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    Clinical Trial Results:
    A Phase 2, multicenter, prospective, randomized, double-blind, Minoxidil and vehicle controlled, dose-ranging study to evaluate the efficacy and safety of CB-03-01 (Cortexolone 17α-propionate) solution for the treatment of androgenetic alopecia in females

    Summary
    EudraCT number
    		 2019-000950-78
    Trial protocol
    		 DE  
    Global end of trial date
    21 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Oct 2022
    First version publication date
    25 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CB-03-01/35
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cassiopea S.p.A:
    Sponsor organisation address
    Via C. Colombo, 1, Lainate/Milan, Italy, 20045
    Public contact
    R&D Department, Cassiopea S.p.A., +39 0286891124, dermatology@cosmopharma.com
    Scientific contact
    R&D Department, Cassiopea S.p.A., +39 0286891124, dermatology@cosmopharma.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Apr 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to evaluate the efficacy and safety of Clascoterone (CB-03-01) topical solution 5% and 7.5% BID (twice a day) dosing compared to the Minoxidil solution 2% (BID) and the vehicle solution (BID) for the treatment of androgenetic alopecia (AGA) in females.
    Protection of trial subjects
    Before being admitted to the study the subjects were informed in detail about the significance, nature, scope and possible risks of the study. Written information was available for this purpose. Subjects were free to terminate their participation in the study at any time without personal disadvantages and without giving reasons. The subjects were informed that all study data would have been collected and stored in an electronic database, pseudoanonymized, and handled in the strictest confidence. Randomized subjects were provided with instruction sheet, diary and study subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency.
    Background therapy
    		 No background therapy foreseen in this study.
    Evidence for comparator
    		 Minoxidil was used as comparator being an available treatment on the market for the AGA
    Actual start date of recruitment
    20 Nov 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
    Germany: 293
    Worldwide total number of subjects
    293
    EEA total number of subjects
    293
    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)
    293
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was carried out at seven study centers in Germany. A total of 329 subjects were screened and 293 randomized. The enrolment/randomization period included about 10 months instead of the planned 6 months as there was a temporary recruitment halt of about two months due to the COVID-19 pandemic.

    Pre-assignment
    Screening details
    		 Eligible subjects were adult (18 to 55 years of age) females who had to show and had a history of hair density reduction in the centroparietal region, as classified by the Savin Density Scale. The screening period ranged from Day -14 to -3. A washout phase from prohibited medications or treatments was foreseen, if necessary.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    The various concentrations of CB-03-01 solution, Minoxidil and vehicle solution were packaged in identical 60 ml glass amber bottles and the treatment was randomly assigned to the subjects through a centralized randomization list.Treatment group designation at the site level remained blinded until the final database was locked. Sealed Emergency Unblinding Forms were available for each kit at the study sites for emergency unblinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CB-03-01 solution, 5%
    Arm description
    		 Clascoterone (CB-03-01) solution, 5% BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clascoterone solution 5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    1mL of solution applied to the balding areas of the scalp (centroparietal region) twice daily over a period of 6 months

    Arm title
    		 CB-03-01 solution, 7.5%
    Arm description
    		 Clascoterone (CB-03-01) solution 7.5% BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clascoterone solution 7.5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    1mL of solution applied to the balding areas of the scalp (centroparietal region) twice daily over a period of 6 months

    Arm title
    		 Minoxidil solution, 2%
    Arm description
    		 Minoxidil solution 2% BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Minixidil solution 2%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    1mL of solution applied to the balding areas of the scalp (centroparietal region) twice daily over a period of 6 months

    Arm title
    		 Vehicle solution
    Arm description
    		 Clascoterone Vehicle solution BID (twice a day)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vehicle solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    1mL of solution applied to the balding areas of the scalp (centroparietal region) twice daily over a period of 6 months

    Number of subjects in period 1
    		CB-03-01 solution, 5% CB-03-01 solution, 7.5% Minoxidil solution, 2% Vehicle solution
    Started
    72
    73
    75
    73
    Completed
    62
    66
    70
    68
    Not completed
    10
    7
    5
    5
         Consent withdrawn by subject
    3
    1
    2
    1
         Adverse event, non-fatal
    3
    3
    2
    -
         Other
    1
    3
    1
    4
         Pregnancy
    1
    -
    -
    -
         Lost to follow-up
    2
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CB-03-01 solution, 5%
    Reporting group description
    		 Clascoterone (CB-03-01) solution, 5% BID

    Reporting group title
    CB-03-01 solution, 7.5%
    Reporting group description
    		 Clascoterone (CB-03-01) solution 7.5% BID

    Reporting group title
    Minoxidil solution, 2%
    Reporting group description
    		 Minoxidil solution 2% BID

    Reporting group title
    Vehicle solution
    Reporting group description
    		 Clascoterone Vehicle solution BID (twice a day)

    Reporting group values
    		 CB-03-01 solution, 5% CB-03-01 solution, 7.5% Minoxidil solution, 2% Vehicle solution Total
    Number of subjects
    		 72 73 75 73 293
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 72 73 75 73 293
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.3 ± 11.4 40.5 ± 10.5 39.9 ± 10.4 41.8 ± 9.8 -
    Gender categorical
    Units: Subjects
        Female
    		 72 73 75 73 293
        Male
    		 0 0 0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 0 0 3 4
        Not Hispanic or Latino
    		 71 73 75 70 289
    Race
    Units: Subjects
        White
    		 67 73 74 71 285
        Asian
    		 3 0 1 1 5
        African American
    		 0 0 0 1 1
        Other
    		 2 0 0 0 2
    Savin Density Scale
    The Savin scale measures overall thinning of the crown scalp and consists of eight crown density images reflecting a range from no hair loss to severe hair loss (Density stages picture nos. 1, 2, 3, 4, 5, 6, 7, and 8). Eligible for this study were only subjects being classified having stage picture nos. 3–6 .
    Units: Subjects
        Stage 3
    		 30 27 39 30 126
        Stage 4
    		 24 34 27 32 117
        Stage 5
    		 14 11 7 11 43
        Stage 6
    		 4 1 2 0 7
    Postmenopausal hormonal status
    Units: Subjects
        No
    		 55 60 57 58 230
        Yes
    		 17 13 18 15 63
    Subject analysis sets

    Subject analysis set title
    Efficay Population - CB-03-01 solution, 5%
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects treated with CB-03-01 solution 5% and included in the PP population

    Subject analysis set title
    Efficay Population - CB-03-01 solution, 7.5%
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects treated with CB-03-01 solution 7.5% and included in the PP population

    Subject analysis set title
    Efficay Population - Minoxidil solution, 2%
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects treated with Minoxidil solution, 2% and included in the PP population

    Subject analysis set title
    Efficay Population - Vehicle solution
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects treated with vehicle solution and included in the PP population

    Subject analysis sets values
    		 Efficay Population - CB-03-01 solution, 5% Efficay Population - CB-03-01 solution, 7.5% Efficay Population - Minoxidil solution, 2% Efficay Population - Vehicle solution
    Number of subjects
    61
    65
    66
    64
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    61
    65
    66
    64
        From 65-84 years
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    40.3 ± 11.3
    40.1 ± 10.5
    39.9 ± 10.2
    42.6 ± 9.6
    Gender categorical
    Units: Subjects
        Female
    61
    65
    66
    64
        Male
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    1
    0
    0
    0
        Not Hispanic or Latino
    60
    65
    66
    64
    Race
    Units: Subjects
        White
    58
    65
    65
    63
        Asian
    2
    0
    1
    0
        African American
    0
    0
    0
    1
        Other
    1
    0
    0
    0
    Savin Density Scale
    The Savin scale measures overall thinning of the crown scalp and consists of eight crown density images reflecting a range from no hair loss to severe hair loss (Density stages picture nos. 1, 2, 3, 4, 5, 6, 7, and 8). Eligible for this study were only subjects being classified having stage picture nos. 3–6 .
    Units: Subjects
        Stage 3
    25
    23
    35
    27
        Stage 4
    21
    30
    24
    28
        Stage 5
    12
    11
    5
    9
        Stage 6
    3
    1
    2
    0
    Postmenopausal hormonal status
    Units: Subjects
        No
    47
    54
    51
    49
        Yes
    14
    11
    15
    15

    End points

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    End points reporting groups
    Reporting group title
    CB-03-01 solution, 5%
    Reporting group description
    		 Clascoterone (CB-03-01) solution, 5% BID

    Reporting group title
    CB-03-01 solution, 7.5%
    Reporting group description
    		 Clascoterone (CB-03-01) solution 7.5% BID

    Reporting group title
    Minoxidil solution, 2%
    Reporting group description
    		 Minoxidil solution 2% BID

    Reporting group title
    Vehicle solution
    Reporting group description
    		 Clascoterone Vehicle solution BID (twice a day)

    Subject analysis set title
    Efficay Population - CB-03-01 solution, 5%
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects treated with CB-03-01 solution 5% and included in the PP population

    Subject analysis set title
    Efficay Population - CB-03-01 solution, 7.5%
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects treated with CB-03-01 solution 7.5% and included in the PP population

    Subject analysis set title
    Efficay Population - Minoxidil solution, 2%
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects treated with Minoxidil solution, 2% and included in the PP population

    Subject analysis set title
    Efficay Population - Vehicle solution
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects treated with vehicle solution and included in the PP population

    Primary: Non-vellus TAHC – Change from Baseline at Month 6 for active treatment groups in comparison to vehicle group – PP

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    End point title
    		 Non-vellus TAHC – Change from Baseline at Month 6 for active treatment groups in comparison to vehicle group – PP
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to month 6
    End point values
    		 Efficay Population - CB-03-01 solution, 5% Efficay Population - CB-03-01 solution, 7.5% Efficay Population - Minoxidil solution, 2% Efficay Population - Vehicle solution
    Number of subjects analysed
    61
    65
    66
    64
    Units: TAHC
        number (confidence interval 95%)
    7.1 (4.0 to 10.1)
    2.8 (-0.5 to 6.2)
    18.2 (13.7 to 22.7)
    9.1 (5.2 to 12.9)
    Statistical analysis title
    		 Change from Baseline in non-vellus TAHC at Month 6
    Statistical analysis description
    Non-vellus TAHC - Change from Baseline at Month 6 in comparison to vehicle was evaluated in PP by restricted maximum likelihood (REML)-based MMRM (8) where the model includes treatment, visit, the treatment by visit interaction, and analysis center as factors and the baseline non-vellus TAHC and baseline non-vellus TAHC-by-visit interaction as the covariates. An unstructured covariance structure of within subject errors and the Kenward-Roger degrees of freedom approximation was used.
    Comparison groups
    Efficay Population - CB-03-01 solution, 5% v Efficay Population - CB-03-01 solution, 7.5% v Efficay Population - Minoxidil solution, 2% v Efficay Population - Vehicle solution
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 ≤ 0.05
    Method
    		 paired t-test
    Confidence interval
    Notes
    [1] - No confirmatory hypotheses were formulated for this exploratory study. The analyses were conducted without adjustment for multiplicity and were interpreted descriptively. The covariance structure converging to the best fit, as determined by Akaike’s information criterion, was used as the primary analysis. Pairwise comparisons for the LSM between the active treatments and the vehicle were evaluated. Within treatment group comparisons for non-vellus TAHC vs Baseline were based on paired t-test

    Primary: Hair Growth Assessment (HGA) at Month 6 for active treatment groups in comparison to vehicle group - PP

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    End point title
    		 Hair Growth Assessment (HGA) at Month 6 for active treatment groups in comparison to vehicle group - PP
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to month 6
    End point values
    		 Efficay Population - CB-03-01 solution, 5% Efficay Population - CB-03-01 solution, 7.5% Efficay Population - Minoxidil solution, 2% Efficay Population - Vehicle solution
    Number of subjects analysed
    61
    65
    66
    64
    Units: HGA - Observed cases (OC)
        Hair growth increased
    35
    43
    50
    34
        No change in hair growth
    22
    19
    15
    21
        Hair growth decreased
    4
    3
    1
    9
    Statistical analysis title
    		 Hair Growth Assessment (HGA) at Month 6
    Statistical analysis description
    The frequency distribution of HGA score at Month 6 was evaluated using a CMH mean score test stratified by analysis center using modified ridit score for between-group comparisons. Pairwise comparisons between the active treatment groups and vehicle were evaluated. If the tables were sparse, Fisher's Exact test might have been used or categories might have been collapsed for analysis.
    Comparison groups
    Efficay Population - CB-03-01 solution, 5% v Efficay Population - CB-03-01 solution, 7.5% v Efficay Population - Minoxidil solution, 2% v Efficay Population - Vehicle solution
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 ≤ 0.05
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - No confirmatory hypotheses were formulated for this exploratory study. The analyses specified in the following were conducted without adjustment for multiplicity and were interpreted descriptively.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Collection of information on the medical condition of subjects begun following the subject's written informed consent to participate in the study and ended at the date of the final study visit or later in case a fu was needed.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    CB-03-01 solution, 5%
    Reporting group description
    		 Clascoterone (CB-03-01) solution, 5% BID

    Reporting group title
    CB-03-01 solution, 7.5%
    Reporting group description
    		 Clascoterone (CB-03-01) solution 7.5% BID

    Reporting group title
    Minoxidil solution, 2%
    Reporting group description
    		 Minoxidil solution 2% BID

    Reporting group title
    Vehicle solution
    Reporting group description
    		 Clascoterone Vehicle solution BID (twice a day)

    Serious adverse events
    		 CB-03-01 solution, 5% CB-03-01 solution, 7.5% Minoxidil solution, 2% Vehicle solution
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 73 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Heavy menstrual bleeding
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CB-03-01 solution, 5% CB-03-01 solution, 7.5% Minoxidil solution, 2% Vehicle solution
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 72 (18.06%)
    11 / 74 (14.86%)
    25 / 74 (33.78%)
    14 / 73 (19.18%)
    Investigations
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 74 (0.00%)
    5 / 74 (6.76%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    5
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 72 (4.17%)
    4 / 74 (5.41%)
    6 / 74 (8.11%)
    1 / 73 (1.37%)
         occurrences all number
    8
    11
    6
    1
    General disorders and administration site conditions
    Application site pruritus
         subjects affected / exposed
    1 / 72 (1.39%)
    2 / 74 (2.70%)
    4 / 74 (5.41%)
    6 / 73 (8.22%)
         occurrences all number
    1
    2
    4
    8
    Application site alopecia
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 74 (1.35%)
    4 / 74 (5.41%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    4
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 74 (0.00%)
    0 / 74 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 72 (11.11%)
    4 / 74 (5.41%)
    6 / 74 (8.11%)
    7 / 73 (9.59%)
         occurrences all number
    9
    4
    6
    7

    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.
    None reported
    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.

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