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    Clinical Trial Results:
    Double-blind, randomised clinical study comparing efficacy and safety of Clindamycin/Benzoyl Peroxide Gel (10 mg/g + 50 mg/g) (Test) vs. DUAC Akne Gel (Reference) vs. Vehicle in patients with papulopustular acne

    Summary
    EudraCT number
    		 2017-000522-36
    Trial protocol
    		 DE  
    Global end of trial date
    02 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2022
    First version publication date
    18 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    17-02/ClinBPO-50
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dermapharm AG
    Sponsor organisation address
    Lil-Dagover-Ring 7, Gruenwald, Germany, 82031
    Public contact
    Clinical Research Department, Dermapharm AG, +49 89641860, Clinicaltrials.Dermapharm@dermapharm.com
    Scientific contact
    Clinical Research Department, Dermapharm AG, +49 89641860, Clinicaltrials.Dermapharm@dermapharm.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
    07 Dec 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jun 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the efficacy and safety of a new gel containing 10 mg/g Clindamycin and 50 mg/g Benzoyl peroxide vs. DUAC Akne Gel (Reference) vs. vehicle in patients with papulopustular acne
    Protection of trial subjects
    In the current clinical trial patients below the age of 18 have been included. In such a case, an age-appropriate written subject information sheet was handed over to adolescent patients and an appropriate information session was to be performed by the investigator. The legal guardian(s) received a comparable document and an information session for adults. Before the start of screening and randomisation for the current clinical trial, the legal guardian(s) had to sign the informed consent form(s) and the adolescent patient the informed assent form. In case any of the parties (legal guardian(s) or adolescent patient) refused their consent, a participation of the adolescent patient in the trial was not possible.
    Background therapy
    		 There was no background therapy.
    Evidence for comparator
    		 The comparator contains the same ingredients in the same concentration as the test product and has a marketing license for the study indication.
    Actual start date of recruitment
    22 Aug 2018
    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: 674
    Worldwide total number of subjects
    674
    EEA total number of subjects
    674
    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)
    282
    Adults (18-64 years)
    392
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 18 study centers in Germany; first patient first visit: 17 September 2018; last patient last visit: 02 June 2021

    Pre-assignment
    Screening details
    		 Main criteria for inclusion: Women, men and adolescents of ≥ 12 years of age; Diagnosis of “papulopustular acne” according to generally accepted criteria; On the face, ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions, thereof ≤ 2 nodular lesions; Investigator`s Global Assessment (IGA) of acne severity grade 2, 3 or 4

    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, Monitor, Data analyst
    Blinding implementation details
    The tubes containing the study medications were neutral white. The attached labels were identical for all three preparations. All three study medications were indistinguishable with respect to visual or odorous characteristics. The random code was transferred to the data base not before the following actions were completed: data base closure, finalisation of the statistical analysis plan, a Blind Data Review and a subsequent Blind Data Report.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ClinBPO 50
    Arm description
    		 Test product
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clindamycin/Benzoyl Peroxide Gel (10 mg/g + 50 mg/g)
    Investigational medicinal product code
    D10AF51
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The study medication had to be applied to the washed treatment area, i.e. acne affected area on the face, once daily in the evening. The gel should be applied in such a thin film that the gel rubs easily into the skin. Face was considered as the area bounded by ears, hairline and lower margin of the mandibles. Contact with mouth, eyes, lips, other mucous membranes, or areas of irritated or broken skin should be avoided.

    Arm title
    		 DUAC Akne
    Arm description
    		 Reference Product
    Arm type
    		 Active comparator

    Investigational medicinal product name
    DUAC Akne Gel
    Investigational medicinal product code
    D10AF51
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The study medication had to be applied to the washed treatment area, i.e. acne affected area on the face, once daily in the evening. The gel should be applied in such a thin film that the gel rubs easily into the skin. Face was considered as the area bounded by ears, hairline and lower margin of the mandibles. Contact with mouth, eyes, lips, other mucous membranes, or areas of irritated or broken skin should be avoided.

    Arm title
    		 Vehicle
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    D10AF51
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The study medication had to be applied to the washed treatment area, i.e. acne affected area on the face, once daily in the evening. The gel should be applied in such a thin film that the gel rubs easily into the skin. Face was considered as the area bounded by ears, hairline and lower margin of the mandibles. Contact with mouth, eyes, lips, other mucous membranes, or areas of irritated or broken skin should be avoided.

    Number of subjects in period 1
    		ClinBPO 50 DUAC Akne Vehicle
    Started
    223
    224
    227
    Completed
    208
    203
    195
    Not completed
    15
    21
    32
         Consent withdrawn by subject
    4
    3
    1
         Adverse event, non-fatal
    1
    4
    3
         Poor compliance
    1
    2
    3
         COVID-19 related
    1
    -
    -
         Lost to follow-up
    4
    9
    6
         Lack of efficacy
    4
    3
    19

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Period Total
    Number of subjects
    		 674 674
    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)
    		 282 282
        Adults (18-64 years)
    		 392 392
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 442 442
        Male
    		 232 232
    Subject analysis sets

    Subject analysis set title
    Safety data set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Comprises all randomised patients who had administered the study medication at least once and who provided at least one safety related outcome.

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Consists of all patients as randomised who received study medication at least once and have a baseline assessment and at least one post-baseline assessment of the number of papulopustular acne lesions.

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Comprises all patients of the FAS who do not exhibit any major protocol violations.

    Subject analysis sets values
    		 Safety data set FAS PP
    Number of subjects
    674
    672
    597
    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)
    282
    281
    262
        Adults (18-64 years)
    392
    391
    335
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    442
    441
    381
        Male
    232
    231
    216

    End points

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    End points reporting groups
    Reporting group title
    ClinBPO 50
    Reporting group description
    		 Test product

    Reporting group title
    DUAC Akne
    Reporting group description
    		 Reference Product

    Reporting group title
    Vehicle
    Reporting group description
    		 -

    Subject analysis set title
    Safety data set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Comprises all randomised patients who had administered the study medication at least once and who provided at least one safety related outcome.

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Consists of all patients as randomised who received study medication at least once and have a baseline assessment and at least one post-baseline assessment of the number of papulopustular acne lesions.

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Comprises all patients of the FAS who do not exhibit any major protocol violations.

    Primary: Treatment effect (inflammatory lesions)

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    End point title
    		 Treatment effect (inflammatory lesions)
    End point description
    End point type
    Primary
    End point timeframe
    Treatment start (Visit 1) to end-of-treatment (EOT) examination at Visit V8 (week 12).
    End point values
    		 ClinBPO 50 DUAC Akne Vehicle
    Number of subjects analysed
    199
    195
    227
    Units: percent change
        arithmetic mean (standard deviation)
    84.6 ± 22.43
    81.8 ± 25.42
    50.7 ± 41.61
    Statistical analysis title
    		 Analysis of efficacy
    Statistical analysis description
    The first part of the primary objective of this study was to show therapeutic equivalence of the test preparation ClinBPO 50 as compared to the reference DUAC Akne. Therapeutic equivalence was statistically proven if the two-sided 95% confidence interval (CI) for μ INFL-ClinBPO 50 - μ INFL-DUAC Akne was completely contained within [-10.0, 10.0].
    Comparison groups
    ClinBPO 50 v DUAC Akne
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.95
         upper limit
    		 7.54
    Statistical analysis title
    		 Superiority of Test over Vehicle
    Statistical analysis description
    In order to verify assay sensitivity of the study design, superiority of the two active preparations over vehicle was tested by means of two-sided significance tests with α = 0.05. The primary test of superiority was carried out for the FAS data set.
    Comparison groups
    ClinBPO 50 v Vehicle
    Number of subjects included in analysis
    426
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Superiority of Reference over Vehicle
    Statistical analysis description
    In order to verify assay sensitivity of the study design, superiority of the two active preparations over vehicle was tested by means of two-sided significance tests with α = 0.05. The primary test of superiority was carried out for the FAS data set.
    Comparison groups
    DUAC Akne v Vehicle
    Number of subjects included in analysis
    422
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Treatment effect (total number of lesions)

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    End point title
    		 Treatment effect (total number of lesions)
    End point description
    End point type
    Primary
    End point timeframe
    s. Timeframe "Treatment effect (inflammatory lesions)"
    End point values
    		 ClinBPO 50 DUAC Akne Vehicle
    Number of subjects analysed
    199
    195
    227
    Units: percent change
        arithmetic mean (standard deviation)
    80.2 ± 22.64
    77.3 ± 24.30
    49.1 ± 35.03
    Statistical analysis title
    		 Analysis of efficacy
    Statistical analysis description
    The first part of the primary objective of this study was to show therapeutic equivalence of the test preparation ClinBPO 50 as compared to the reference DUAC Akne. Therapeutic equivalence was statistically proven if the two-sided 95% confidence interval (CI) for μ TOTAL-ClinBPO 50 - μ TOTAL-DUAC Akne was completely contained within [-10.0, 10.0].
    Comparison groups
    ClinBPO 50 v DUAC Akne
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.79
         upper limit
    		 7.51
    Statistical analysis title
    		 Superiority of Test over Vehicle
    Statistical analysis description
    In order to verify assay sensitivity of the study design, superiority of the two active preparations over vehicle was tested by means of two-sided significance tests with α = 0.05. The primary test of superiority was carried out for the FAS data set.
    Comparison groups
    ClinBPO 50 v Vehicle
    Number of subjects included in analysis
    426
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Superiority of Reference over Vehicle
    Statistical analysis description
    In order to verify assay sensitivity of the study design, superiority of the two active preparations over vehicle was tested by means of two-sided significance tests with α = 0.05. The primary test of superiority was carried out for the FAS data set.
    Comparison groups
    DUAC Akne v Vehicle
    Number of subjects included in analysis
    422
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From inclusion visit (day 0, Visit V1) to end-of-treatment (EOT) examination at Visit V8 (week 12).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    ClinBPO 50
    Reporting group description
    		 Test product

    Reporting group title
    DUAC Akne
    Reporting group description
    		 Reference Product

    Reporting group title
    Vehicle
    Reporting group description
    		 -

    Serious adverse events
    		 ClinBPO 50 DUAC Akne Vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 222 (0.45%)
    1 / 224 (0.45%)
    1 / 228 (0.44%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Burns second degree
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vestibular disorder
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 ClinBPO 50 DUAC Akne Vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    108 / 222 (48.65%)
    111 / 224 (49.55%)
    79 / 228 (34.65%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Fibrous histiocytoma
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Skin papilloma
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Surgical and medical procedures
    Dental operation
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Limb operation
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Wisdom teeth removal
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Application site dryness
         subjects affected / exposed
    16 / 222 (7.21%)
    16 / 224 (7.14%)
    12 / 228 (5.26%)
         occurrences all number
    16
    16
    12
    Application site erythema
         subjects affected / exposed
    7 / 222 (3.15%)
    5 / 224 (2.23%)
    1 / 228 (0.44%)
         occurrences all number
    7
    6
    1
    Application site exfoliation
         subjects affected / exposed
    5 / 222 (2.25%)
    3 / 224 (1.34%)
    0 / 228 (0.00%)
         occurrences all number
    5
    3
    0
    Application site irritation
         subjects affected / exposed
    0 / 222 (0.00%)
    3 / 224 (1.34%)
    0 / 228 (0.00%)
         occurrences all number
    0
    3
    0
    Application site pain
         subjects affected / exposed
    3 / 222 (1.35%)
    4 / 224 (1.79%)
    1 / 228 (0.44%)
         occurrences all number
    4
    4
    1
    Application site pruritus
         subjects affected / exposed
    2 / 222 (0.90%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    2
    1
    0
    Application site reaction
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Application site swelling
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Inflammation
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    1
    0
    1
    Pyrexia
         subjects affected / exposed
    3 / 222 (1.35%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    3
    1
    0
    Immune system disorders
    Allergy to metals
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Atopy
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Food allergy
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Hypersensitivity
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 222 (0.90%)
    4 / 224 (1.79%)
    0 / 228 (0.00%)
         occurrences all number
    3
    4
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 222 (0.90%)
    1 / 224 (0.45%)
    3 / 228 (1.32%)
         occurrences all number
    2
    1
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Attention deficit hyperactivity disorder
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Arthroscopy
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Vitamin D decreased
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Contusion
         subjects affected / exposed
    2 / 222 (0.90%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    2
    0
    0
    Foreign body in eye
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Hand fracture
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Ligament rupture
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Product administered at inappropriate site
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Scar
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Skin laceration
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Congenital, familial and genetic disorders
    Dermoid cyst
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    16 / 222 (7.21%)
    22 / 224 (9.82%)
    6 / 228 (2.63%)
         occurrences all number
    19
    24
    6
    Headache
         subjects affected / exposed
    12 / 222 (5.41%)
    3 / 224 (1.34%)
    11 / 228 (4.82%)
         occurrences all number
    13
    4
    13
    Migraine
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Motion sickness
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Eye disorders
    Eye swelling
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Lacrimation increased
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Swelling of eyelid
         subjects affected / exposed
    0 / 222 (0.00%)
    2 / 224 (0.89%)
    0 / 228 (0.00%)
         occurrences all number
    0
    2
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 222 (0.45%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    2
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    1 / 228 (0.44%)
         occurrences all number
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    3 / 222 (1.35%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    3
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    2 / 222 (0.90%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    2
    0
    0
    Toothache
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    5 / 228 (2.19%)
         occurrences all number
    0
    1
    5
    Alopecia areata
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Dermal cyst
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Dermatitis contact
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    2 / 228 (0.88%)
         occurrences all number
    0
    0
    2
    Dry skin
         subjects affected / exposed
    14 / 222 (6.31%)
    21 / 224 (9.38%)
    2 / 228 (0.88%)
         occurrences all number
    16
    23
    3
    Dyshidrotic eczema
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    2
    0
    0
    Eczema
         subjects affected / exposed
    1 / 222 (0.45%)
    1 / 224 (0.45%)
    1 / 228 (0.44%)
         occurrences all number
    1
    1
    1
    Eczema asteatotic
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Erythema
         subjects affected / exposed
    15 / 222 (6.76%)
    18 / 224 (8.04%)
    5 / 228 (2.19%)
         occurrences all number
    16
    18
    5
    Hand dermatitis
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    1
    0
    1
    Keloid scar
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Mechanical urticaria
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Papule
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus
         subjects affected / exposed
    9 / 222 (4.05%)
    14 / 224 (6.25%)
    2 / 228 (0.88%)
         occurrences all number
    11
    14
    2
    Rash
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Skin burning sensation
         subjects affected / exposed
    1 / 222 (0.45%)
    2 / 224 (0.89%)
    1 / 228 (0.44%)
         occurrences all number
    1
    2
    1
    Skin exfoliation
         subjects affected / exposed
    8 / 222 (3.60%)
    12 / 224 (5.36%)
    5 / 228 (2.19%)
         occurrences all number
    8
    14
    5
    Skin irritation
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Skin tightness
         subjects affected / exposed
    2 / 222 (0.90%)
    5 / 224 (2.23%)
    3 / 228 (1.32%)
         occurrences all number
    2
    5
    3
    Solar dermatitis
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    1 / 228 (0.44%)
         occurrences all number
    0
    1
    1
    Renal and urinary disorders
    Urinary tract pain
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 222 (0.00%)
    2 / 224 (0.89%)
    1 / 228 (0.44%)
         occurrences all number
    0
    2
    1
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Acarodermatitis
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    2
    0
    1
    Bronchitis
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    COVID-19
         subjects affected / exposed
    0 / 222 (0.00%)
    2 / 224 (0.89%)
    0 / 228 (0.00%)
         occurrences all number
    0
    2
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    1 / 228 (0.44%)
         occurrences all number
    0
    1
    1
    Cystitis
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Cystitis bacterial
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Fungal skin infection
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 222 (0.90%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    2
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    2 / 222 (0.90%)
    1 / 224 (0.45%)
    1 / 228 (0.44%)
         occurrences all number
    2
    1
    1
    Herpes simplex
         subjects affected / exposed
    1 / 222 (0.45%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    1
    1
    0
    Hordeolum
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    1
    0
    1
    Infection
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Influenza
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Laryngitis
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    23 / 222 (10.36%)
    25 / 224 (11.16%)
    15 / 228 (6.58%)
         occurrences all number
    25
    30
    16
    Oral herpes
         subjects affected / exposed
    1 / 222 (0.45%)
    1 / 224 (0.45%)
    2 / 228 (0.88%)
         occurrences all number
    1
    1
    2
    Otitis media
         subjects affected / exposed
    2 / 222 (0.90%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    2
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 222 (0.45%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    1
    1
    0
    Pyelitis
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 222 (0.45%)
    1 / 224 (0.45%)
    1 / 228 (0.44%)
         occurrences all number
    1
    1
    1
    Rhinitis
         subjects affected / exposed
    2 / 222 (0.90%)
    2 / 224 (0.89%)
    0 / 228 (0.00%)
         occurrences all number
    2
    2
    0
    Tinea pedis
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    2 / 222 (0.90%)
    2 / 224 (0.89%)
    0 / 228 (0.00%)
         occurrences all number
    2
    3
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Arthralgia
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0

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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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