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    Clinical Trial Results:
    Safety and Effect of LEO 90100 aerosol foam on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to < 17 Years) with Plaque Psoriasis A phase 2 trial evaluating the safety and efficacy of once daily topical treatment with LEO 90100 aerosol foam in adolescent subjects with plaque psoriasis An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis

    Summary
    EudraCT number
    2015-000839-33
    Trial protocol
    NL   PL  
    Global end of trial date
    28 Mar 2018

    Results information
    Results version number
    v4(current)
    This version publication date
    30 Jan 2019
    First version publication date
    14 Oct 2018
    Other versions
    v1 , v2 , v3
    Version creation reason
    • Correction of full data set
    Change made to the endpoint description for Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4 to align with comments received from clinicaltrials.gov.

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0053-1108
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02387853
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    LEO Pharma A/S
    Sponsor organisation address
    Industriparken 55, Ballerup, Denmark, 2750
    Public contact
    Clinical Disclosure Specialist, LEO Pharma A/S, +45 44945888, disclosure@leo-pharma.com
    Scientific contact
    Clinical Disclosure Specialist, LEO Pharma A/S, +45 44945888, disclosure@leo-pharma.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
    22 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Mar 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the safety of once daily use of LEO 90100 in adolescent subjects (aged 12 to < 17 years) with plaque psoriasis on the body and scalp.
    Protection of trial subjects
    This clinical trial was conducted in accordance with the revision current at the start of the trial of the World Medical Association’s Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. All subjects received written and verbal information concerning the clinical trial. This information emphasised that participation in the clinical trial was voluntary and that the subject could withdraw from the clinical trial at any time and for any reason. All subjects and their legally acceptable representatives were given an opportunity to ask questions and were given sufficient time to consider before consenting. Subjects who were not of legal age gave assent to their participation in the trial. The subject’s and legally acceptable representatives' signed and dated informed consent and assent to participate in the clinical trial were obtained prior to any trial related activities being carried out in accordance with ICH Good Clinical Practice (GCP) Section 4.8 and all applicable laws and regulations. Overdosage with calcipotriol may be associated with hypercalcaemia, and clinically important hypercalcaemia could be managed at the investigator’s discretion with rehydration, biphosphonate administration or according to local instructions. Overdosage with betamethasone dipropionate may result in suppression of the pituitary adrenal function, and could be treated symptomatically at the investigator's discretion. There is a risk of allergic hypersensitivity reactions with administration of Cortrosyn®/Synacthen®. Prior to the injection of Cortrosyn®/Synacthen®, the physician administering the injection was prepared to treat any possible hypersensitivity reactions.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Mar 2016
    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
    United States: 3
    Country: Number of subjects enrolled
    Netherlands: 9
    Country: Number of subjects enrolled
    Poland: 71
    Country: Number of subjects enrolled
    Romania: 34
    Worldwide total number of subjects
    117
    EEA total number of subjects
    114
    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)
    117
    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
    -

    Pre-assignment
    Screening details
    Male/female 12-17 years, psoriasis on body and scalp Subj. not performing HPA axis test: Plaque psoriasis ≥2% BSA, ≥10% of scalp, ≥ mild severity Subj. performing HPA axis test: Plaque psoriasis ≥10% BSA, ≥20% of scalp, ≥ moderate severity, normal HPA-axis function 117 screened. 106 assigned to treatment, 8 screening failures, 3 withdrew consent

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

    Arms
    Arm title
    LEO 90100
    Arm description
    This arm contains all 106 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 33 subjects in this arm performed additional baseline and post-baseline HPA axis assessments and constitute the per protocol analysis set.
    Arm type
    Experimental

    Investigational medicinal product name
    LEO 90100
    Investigational medicinal product code
    Other name
    Enstilar®
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Topical use
    Dosage and administration details
    LEO 90100 is formulated as an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate). LEO 90100 was applied once daily to body and scalp psoriasis lesions. Subjects in the HPA axis cohort were to continue the treatment, even if their lesions had cleared at Week 2. Subjects in the non-HPA axis cohort were allowed to discontinue treatment if the psoriasis lesions had cleared at Week 2 (according to the investigator), but should stay in the trial. During periods of discontinuation of treatment, those cleared subjects were to restart treatment if the psoriasis re-appeared.

    Number of subjects in period 1 [1]
    LEO 90100
    Started
    106
    Completed
    103
    Not completed
    3
         Consent withdrawn by subject
    3
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The worldwide number of enrolled subjects include all subjects who provided consent for participation in the trial and were screened. Out of the 117 subjects who were screened, 106 subjects met all inclusion criteria and none of the exclusion criteria, and were assigned to treatment. These 106 subjects are subjects are included in the data for the baseline period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    -

    Reporting group values
    Overall period Total
    Number of subjects
    106 106
    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)
    106 106
        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)
    14.2 ± 1.4 -
    Gender categorical
    Units: Subjects
        Female
    61 61
        Male
    45 45
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All subjects assigned to treatment are included in the full analysis set and were analysed for efficacy. 106 subjects were assigned to the treatment. Thus the full analysis set consists of 106 subjects.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety analysis set is defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. 106 subjects were assigned to treatment and had safety information collected. For 1 subject it was unknown whether any IMP was applied, but since it could neither be confirmed nor denied that the subject did not apply IMP, this subject was included in the safety analysis set. Therefore, the safety analysis set comprised 106 subjects. The analysis of the results from the ACTH-challenge test is based on the per protocol analysis set and not on the safety analysis set.

    Subject analysis set title
    Per protocol analysis set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    For the analysis of the results from the ACTH-challenge test, a per protocol analysis set was defined by including subjects undergoing HPA axis assessments from the full analysis set, however excluding the subjects who: • Received no treatment with the IMP • Provided no results for the ACTH-challenge test at Week 4 • And/or do not fulfil inclusion criterion 17 concerning evidence of normal adrenal function at baseline: Normal HPA axis function at SV2 (serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge). A total of 34 subjects in the full analysis set were assigned to perform the ACTH challenge test. 33 subjects provided data for the ACTH-challenge, thus the per protocol analysis set comprises 33 subjects.

    Subject analysis set title
    24-hour urine HPA set
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    24-hour urine samples were only collected from subjects in the HPA axis cohort. All 34 subjects in the HPA axis cohort were included in this analysis set, referred to as the ‘24-hour urine HPA set’.

    Subject analysis set title
    Spot urine non-HPA set
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Some analytes in the spot urine samples (calcium, phosphate, and creatinine) were only to be measured in subjects in the non-HPA axis cohort. This analysis set is called ‘spot urine non-HPA set’ and comprised 72 subjects.

    Subject analysis sets values
    Full analysis set Safety analysis set Per protocol analysis set 24-hour urine HPA set Spot urine non-HPA set
    Number of subjects
    106
    106
    33
    34
    72
    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)
    106
    106
    33
        Adults (18-64 years)
    0
    0
    0
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    14.2 ± 1.4
    14.2 ± 1.4
    14.2 ± 1.3
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    61
    61
    16
        Male
    45
    45
    17

    End points

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    End points reporting groups
    Reporting group title
    LEO 90100
    Reporting group description
    This arm contains all 106 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 33 subjects in this arm performed additional baseline and post-baseline HPA axis assessments and constitute the per protocol analysis set.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All subjects assigned to treatment are included in the full analysis set and were analysed for efficacy. 106 subjects were assigned to the treatment. Thus the full analysis set consists of 106 subjects.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety analysis set is defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. 106 subjects were assigned to treatment and had safety information collected. For 1 subject it was unknown whether any IMP was applied, but since it could neither be confirmed nor denied that the subject did not apply IMP, this subject was included in the safety analysis set. Therefore, the safety analysis set comprised 106 subjects. The analysis of the results from the ACTH-challenge test is based on the per protocol analysis set and not on the safety analysis set.

    Subject analysis set title
    Per protocol analysis set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    For the analysis of the results from the ACTH-challenge test, a per protocol analysis set was defined by including subjects undergoing HPA axis assessments from the full analysis set, however excluding the subjects who: • Received no treatment with the IMP • Provided no results for the ACTH-challenge test at Week 4 • And/or do not fulfil inclusion criterion 17 concerning evidence of normal adrenal function at baseline: Normal HPA axis function at SV2 (serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge). A total of 34 subjects in the full analysis set were assigned to perform the ACTH challenge test. 33 subjects provided data for the ACTH-challenge, thus the per protocol analysis set comprises 33 subjects.

    Subject analysis set title
    24-hour urine HPA set
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    24-hour urine samples were only collected from subjects in the HPA axis cohort. All 34 subjects in the HPA axis cohort were included in this analysis set, referred to as the ‘24-hour urine HPA set’.

    Subject analysis set title
    Spot urine non-HPA set
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Some analytes in the spot urine samples (calcium, phosphate, and creatinine) were only to be measured in subjects in the non-HPA axis cohort. This analysis set is called ‘spot urine non-HPA set’ and comprised 72 subjects.

    Primary: Number of Subjects with Adverse Events (AEs)

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    End point title
    Number of Subjects with Adverse Events (AEs) [1]
    End point description
    Number of adverse events in the safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
    End point type
    Primary
    End point timeframe
    From Week -1 to Week 8
    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: No statistical analysis is required for this end point.
    End point values
    Safety analysis set
    Number of subjects analysed
    106
    Units: Number of subjects
        Upper respiratory tract infection
    8
        Nasopharyngitis
    4
        Folliculitis
    1
        Impetigo
    1
        Oral herpes
    1
        Pharyngitis
    1
        Pulpitis dental
    1
        Rhinitis
    1
        Acne
    2
        Erythema
    1
        Pruritus generalised
    1
        Psoriasis
    1
        Skin reaction
    1
        Application site pain
    1
        Product physical consistency issue
    1
        Arthralgia
    1
        Myalgia
    1
        Myopia
    1
        Arthropod bite
    1
        Haemangioma of liver
    1
        Skin neoplasm excision
    1
    No statistical analyses for this end point

    Primary: Number of Subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4

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    End point title
    Number of Subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 [2]
    End point description
    Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline.
    End point type
    Primary
    End point timeframe
    30 minutes after ACTH-challenge at Week 4
    Notes
    [2] - 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: No statistical analysis is required for this end point.
    End point values
    Per protocol analysis set
    Number of subjects analysed
    33
    Units: Number of subjects
        Serum cortisol equal to or below 18 mcg/dl
    3
        Serum cortisol above 18 mcg/dl
    30
    No statistical analyses for this end point

    Primary: Change in albumin-corrected serum calcium from baseline to Week 4

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    End point title
    Change in albumin-corrected serum calcium from baseline to Week 4 [3]
    End point description
    Change in albumin-corrected serum calcium from baseline to Week 4 in safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
    End point type
    Primary
    End point timeframe
    From baseline to Week 4
    Notes
    [3] - 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: No statistical analysis is required for this end point.
    End point values
    Safety analysis set
    Number of subjects analysed
    101
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.016 ± 0.119
    No statistical analyses for this end point

    Primary: Change in calcium excretion in 24-hour urine from baseline to Week 4

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    End point title
    Change in calcium excretion in 24-hour urine from baseline to Week 4 [4]
    End point description
    Change in calcium excretion in 24-hour urine collection from baseline to Week 4 in the 24-hour urine HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing.
    End point type
    Primary
    End point timeframe
    From baseline to Week 4
    Notes
    [4] - 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: No statistical analysis is required for this end point.
    End point values
    24-hour urine HPA set
    Number of subjects analysed
    32
    Units: mmol/24hr
        arithmetic mean (standard deviation)
    -0.335 ± 2.076
    No statistical analyses for this end point

    Primary: Change in calcium:creatinine ratio in 24-hour urine from baseline to Week 4

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    End point title
    Change in calcium:creatinine ratio in 24-hour urine from baseline to Week 4 [5]
    End point description
    Change in calcium:creatinine ratio in 24-hour urine collection from baseline to Week 4 in the 24-hour urine in HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing.
    End point type
    Primary
    End point timeframe
    From baseline to Week 4
    Notes
    [5] - 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: No statistical analysis is required for this end point.
    End point values
    24-hour urine HPA set
    Number of subjects analysed
    31
    Units: mmol/g
        arithmetic mean (standard deviation)
    -0.2892 ± 2.1185
    No statistical analyses for this end point

    Secondary: Number of Subjects with serum cortisol concentration ≤18 mcg/dL at both 30 and 60 minutes after ACTH-challenge at Week 4

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    End point title
    Number of Subjects with serum cortisol concentration ≤18 mcg/dL at both 30 and 60 minutes after ACTH-challenge at Week 4
    End point description
    Number of subjects with serum cortisol concentration ≤18 mcg/dL at both 30 and 60 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of adrenal function at baseline.
    End point type
    Secondary
    End point timeframe
    30 and 60 minutes after ACTH-challenge at Week 4
    End point values
    Per protocol analysis set
    Number of subjects analysed
    33
    Units: Number of subjects
        Serum cortisol equal to or below 18 mcg/dL
    1
        Serum cortisol above 18 mcg/dl
    32
    No statistical analyses for this end point

    Secondary: Change in calcium:creatinine ratio in spot urine samples from baseline to Week 4

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    End point title
    Change in calcium:creatinine ratio in spot urine samples from baseline to Week 4
    End point description
    Change in calcium:creatinine ratio in spot urine samples from baseline to Week 4 in the spot urine non-HPA set, defined as all subjects in the safety analysis set who did not undergo HPA-axis testing.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 4
    End point values
    Spot urine non-HPA set
    Number of subjects analysed
    48
    Units: mmol/g
        arithmetic mean (standard deviation)
    0.4620 ± 1.8892
    No statistical analyses for this end point

    Secondary: Number of Subjects with ‘treatment success’ according to Physician's Global Assessment (PGA) on body

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    End point title
    Number of Subjects with ‘treatment success’ according to Physician's Global Assessment (PGA) on body
    End point description
    Number of subjects with ‘treatment success’ according to Physician's Global Assessment (PGA) on body in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Full analysis set
    Number of subjects analysed
    103 [6]
    Units: Number of subjects
        Yes
    74
        No
    29
    Notes
    [6] - 3 subjects withdrew from the trial prior to Week 4 visit, 103 subjects were included in the analysis
    No statistical analyses for this end point

    Secondary: Number of Subjects with ‘treatment success’ according to Physician's Global Assessment (PGA) on scalp

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    End point title
    Number of Subjects with ‘treatment success’ according to Physician's Global Assessment (PGA) on scalp
    End point description
    Number of subjects with ‘treatment success’ according to Physician's Global Assessment (PGA) on Scalp in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Full analysis set
    Number of subjects analysed
    103 [7]
    Units: Number of subjects
        Yes
    78
        No
    25
    Notes
    [7] - 3 subjects withdrew from the trial prior to Week 4 visit, 103 subjects were included in the analysis
    No statistical analyses for this end point

    Secondary: Percentage change in PASI from baseline to Week 4

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    End point title
    Percentage change in PASI from baseline to Week 4
    End point description
    Percentage change in Psoriasis area and severity index (PASI) score from baseline to Week 4. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris. Body surface is divided in 4 ares: head (incl. neck), arms (incl. hands), trunk (incl. flexures) and legs (incl. buttocks and feet). Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated. The total PASI score is calculated from each area's score. The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 4
    End point values
    Full analysis set
    Number of subjects analysed
    103 [8]
    Units: Percentage change in PASI
        arithmetic mean (standard deviation)
    -82.05 ± 17.87
    Notes
    [8] - 3 subjects withdrew from the trial prior to Week 4 visit, 103 subjects were included in the analysis
    No statistical analyses for this end point

    Secondary: Number of Subjects with ‘treatment success’ according to the Subject’s Global Assessment of disease severity on the body at Week 4

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    End point title
    Number of Subjects with ‘treatment success’ according to the Subject’s Global Assessment of disease severity on the body at Week 4
    End point description
    Number of subjects with ‘treatment success’ according to the Subject’s Global Assessment of disease severity on the body at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Full analysis set
    Number of subjects analysed
    103 [9]
    Units: Number of subjects
        Yes
    86
        No
    17
    Notes
    [9] - 3 subjects withdrew from the trial prior to Week 4 visit, 103 subjects were included in the analysis
    No statistical analyses for this end point

    Secondary: Number of Subjects With ‘treatment success’ according to the Subject’s Global Assessment of disease severity on the scalp at Week 4

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    End point title
    Number of Subjects With ‘treatment success’ according to the Subject’s Global Assessment of disease severity on the scalp at Week 4
    End point description
    Number of subjects with ‘treatment success’ according to the Subject’s Global Assessment of disease severity on the scalp at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Full analysis set
    Number of subjects analysed
    103 [10]
    Units: Number of subjects
        Yes
    84
        No
    19
    Notes
    [10] - 3 subjects withdrew from the trial prior to Week 4 visit, 103 subjects were included in the analysis
    No statistical analyses for this end point

    Secondary: Change in itch as assessed on a visual analog scale (VAS) from baseline to Week 4

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    End point title
    Change in itch as assessed on a visual analog scale (VAS) from baseline to Week 4
    End point description
    Change in itch as assessed on a visual analog scale (VAS) from baseline to Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. The assessments were made on a 100 mm (100 mm = 10 cm) horizontal VAS anchored at 0 ('no itch at all') and 10 ('worst itch you can imagine'). Subjects were asked to put a vertical line on the scale at the spot he/she felt best reflected the maximal itch intensity during the last 24 hours. The distance from 0 to the subject's indication line was measured in mm, thus higher scores indicated a worse outcome.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 4
    End point values
    Full analysis set
    Number of subjects analysed
    103 [11]
    Units: mm on VAS scale
        arithmetic mean (standard deviation)
    -32.5 ± 27.3
    Notes
    [11] - 3 subjects withdrew from the trial prior to Week 4 visit, 103 subjects were included in the analysis
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day -28 up to Day 56
    Adverse event reporting additional description
    AEs/SAEs were followed up until final outcome was determined. After a subject left the trial, investigator followed up all SAEs and AEs deemed possibly/probably related to IMP for 14± 2 days or until final outcome was determined, whichever came first.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    All subjects
    Reporting group description
    This arm contains all 106 subjects that were assigned to treatment and constitutes the safety analysis set.

    Serious adverse events
    All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 106 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 106 (20.75%)
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Surgical and medical procedures
    Skin neoplasm excision
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma of liver
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Eye disorders
    Myopia
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Product physical consistency issue
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    2 / 106 (1.89%)
         occurrences all number
    2
    Erythema
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Pruritus generalised
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Skin reaction
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 106 (7.55%)
         occurrences all number
    8
    Nasopharyngitis
         subjects affected / exposed
    4 / 106 (3.77%)
         occurrences all number
    4
    Folliculitis
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Impetigo
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Pulpitis dental
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1
    Psoriasis
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jul 2015
    The amendment was triggered by comments received from the FDA. - Local safety and tolerability assessment was added. - The use of Synacthen® was added (European sites only) - It was specified that subjects in the HPA axis cohort should continue their treatment even if their lesions had cleared at Week 2. - A physical examination was added at Week 4 and at early withdrawal. - Vital signs were added at baseline and Week 2 - Temperature (oral or ear) was added to vital signs. - The PGA scale (Table 12) was updated to also include levels 0 (clear) and 1 (almost clear).
    18 Jan 2016
    This amendment was made to correct several minor errors. The following other important changes were made: - It was specified that Synacthen® was provided to the sites in Poland and Romania. - It was specified that cortisol was to be measured at SV2 and Week 4.
    14 Mar 2016
    This amendment was made to correct some minor errors.
    29 Aug 2016
    This amendment was made to correct an error, namely that serum cortisol analysis was mandated for all subjects. This measurement was only required for subjects in the HPA axis cohort. The following other important changes were made: - A separate schedule of trial procedures was added for subjects in the non-HPA axis cohort. - It was specified that LEO 90100 has different storage conditions in EU and the US (according to approved label).

    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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