Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page

    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
    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.

    European Medicines Agency © 1995-Sat May 03 19:04:46 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA