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    Clinical Trial Results:
    Double-blind, randomised clinical study comparing efficacy and safety of Clindamycin/Benzoyl Peroxide Gel (10 mg/g + 30 mg/g) (Test) vs. DUAC 10 mg/g + 30 mg/g Gel (Reference) vs. Vehicle in patients with papulopustular acne

    Summary
    EudraCT number
    		 2017-000521-13
    Trial protocol
    		 CZ  
    Global end of trial date
    01 Mar 2021

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

    Trial information

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    Trial identification
    Sponsor protocol code
    17-01/ClinBPO-30
    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
    21 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 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 30 mg/g Benzoyl peroxide vs. DUAC 10 mg/g + 30 mg/g 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
    03 Apr 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czechia: 676
    Worldwide total number of subjects
    676
    EEA total number of subjects
    676
    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)
    378
    Adults (18-64 years)
    298
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 16 study centers in Czechia; first patient first visit: 25 April 2019; last patient last visit: 01 March 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 30
    Arm description
    		 Test product
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clindamycin/Benzoyl Peroxide Gel (10 mg/g + 30 mg/g)
    Investigational medicinal product code
    D10AF51
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    A thin layer of gel should be applied to the affected area once a day. The treatment area was defined as the acne affected areas on the face whereas face was considered as the area bounded by ears, hairline and lower margin of the mandibles. Contact with the mouth, eyes, lips, other mucous membranes or areas of irritated or broken skin should be avoided.

    Arm title
    		 Duac (10 mg/g + 30 mg/g)
    Arm description
    		 Reference Product
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Duac (10 mg/g + 30 mg/g)
    Investigational medicinal product code
    D10AF51
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    A thin layer of gel should be applied to the affected area once a day. The treatment area was defined as the acne affected areas on the face whereas face was considered as the area bounded by ears, hairline and lower margin of the mandibles. Contact with the 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
    A thin layer of gel should be applied to the affected area once a day. The treatment area was defined as the acne affected areas on the face whereas face was considered as the area bounded by ears, hairline and lower margin of the mandibles. Contact with the mouth, eyes, lips, other mucous membranes or areas of irritated or broken skin should be avoided.

    Number of subjects in period 1
    		ClinBPO 30 Duac (10 mg/g + 30 mg/g) Vehicle
    Started
    223
    225
    228
    Completed
    211
    213
    199
    Not completed
    12
    12
    29
         Consent withdrawn by subject
    1
    3
    1
         Poor tolerability (patient)
    3
    1
    1
         Adverse event, non-fatal
    2
    2
    2
         Technical-logistic reasons
    2
    -
    -
         COVID-19 related
    1
    -
    2
         Lost to follow-up
    1
    -
    1
         Lack of efficacy
    2
    6
    22

    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
    		 676 676
    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)
    		 378 378
        Adults (18-64 years)
    		 298 298
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 437 437
        Male
    		 239 239
    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
    676
    673
    628
    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)
    378
    377
    364
        Adults (18-64 years)
    298
    296
    264
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    437
    435
    394
        Male
    239
    238
    234

    End points

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    End points reporting groups
    Reporting group title
    ClinBPO 30
    Reporting group description
    		 Test product

    Reporting group title
    Duac (10 mg/g + 30 mg/g)
    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 V1) to end-of-treatment (EOT) examination at Visit V8 (week 12).
    End point values
    		 ClinBPO 30 Duac (10 mg/g + 30 mg/g) Vehicle
    Number of subjects analysed
    207
    213
    227
    Units: percent change
        arithmetic mean (standard deviation)
    82.7 ± 24.21
    83.7 ± 20.86
    51.5 ± 41.57
    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 30 as compared to the reference DUAC. Therapeutic equivalence was statistically proven if the two-sided 95% confidence interval (CI) for μ INFL-ClinBPO - μ INFL-DUAC was completely contained within [-10.0, 10.0].
    Comparison groups
    ClinBPO 30 v Duac (10 mg/g + 30 mg/g)
    Number of subjects included in analysis
    420
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.38
         upper limit
    		 3.3
    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 ITT data set.
    Comparison groups
    ClinBPO 30 v Vehicle
    Number of subjects included in analysis
    434
    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 ITT data set.
    Comparison groups
    Vehicle v Duac (10 mg/g + 30 mg/g)
    Number of subjects included in analysis
    440
    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
    Treatment start (Visit V1) to end-of-treatment (EOT) examination at Visit V8 (week 12).
    End point values
    		 ClinBPO 30 Duac (10 mg/g + 30 mg/g) Vehicle
    Number of subjects analysed
    207
    213
    227
    Units: percentage change
        arithmetic mean (standard deviation)
    75.1 ± 23.27
    75.9 ± 22.55
    43.7 ± 36.84
    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 30 as compared to the reference DUAC. Therapeutic equivalence was statistically proven if the two-sided 95% confidence interval (CI) for μ TOTAL-ClinBPO - μ TOTAL-DUAC was completely contained within [-10.0, 10.0].
    Comparison groups
    ClinBPO 30 v Duac (10 mg/g + 30 mg/g)
    Number of subjects included in analysis
    420
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.23
         upper limit
    		 3.56
    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 ITT data set.
    Comparison groups
    ClinBPO 30 v Vehicle
    Number of subjects included in analysis
    434
    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 ITT data set.
    Comparison groups
    Vehicle v Duac (10 mg/g + 30 mg/g)
    Number of subjects included in analysis
    440
    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 30
    Reporting group description
    		 Test product

    Reporting group title
    Duac (10 mg/g + 30 mg/g)
    Reporting group description
    		 Reference Product

    Reporting group title
    Vehicle
    Reporting group description
    		 -

    Serious adverse events
    		 ClinBPO 30 Duac (10 mg/g + 30 mg/g) Vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Complicated appendicitis
         subjects affected / exposed
    0 / 223 (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
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 ClinBPO 30 Duac (10 mg/g + 30 mg/g) Vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    55 / 223 (24.66%)
    62 / 224 (27.68%)
    46 / 228 (20.18%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastroenteropancreatic neuroendocrine tumour disease
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Melanocytic naevus
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Skin papilloma
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Application site dermatitis
         subjects affected / exposed
    2 / 223 (0.90%)
    1 / 224 (0.45%)
    1 / 228 (0.44%)
         occurrences all number
    2
    1
    1
    Application site dryness
         subjects affected / exposed
    12 / 223 (5.38%)
    15 / 224 (6.70%)
    5 / 228 (2.19%)
         occurrences all number
    12
    15
    5
    Application site erythema
         subjects affected / exposed
    9 / 223 (4.04%)
    9 / 224 (4.02%)
    4 / 228 (1.75%)
         occurrences all number
    9
    9
    4
    Application site exfoliation
         subjects affected / exposed
    3 / 223 (1.35%)
    2 / 224 (0.89%)
    0 / 228 (0.00%)
         occurrences all number
    3
    2
    0
    Application site hypersensitivity
         subjects affected / exposed
    2 / 223 (0.90%)
    3 / 224 (1.34%)
    1 / 228 (0.44%)
         occurrences all number
    2
    3
    1
    Application site irritation
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Application site pain
         subjects affected / exposed
    6 / 223 (2.69%)
    7 / 224 (3.13%)
    6 / 228 (2.63%)
         occurrences all number
    6
    7
    6
    Application site plaque
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Application site pruritus
         subjects affected / exposed
    2 / 223 (0.90%)
    3 / 224 (1.34%)
    1 / 228 (0.44%)
         occurrences all number
    3
    3
    1
    Application site scab
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 223 (0.45%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    1
    1
    0
    Immune system disorders
    Milk allergy
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 224 (0.00%)
    2 / 228 (0.88%)
         occurrences all number
    1
    0
    2
    Polycystic ovaries
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 223 (2.24%)
    2 / 224 (0.89%)
    1 / 228 (0.44%)
         occurrences all number
    5
    2
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Arthroscopy
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Joint injury
         subjects affected / exposed
    1 / 223 (0.45%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    1
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 223 (1.35%)
    3 / 224 (1.34%)
    2 / 228 (0.88%)
         occurrences all number
    4
    4
    2
    Migraine
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 223 (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
    1 / 223 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    1
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Lip dry
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth malformation
         subjects affected / exposed
    1 / 223 (0.45%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    1
    1
    0
    Toothache
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 223 (0.45%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    1
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 223 (0.45%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    1
    1
    0
    Erythema
         subjects affected / exposed
    3 / 223 (1.35%)
    1 / 224 (0.45%)
    1 / 228 (0.44%)
         occurrences all number
    3
    1
    1
    Hand dermatitis
         subjects affected / exposed
    2 / 223 (0.90%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    2
    0
    0
    Perioral dermatitis
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Photosensitivity reaction
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Solar dermatitis
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Urinary tract discomfort
         subjects affected / exposed
    0 / 223 (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 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Body tinea
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 223 (0.00%)
    3 / 224 (1.34%)
    3 / 228 (1.32%)
         occurrences all number
    0
    3
    3
    COVID-19
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    2 / 228 (0.88%)
         occurrences all number
    0
    1
    2
    Cystitis
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 224 (0.00%)
    0 / 228 (0.00%)
         occurrences all number
    1
    0
    0
    Furuncle
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Genital herpes
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    2
    0
    Hordeolum
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Impetigo
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 224 (0.45%)
    0 / 228 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 223 (1.79%)
    3 / 224 (1.34%)
    1 / 228 (0.44%)
         occurrences all number
    4
    3
    1
    Oral herpes
         subjects affected / exposed
    2 / 223 (0.90%)
    1 / 224 (0.45%)
    1 / 228 (0.44%)
         occurrences all number
    3
    1
    1
    Pharyngitis
         subjects affected / exposed
    1 / 223 (0.45%)
    1 / 224 (0.45%)
    1 / 228 (0.44%)
         occurrences all number
    1
    1
    1
    Pulpitis dental
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 224 (0.00%)
    1 / 228 (0.44%)
         occurrences all number
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    2 / 223 (0.90%)
    1 / 224 (0.45%)
    2 / 228 (0.88%)
         occurrences all number
    2
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 223 (1.35%)
    5 / 224 (2.23%)
    6 / 228 (2.63%)
         occurrences all number
    5
    5
    7
    Urinary tract infection
         subjects affected / exposed
    0 / 223 (0.00%)
    2 / 224 (0.89%)
    0 / 228 (0.00%)
         occurrences all number
    0
    2
    0
    Viral infection
         subjects affected / exposed
    2 / 223 (0.90%)
    1 / 224 (0.45%)
    1 / 228 (0.44%)
         occurrences all number
    3
    1
    1

    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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