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    Clinical Trial Results:
    Aprepitant – effect and safety in treatment of atopic dermatitis

    Summary
    EudraCT number
    		 2013-002029-40
    Trial protocol
    		 SE  
    Global end of trial date
    31 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Apr 2021
    First version publication date
    10 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Karolinska Institutet
    Sponsor organisation address
    17177, Stockholm, Sweden,
    Public contact
    Dep of dermatology, Karolinska Univ, Karolinska institutet, klas.nordlind@karolinska.se
    Scientific contact
    Dep of dermatology, Karolinska Univ, Karolinska institutet, klas.nordlind@karolinska.se
    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
    31 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of Aprepitant (Emend) on atpoic dermatitis and prutitus.
    Protection of trial subjects
    The protocol was approved by the local ethics committee and by the Medical Products Agency. Safety was assessed by recording adverse events at the second visit. The patients could also contact the clinic at any time during the treatment period if they observed any suspected side-effects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 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
    Sweden: 39
    Worldwide total number of subjects
    39
    EEA total number of subjects
    39
    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)
    39
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patients were recruited from dermatology clinics in the Stockholm area and examined at the Department of Dermatology, Karolinska University Hospital, Solna, Stockholm, Sweden, between October 2013 to March 2015.

    Pre-assignment
    Screening details
    		 Patients had a moderate–severe (SCORAD > 20) AD and diagnosis was determined according to the Williams criteria. Exclusion criteria: other concomitant diseases or medications (except for contraceptives), skin type 5–6 according to Fitzpatrick, skin infections, pregnancy, breast-feeding. The washout period for prior systemic treatment was 2 months.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment group
    Arm description
    		 The patients received 80 mg/day of aprepitant orally for 7 days in addition to standard topical treatment with a moderately strong steroid cream (hydrocortisone butyrate; Locoid®, LEO Pharma AB, Malmö, Sweden) and a moisturizer. 21 participants were enrolled, but 2 of those patients interrupted study treatment due to adverse events, specifically experienced transient side-effects, such as dizziness, impotence, headache (1 case) and lack of reactivity, dyspnoea and palpitations (the second case). Those 2 patients are not included in the baseline characteristics or analysis that is presented here.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aprepitant
    Investigational medicinal product code
    SUB20017
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    80 mg/day of aprepitant orally for 7 days.

    Investigational medicinal product name
    Hydrocortisone butyrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Standard topical treatment with a moderately strong steroid cream (hydrocortisone butyrate; Locoid®, LEO Pharma AB, Malmö, Sweden).

    Arm title
    		 Control group
    Arm description
    		 Standard topical treatment with a moderately strong steroid cream (hydrocortisone butyrate; Locoid®, LEO Pharma AB, Malmö, Sweden) and a moisturizer.
    Arm type
    		 Standard topical treatment

    Investigational medicinal product name
    Hydrocortisone butyrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Standard topical treatment with a moderately strong steroid cream (hydrocortisone butyrate; Locoid®, LEO Pharma AB, Malmö, Sweden).

    Number of subjects in period 1
    		Treatment group Control group
    Started
    19
    20
    Completed
    19
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment group
    Reporting group description
    		 The patients received 80 mg/day of aprepitant orally for 7 days in addition to standard topical treatment with a moderately strong steroid cream (hydrocortisone butyrate; Locoid®, LEO Pharma AB, Malmö, Sweden) and a moisturizer. 21 participants were enrolled, but 2 of those patients interrupted study treatment due to adverse events, specifically experienced transient side-effects, such as dizziness, impotence, headache (1 case) and lack of reactivity, dyspnoea and palpitations (the second case). Those 2 patients are not included in the baseline characteristics or analysis that is presented here.

    Reporting group title
    Control group
    Reporting group description
    		 Standard topical treatment with a moderately strong steroid cream (hydrocortisone butyrate; Locoid®, LEO Pharma AB, Malmö, Sweden) and a moisturizer.

    Reporting group values
    		 Treatment group Control group Total
    Number of subjects
    		 19 20 39
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 19 20 39
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 30.8 ( 8.4 ) 29.3 ( 9.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 16 23
        Male
    		 12 4 16
    OSCORAD
    OSCORAD = objective SCORing of Atopic Dermatitis
    Units: Score
        arithmetic mean (standard deviation)
    		 40.5 ( 12.0 ) 37.0 ( 11.3 ) -
    Visual analogue scale
    Units: Score
        arithmetic mean (standard deviation)
    		 5.5 ( 2.1 ) 6.7 ( 2.2 ) -
    IgE levels
    Units: kU/l
        arithmetic mean (standard deviation)
    		 903.7 ( 1.391 ) 876.5 ( 1.934 ) -
    Scratching movements
    Units: Registered number daily
        arithmetic mean (standard deviation)
    		 77.3 ( 97.9 ) 65.0 ( 100.9 ) -
    Montgomery Åsberg Depression Rating Scale
    Units: Score
        arithmetic mean (standard deviation)
    		 5.6 ( 4.9 ) 9.3 ( 8.9 ) -
    Hospital Anxiety and Depressive scale
    Units: Score
        arithmetic mean (standard deviation)
    		 3.4 ( 4.1 ) 6.6 ( 4.8 ) -
    Substance P
    Units: pmol/g
        arithmetic mean (standard deviation)
    		 98.7 ( 54.4 ) 105.6 ( 46.5 ) -

    End points

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    End points reporting groups
    Reporting group title
    Treatment group
    Reporting group description
    		 The patients received 80 mg/day of aprepitant orally for 7 days in addition to standard topical treatment with a moderately strong steroid cream (hydrocortisone butyrate; Locoid®, LEO Pharma AB, Malmö, Sweden) and a moisturizer. 21 participants were enrolled, but 2 of those patients interrupted study treatment due to adverse events, specifically experienced transient side-effects, such as dizziness, impotence, headache (1 case) and lack of reactivity, dyspnoea and palpitations (the second case). Those 2 patients are not included in the baseline characteristics or analysis that is presented here.

    Reporting group title
    Control group
    Reporting group description
    		 Standard topical treatment with a moderately strong steroid cream (hydrocortisone butyrate; Locoid®, LEO Pharma AB, Malmö, Sweden) and a moisturizer.

    Primary: OSCORAD Post-treatment

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    End point title
    		 OSCORAD Post-treatment
    End point description
    Objective SCORing of Atopic Dermatitis, arbitrary units (range 0–83)
    End point type
    Primary
    End point timeframe
    Day 7 of treatment.
    End point values
    		 Treatment group Control group
    Number of subjects analysed
    19
    20
    Units: Score
        arithmetic mean (standard deviation)
    32.0 ( 11.2 )
    26.7 ( 14.7 )
    Statistical analysis title
    		 Difference OSCORAD post-treatment
    Statistical analysis description
    Difference in OSCORAD between treatment and control after 7 days of treatment.
    Comparison groups
    Treatment group v Control group
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Visual analogue scale Post-treatment

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    End point title
    		 Visual analogue scale Post-treatment
    End point description
    Visual analogue scale, arbitrary units (range 0–10).
    End point type
    Secondary
    End point timeframe
    Day 7 of treatment.
    End point values
    		 Treatment group Control group
    Number of subjects analysed
    19
    20
    Units: Score
        arithmetic mean (standard deviation)
    3.8 ( 2.2 )
    4.1 ( 3.0 )
    Statistical analysis title
    		 Difference VAS post-treatment
    Statistical analysis description
    Difference in Visual Analogue Scale between treatment and control after 7 days of treatment.
    Comparison groups
    Treatment group v Control group
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: IgE levels Post-treatment

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    End point title
    		 IgE levels Post-treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7 of treatment.
    End point values
    		 Treatment group Control group
    Number of subjects analysed
    19
    20
    Units: kE/l
        arithmetic mean (standard deviation)
    937.9 ( 1.403 )
    821.1 ( 1.754 )
    Statistical analysis title
    		 Difference IgE levels post treatment
    Statistical analysis description
    Difference in IgE levels between treatment and control after 7 days of treatment.
    Comparison groups
    Treatment group v Control group
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Scratching movements Post-treatment

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    End point title
    		 Scratching movements Post-treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7 of treatment.
    End point values
    		 Treatment group Control group
    Number of subjects analysed
    19
    20
    Units: Registered number daily
        arithmetic mean (standard deviation)
    48.3 ( 62.6 )
    34.7 ( 45.0 )
    Statistical analysis title
    		 Difference Scratching movements post-treatment
    Statistical analysis description
    Difference in Scratching movements between treatment and control after 7 days of treatment.
    Comparison groups
    Treatment group v Control group
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Montgomery Åsberg Depression Rating Scale Post-treatment

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    End point title
    		 Montgomery Åsberg Depression Rating Scale Post-treatment
    End point description
    Montgomery Åsberg Depression Rating Scale, arbitrary units (range 0–54).
    End point type
    Secondary
    End point timeframe
    Day 7 of treatment.
    End point values
    		 Treatment group Control group
    Number of subjects analysed
    19
    20
    Units: Score
        arithmetic mean (standard deviation)
    4.0 ( 5.3 )
    6.5 ( 5.9 )
    Statistical analysis title
    		 Difference Depression scale post-treatment
    Statistical analysis description
    Difference in Montgomery Åsberg Depression Rating Scale between treatment and control after 7 days of treatment.
    Comparison groups
    Treatment group v Control group
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: HAD Post-treatment

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    End point title
    		 HAD Post-treatment
    End point description
    Hospital Anxiety and Depressive scale, arbitrary units (range 0–21).
    End point type
    Secondary
    End point timeframe
    Day 7 of treatment.
    End point values
    		 Treatment group Control group
    Number of subjects analysed
    19
    20
    Units: Score
        arithmetic mean (standard deviation)
    3.5 ( 3.2 )
    4.8 ( 3.7 )
    Statistical analysis title
    		 Difference HAD post-treatment
    Statistical analysis description
    Difference in HAD between treatment and control after 7 days of treatment.
    Comparison groups
    Treatment group v Control group
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Substance P Post-treatment

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    End point title
    		 Substance P Post-treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7 of treatment.
    End point values
    		 Treatment group Control group
    Number of subjects analysed
    19
    20
    Units: pmol/g
        arithmetic mean (standard deviation)
    97.6 ( 50.3 )
    91.0 ( 32.7 )
    Statistical analysis title
    		 Difference Substance P post-treatment
    Statistical analysis description
    Difference in Substance P between treatment and control after 7 days of treatment.
    Comparison groups
    Treatment group v Control group
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Study start to day 7 of treatment.
    Adverse event reporting additional description
    Recording of adverse events was done at the second visit (day 7 of treatment). The patients could also contact the clinic at any time during the treatment period if they observed any suspected side-effects. No frequency threshold was used, as all adverse events that arise were reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD
    Dictionary version
    10-SE
    Reporting groups
    Reporting group title
    Treatment group
    Reporting group description
    		 -

    Reporting group title
    Control group
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment group Control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treatment group Control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 21 (61.90%)
    0 / 20 (0.00%)
    Product issues
    Headache, fatigue, dizziness, elevated liver enzymes, palpitations, dyspnoea...
    Additional description: 13/21 participants in treatment reported trancient AE: headache, fatigue, dizziness, elevated liver enzymes, palpitations, dyspnoea, altered ability to react, obstipation, stomach-ache, periocular dermatitis, erectile dysfunction, lack of reactivity.
         subjects affected / exposed
    13 / 21 (61.90%)
    0 / 20 (0.00%)
         occurrences all number
    13
    0

    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.
    Patients in this study generally did not have worse than moderate pruritus, which may have had an impact on the results. There were different sex distributions in the 2 groups, thus it cannot be excluded that aprepitant exerts sex-specific effects.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29182791
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