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    Clinical Trial Results:
    Assessment of the efficacy of a new formulation of minoxidil (DC120) on hair growth, in a minizone model in androgenetic alopecia in men

    Summary
    EudraCT number
    		 2014-005573-36
    Trial protocol
    		 DE  
    Global end of trial date
    28 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2018
    First version publication date
    16 Dec 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DC0120LE202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pierre Fabre
    Sponsor organisation address
    45 place Abel Gance, Boulogne, France, 92654
    Public contact
    Françoise TONNER, Pierre Fabre Dermatologie represented by the Institut de Recherche Pierre Fabre (IRPF), +33 (0)534 50 62 50, francoise.tonner@pierre-fabre.com
    Scientific contact
    Françoise TONNER, Pierre Fabre Dermatologie represented by the Institut de Recherche Pierre Fabre (IRPF), +33 (0)534 50 62 50, francoise.tonner@pierre-fabre.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
    05 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to demonstrate the non-inferiority of DC0120 (Minoxidil 5%) cutaneous solution on hair growth, versus a reference product (ALOSTIL®; 5% cutaneous solution) in the treatment of Androgenetic Alopecia (AGA), over 16 weeks.
    Protection of trial subjects
    The study was performed in accordance with the current version of the Declaration of Helsinki (1964 andits subsequent amendments). The study was conducted in agreement with the International Conferenceon Harmonisation (ICH) guidelines on Good Clinical Practice (GCP), and with related national regulation in biomedical research. The first study protocol in use (V2, 28 May 2015), and the patient information sheets were reviewed and approved by the BfArM. There were no substantial subsequent amendments. Patients were free to withdraw from the study at any time for any reason. The investigator could decide to withdraw a patient from the study due to tolerability/safety/efficacy issues if it was felt to be in the patient’s best interests
    Background therapy
    		 No additional therapy was given during the study.
    Evidence for comparator
    		 ALOPEXY® 5% (DC0120) cutaneous solution is a generic of REGAINE® 5% solution already registered in Europe. REGAINE® has been marketed in several European countries for many years, and is also registered and marketed in France since 1995, under the trade name of ALOSTIL® 5%. The composition of ALOPEXY® 5% cutaneous solution is similar to that of the reference product. In compliance with the ICH Guidelines (E9-Feb 1998) placebo was to be added in this design in order to test the assay sensitivity by confirming the efficacy of the active reference versus placebo in the current trial. As the 2 formulations had a different appearance, a double placebo design had to be used.
    Actual start date of recruitment
    01 Jun 2015
    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: 220
    Worldwide total number of subjects
    220
    EEA total number of subjects
    220
    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)
    220
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 231 patients were screened and 220 met the inclusion criteria and were randomised as planned to one of the 4 combination group, in 4 investigational centres in Germany. There were 11 screen failures: 7 patients were not pre-included (they did not meet all eligibility criteria or they decided not to participate), and 4 were not randomised

    Pre-assignment
    Screening details
    		 Male subjects aged 18-65 years suffering from frontoemporal androgenetic alopecia, accepting to have 2 shaved and tattooed minizones on the scalp, with no historical of skin scalp abnormalities with a potential impact on the treatment response. The patients with a phototype > IV were not included in the study.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor
    Blinding implementation details
    As the ALOSTIL® marketed form was the reference product in the study, a double placebo was used in order to obtain the double blind conditions, ensured by:  similar solutions for cutaneous application in 60 mL-bottles of DC0120 (minoxidil 5%) and placebo of DC0120;  similar solutions for cutaneous application in 60 mL-bottles of the marketed solution ALOSTIL® and its placebo. Patients were provided wtih 1 blue case of treatment for the left side and one red case for the right side

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DC120-Placebo of Alostil
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo of Alostil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    0.1 mL (for approximately 10 cm²), 2 applications per day (morning and evening; at least 8 hours apart) on one randomised test area. Cutaneous applications performed with a 0.6 mL single-use dose dispensing syringe and gentle massage, according to the randomisation scheme on 1 of the 2 target zones (about 10 cm2) on the frontal area of the scalp. The application side of the 2 study treatments was randomised.

    Investigational medicinal product name
    DC0120 (Minoxidil 5%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    0.1 mL (for approximately 10 cm²), 2 applications per day (morning and evening; at least 8 hours apart) on one randomised test area. Cutaneous applications performed with a 0.6 mL single-use dose dispensing syringe and gentle massage, according to the randomisation scheme on 1 of the 2 target zones (about 10 cm2) on the frontal area of the scalp. The application side of the 2 study treatments was randomised.

    Arm title
    		 DC0120-Alostil
    Arm description
    		 All patients applied for 16 weeks (Day 1 [V2] to Day 110 ± 3 days [V9]) minoxidil 5% ( DC0120) solution and Alostil solution (one product on each side). The study product DC0120, the reference product ALOSTIL® and the corresponding placebos were randomised between 2 contra-lateral zones, the right and left sides of the frontal areas of the scalp using an incomplete block design. For training purposes, the patient applied the products the first day and 2 more days after within the 5 days after the first application at the Investigational Centre (in the morning or at the end of afternoon) under supervision of a trained person different from the investigator.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DC0120 (Minoxidil 5%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    0.1 mL (for approximately 10 cm²), 2 applications per day (morning and evening; at least 8 hours apart) on one randomised test area. Cutaneous applications performed with a 0.6 mL single-use dose dispensing syringe and gentle massage, according to the randomisation scheme on 1 of the 2 target zones (about 10 cm2) on the frontal area of the scalp. The application side of the 2 study treatments was randomised.

    Investigational medicinal product name
    Alostil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    0.1 mL (for approximately 10 cm²), 2 applications per day (morning and evening; at least 8 hours apart) on one randomised test area. Cutaneous applications performed with a 0.6 mL single-use dose dispensing syringe and gentle massage, according to the randomisation scheme on 1 of the 2 target zones (about 10 cm2) on the frontal area of the scalp. The application side of the 2 study treatments was randomised.

    Arm title
    		 Alostil-placebo DC120
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alostil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    0.1 mL (for approximately 10 cm²), 2 applications per day (morning and evening; at least 8 hours apart) on one randomised test area. Cutaneous applications performed with a 0.6 mL single-use dose dispensing syringe and gentle massage, according to the randomisation scheme on 1 of the 2 target zones (about 10 cm2) on the frontal area of the scalp. The application side of the 2 study treatments was randomised.

    Investigational medicinal product name
    Placebo DC0120
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    0.1 mL (for approximately 10 cm²), 2 applications per day (morning and evening; at least 8 hours apart) on one randomised test area. Cutaneous applications performed with a 0.6 mL single-use dose dispensing syringe and gentle massage, according to the randomisation scheme on 1 of the 2 target zones (about 10 cm2) on the frontal area of the scalp. The application side of the 2 study treatments was randomised.

    Arm title
    		 placebo DC0120-placebo Alostil
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo DC0120
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    0.1 mL (for approximately 10 cm²), 2 applications per day (morning and evening; at least 8 hours apart) on one randomised test area. Cutaneous applications performed with a 0.6 mL single-use dose dispensing syringe and gentle massage, according to the randomisation scheme on 1 of the 2 target zones (about 10 cm2) on the frontal area of the scalp. The application side of the 2 study treatments was randomised.

    Investigational medicinal product name
    Placebo of Alostil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    0.1 mL (for approximately 10 cm²), 2 applications per day (morning and evening; at least 8 hours apart) on one randomised test area. Cutaneous applications performed with a 0.6 mL single-use dose dispensing syringe and gentle massage, according to the randomisation scheme on 1 of the 2 target zones (about 10 cm2) on the frontal area of the scalp. The application side of the 2 study treatments was randomised.

    Number of subjects in period 1
    		DC120-Placebo of Alostil DC0120-Alostil Alostil-placebo DC120 placebo DC0120-placebo Alostil
    Started
    44
    110
    44
    22
    Completed
    42
    104
    42
    22
    Not completed
    2
    6
    2
    0
         Consent withdrawn by subject
    -
    -
    1
    -
         Adverse event, non-fatal
    1
    3
    -
    -
         Personal reason
    1
    3
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DC120-Placebo of Alostil
    Reporting group description
    		 -

    Reporting group title
    DC0120-Alostil
    Reporting group description
    		 All patients applied for 16 weeks (Day 1 [V2] to Day 110 ± 3 days [V9]) minoxidil 5% ( DC0120) solution and Alostil solution (one product on each side). The study product DC0120, the reference product ALOSTIL® and the corresponding placebos were randomised between 2 contra-lateral zones, the right and left sides of the frontal areas of the scalp using an incomplete block design. For training purposes, the patient applied the products the first day and 2 more days after within the 5 days after the first application at the Investigational Centre (in the morning or at the end of afternoon) under supervision of a trained person different from the investigator.

    Reporting group title
    Alostil-placebo DC120
    Reporting group description
    		 -

    Reporting group title
    placebo DC0120-placebo Alostil
    Reporting group description
    		 -

    Reporting group values
    		 DC120-Placebo of Alostil DC0120-Alostil Alostil-placebo DC120 placebo DC0120-placebo Alostil Total
    Number of subjects
    		 44 110 44 22 220
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 44 110 44 22 220
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 41.0 (19.0 to 62.0) 44.0 (31.0 to 51.0) 39.5 (31.0 to 45.0) 38.0 (32.0 to 51.0) -
    Gender categorical
    Units: Subjects
        Male
    		 44 110 44 22 220
    Nordwood Hamilton Scale
    Units: Subjects
        03
    		 12 36 10 4 62
        03A
    		 4 10 7 1 22
        03V
    		 15 40 16 8 79
        04
    		 13 23 10 8 54
        04A
    		 0 1 1 1 3
    Smoker status
    Units: Subjects
        No smoker
    		 29 73 33 14 149
        Smoker
    		 15 37 11 8 71
    Fitzpatricks Classification
    Units: Subjects
        01
    		 1 0 1 0 2
        02
    		 20 36 15 6 77
        03
    		 19 69 25 13 126
        04
    		 4 5 3 3 15
    Subject analysis sets

    Subject analysis set title
    Full analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) is defined as all randomised patients with at least one application of a treatment.

    Subject analysis sets values
    		 Full analysis Set
    Number of subjects
    220
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    220
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    42.0 (32.0 to 50.0)
    Gender categorical
    Units: Subjects
        Male
    220
    Nordwood Hamilton Scale
    Units: Subjects
        03
    62
        03A
    22
        03V
    79
        04
    54
        04A
    3
    Smoker status
    Units: Subjects
        No smoker
    149
        Smoker
    71
    Fitzpatricks Classification
    Units: Subjects
        01
    2
        02
    77
        03
    126
        04
    15

    End points

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    End points reporting groups
    Reporting group title
    DC120-Placebo of Alostil
    Reporting group description
    		 -

    Reporting group title
    DC0120-Alostil
    Reporting group description
    		 All patients applied for 16 weeks (Day 1 [V2] to Day 110 ± 3 days [V9]) minoxidil 5% ( DC0120) solution and Alostil solution (one product on each side). The study product DC0120, the reference product ALOSTIL® and the corresponding placebos were randomised between 2 contra-lateral zones, the right and left sides of the frontal areas of the scalp using an incomplete block design. For training purposes, the patient applied the products the first day and 2 more days after within the 5 days after the first application at the Investigational Centre (in the morning or at the end of afternoon) under supervision of a trained person different from the investigator.

    Reporting group title
    Alostil-placebo DC120
    Reporting group description
    		 -

    Reporting group title
    placebo DC0120-placebo Alostil
    Reporting group description
    		 -

    Subject analysis set title
    Full analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) is defined as all randomised patients with at least one application of a treatment.

    Primary: Change from baselin of non-vellus Target Area Hair Count (TAHC)

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    End point title
    		 Change from baselin of non-vellus Target Area Hair Count (TAHC) [1]
    End point description
    The primary outcome measure was the change from baseline of nonvellus TAHC (number of hairs with diameter > 30 μm/cm²) measured using the PTG method (Trichoscan®) between V2 (baseline) and V10 (Week 16). The global baseline factor is the mean of the nonvellus TAHC at V2 for each minizone.
    End point type
    Primary
    End point timeframe
    The end point was measured between V2 (baseline) and V10 (Week 16).
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The reporting group Placebo DC0120-Placebo Alostil was not taken into account for the primary endopint because of the use of placebo.
    End point values
    		 DC120-Placebo of Alostil DC0120-Alostil Alostil-placebo DC120
    Number of subjects analysed
    44
    110
    44
    Units: hairs/cm²
        arithmetic mean (standard error)
    21.99 ( 1.97 )
    21.99 ( 1.97 )
    21.99 ( 1.97 )
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    DC120-Placebo of Alostil v DC0120-Alostil v Alostil-placebo DC120
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event were reported at each visit during the study period (from study enrolment visit to study-end visits.
    Adverse event reporting additional description
    At enrolment, any concomitant disease was reported on the CRF. At each further visit, the occurrence of AEs since the last visit was to be determined by the patient’s spontaneous reporting, the investigator’s non-leading questioning and his clinical evaluation (vital signs, physical examination and examination of the scalp).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    DC0120-Alostil
    Reporting group description
    		 -

    Reporting group title
    DC0120-Placebo of Alostil
    Reporting group description
    		 -

    Reporting group title
    Alostil-Placebo of DC0120
    Reporting group description
    		 -

    Reporting group title
    Placebo of DC0120-Placebo of Alostil
    Reporting group description
    		 -

    Serious adverse events
    		 DC0120-Alostil DC0120-Placebo of Alostil Alostil-Placebo of DC0120 Placebo of DC0120-Placebo of Alostil
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (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
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (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: 0.5%
    Non-serious adverse events
    		 DC0120-Alostil DC0120-Placebo of Alostil Alostil-Placebo of DC0120 Placebo of DC0120-Placebo of Alostil
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 110 (32.73%)
    15 / 44 (34.09%)
    10 / 44 (22.73%)
    7 / 22 (31.82%)
    Vascular disorders
    Diastolic hypertension
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Surgical and medical procedures
    Dental care
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Endodontic procedure
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 44 (2.27%)
    1 / 44 (2.27%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Tooth extraction
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tooth repair
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 44 (4.55%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Application site acne
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Application site exfoliation
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Application site pruritus
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 110 (0.00%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Social circumstances
    Blood donor
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 110 (1.82%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Cough
         subjects affected / exposed
    0 / 110 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Accidental exposure to product
         subjects affected / exposed
    0 / 110 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    Contusion
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Excoriation
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Laceration
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ligament sprain
         subjects affected / exposed
    0 / 110 (0.00%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Meniscus injury
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 110 (4.55%)
    3 / 44 (6.82%)
    1 / 44 (2.27%)
    0 / 22 (0.00%)
         occurrences all number
    6
    3
    1
    0
    Orthostatic intolerance
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 110 (0.00%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vertigo
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 44 (2.27%)
    1 / 44 (2.27%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Gastritis
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Dental caries
         subjects affected / exposed
    0 / 110 (0.00%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    6 / 110 (5.45%)
    3 / 44 (6.82%)
    0 / 44 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    6
    3
    0
    1
    Skin exfoliation
         subjects affected / exposed
    0 / 110 (0.00%)
    3 / 44 (6.82%)
    1 / 44 (2.27%)
    1 / 22 (4.55%)
         occurrences all number
    0
    3
    3
    1
    Skin burning sensation
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    2
    0
    0
    1
    Dermatitis contact
         subjects affected / exposed
    1 / 110 (0.91%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Eczema
         subjects affected / exposed
    1 / 110 (0.91%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Erythema
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Eczema asteatotic
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eczema nummular
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 110 (0.00%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypertrichosis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pain of skin
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Tendonitis
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Back pain
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Bursitis
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Myositis
         subjects affected / exposed
    0 / 110 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 110 (11.82%)
    6 / 44 (13.64%)
    7 / 44 (15.91%)
    3 / 22 (13.64%)
         occurrences all number
    18
    6
    7
    4
    Oral herpes
         subjects affected / exposed
    3 / 110 (2.73%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Rash pustular
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    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.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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