatologic clinics in the area of Copenhagen, or by advertising.

    Pre-assignment
    Screening details
    		 Criteria: BMI < 30, AD at least 3 years, no prediabetes or diabetes, no other chronic inflammatory diseases (including but not limited to rheumatoid arthritis, inflammatory bowel disease etc) beside AD and non-treatment demanding rhinitis or asthma Two weeks wash-out without any topical anti-inflammatory treatment of atopic dermatitis

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

    Arms
    Arm title
    		 Pooled baseline
    Arm description
    		 -
    Arm type
    		 pooled baseline (no intervention yet)

    Investigational medicinal product name
    NONE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Other use
    Dosage and administration details
    NONE

    Number of subjects in period 1
    		Pooled baseline
    Started
    36
    Completed
    36
    Period 2
    Period 2 title
    After two weeks of treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Betamethasone 17-valerate
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Betnovate
    Investigational medicinal product code
    Other name
    Betamethasone 17-valerate
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Betnovate once daily plus a placebo once daily (2 weeks daily treatment + 4 weeks of twice weekly treatment) Betnovate (Betamethasone) 0.1% ointment (% (W/W) percent weight/weight) Cutaneous maximal use: 30 g * 1/day * 14 days + 30 g * 1/day * 2/week * 4 weeks = 660 gram(s)

    Arm title
    		 Tacrolimus
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Protopic
    Investigational medicinal product code
    Other name
    tacrolimus
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Protopic twice daily (2 weeks daily treatment + 4 weeks of twice weekly treatment) Protopic (Tacrolimus) 0.1 % ointment Cutaneous maximal use: 30 g * 2/day * 14 days + 30 g * 2/day * 2/week * 4 weeks = 1320 gram(s)

    Number of subjects in period 2
    		Betamethasone 17-valerate Tacrolimus
    Started
    18
    18
    Completed
    18
    18
    Period 3
    Period 3 title
    After six weeks of treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Betamethasone 17-valerate
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Betnovate
    Investigational medicinal product code
    Other name
    Betamethasone 17-valerate
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Betnovate once daily plus a placebo once daily (2 weeks daily treatment + 4 weeks of twice weekly treatment) Betnovate (Betamethasone) 0.1% ointment (% (W/W) percent weight/weight) Cutaneous maximal use: 30 g * 1/day * 14 days + 30 g * 1/day * 2/week * 4 weeks = 660 gram(s)

    Arm title
    		 Tacrolimus
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Protopic
    Investigational medicinal product code
    Other name
    tacrolimus
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Protopic twice daily (2 weeks daily treatment + 4 weeks of twice weekly treatment) Protopic (Tacrolimus) 0.1 % ointment Cutaneous maximal use: 30 g * 2/day * 14 days + 30 g * 2/day * 2/week * 4 weeks = 1320 gram(s)

    Number of subjects in period 3 [1]
    		Betamethasone 17-valerate Tacrolimus
    Started
    18
    17
    Completed
    18
    17
    Notes
    [1] - 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: One dropout after two weeks due to severe AD

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pooled baseline
    Reporting group description
    		 -

    Reporting group values
    		 Pooled baseline Total
    Number of subjects
    		 36 36
    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)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 36 36
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 26 (23 to 37) -
    Gender categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 17 17

    End points

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    End points reporting groups
    Reporting group title
    Pooled baseline
    Reporting group description
    		 -
    Reporting group title
    Betamethasone 17-valerate
    Reporting group description
    		 -

    Reporting group title
    Tacrolimus
    Reporting group description
    		 -
    Reporting group title
    Betamethasone 17-valerate
    Reporting group description
    		 -

    Reporting group title
    Tacrolimus
    Reporting group description
    		 -

    Primary: M-value

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    End point title
    		 M-value [1]
    End point description
    Insulin Sensitivity
    End point type
    Primary
    End point timeframe
    Baseline, week 2 and week 6
    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: se paper, link is provided
    End point values
    		 Pooled baseline
    Number of subjects analysed
    36
    Units: mg/kg/min
        geometric mean (confidence interval 95%)
    5.5 (4.7 to 6.4)
    No statistical analyses for this end point

    Primary: M-value after 2 weeks

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    End point title
    		 M-value after 2 weeks
    End point description
    change from baseline
    End point type
    Primary
    End point timeframe
    after two weeks of treatment
    End point values
    		 Betamethasone 17-valerate Tacrolimus
    Number of subjects analysed
    18
    18
    Units: percent
        number (confidence interval 95%)
    15.9 (0.8 to 33.4)
    8.5 (-5.7 to 24.8)
    Statistical analysis title
    		 Repeated measures ANOVA (mixed model)
    Comparison groups
    Tacrolimus v Betamethasone 17-valerate
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Primary: M-value after 6 weeks

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    End point title
    		 M-value after 6 weeks
    End point description
    End point type
    Primary
    End point timeframe
    after 6 weeks of treatment
    End point values
    		 Betamethasone 17-valerate Tacrolimus
    Number of subjects analysed
    18
    17
    Units: percent
        number (confidence interval 95%)
    18.8 (2.3 to 38.0)
    1.9 (-12.0 to 18.2)
    Statistical analysis title
    		 Repeated measures ANOVA (mixed model)
    Comparison groups
    Betamethasone 17-valerate v Tacrolimus
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    recorded until 5 times 75 hours after ended treatment (375 hours ~ 16 days)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 REDCap
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: burning and stinging in the skin is a well known side effect from tacrolimus and reported elsewhere

    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.
    These data are preliminary. Due to COVID-19, there was a delay in analysis of blood samples and data analysis.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36824052
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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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