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    Clinical Trial Results:
    Efficacy and safety of CD5024 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea over 16 weeks treatment, followed by a 36-week extension period

    These results have been removed from public view whilst they are reviewed and may need to be corrected before being returned to public view
    Summary
    EudraCT number
    		 2011-004791-11
    Trial protocol
    		 CZ   GB   DE   HU   BG  
    Global end of trial date
    19 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Mar 2016
    First version publication date
    16 Mar 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RD.03.SPR.40173CZ
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galderma R&D SNC
    Sponsor organisation address
    Les Templiers, 2400 Route des Colles, BIOT, France,
    Public contact
    CTA Coordinator, Galderma R&D SNC, +33 (0)493-95-70-85, cta.coordinator@galderma.com
    Scientific contact
    CTA Coordinator, Galderma R&D SNC, +33 (0)493-95-70-85, cta.coordinator@galderma.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 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Period A: To compare efficacy and safety of CD5024 1% cream applied once daily versus metronidazole 0.75% cream applied twice daily in subjects with papulopustular rosacea after 16-week topical treatment. Period B: To compare, for subjects initially successfully treated by 16 weeks treatment, CD5024 1% cream versus metronidazole 0.75% cream during a 36-week extension period by assessing: - The time of first relapse, - The relapse rate, - And the number of days free of treatment The safety objective of this study for Period A and Period B was to assess the overall safety of CD5024 1% Cream applied once daily up to 16 weeks during Period A and up to 28 weeks during Period B compared to Metronidazole 0.75% Cream.
    Protection of trial subjects
    Safety was documented by recording AEs, rosacea signs and symptoms, physical examinations, and vital signs and blood hematology and biochemistry on an ongoing basis. Furthermore, an IDMC was established in order to ensure subject safety by reviewing any hematology laboratory results or SAE reports that they received after subject randomization.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Apr 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Romania: 109
    Country: Number of subjects enrolled
    Russian Federation: 74
    Country: Number of subjects enrolled
    Ukraine: 60
    Country: Number of subjects enrolled
    Poland: 114
    Country: Number of subjects enrolled
    United Kingdom: 35
    Country: Number of subjects enrolled
    Bulgaria: 37
    Country: Number of subjects enrolled
    Czech Republic: 80
    Country: Number of subjects enrolled
    France: 67
    Country: Number of subjects enrolled
    Germany: 226
    Country: Number of subjects enrolled
    Hungary: 160
    Worldwide total number of subjects
    962
    EEA total number of subjects
    828
    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)
    792
    From 65 to 84 years
    168
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 1034 subjects were screened in 64 centers in 10 countries (Bulgaria, Czech Republic,France, Germany, Great-Britain, Hungary, Poland, Romania, Russia, and Ukraine), among which 962 were randomized to receive Ivermectin 1% Cream (N=478) or Metronidazole 0.75% Cream (N=484).

    Pre-assignment
    Screening details
    		 In Period A, 962 subjects were randomized to receive Ivermectin 1% Cream (N=478) or Metronidazole 0.75% Cream (N=484) in 64 centers . In total, 762 subjects were eligible for entering in Period B and 757 out of these subjects decided to continue in Period B: 399 subjects in the Ivermectin 1% Cream group and 358 subjects in the Metronidazole 0.75%

    Pre-assignment period milestones
    Number of subjects started
    		 962
    Number of subjects completed
    		 962

    Period 1
    Period 1 title
    Period A
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ivermectin 1% cream
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ivermectin 1% Cream
    Investigational medicinal product code
    CD5024
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    one small pea size applied on right and left cheeks, forehead, chin and nose) at bedtime

    Arm title
    		 Metronidazole 0.75% Cream
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Metronidazole 0.75% Cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Approximately one small pea size amount per facial region (right and left cheeks, forehead, chin and nose). Twice daily at morning and bedtime 7 days a week

    Investigational medicinal product name
    Ivermectin 1% cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Approximately one small pea size amount per facial region (right and left cheeks, forehead, chin and nose) 7 days a week Once daily at bedtime

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Patients not considered blinded as difference in regimen between active controlled arm and CD5024 (BID versus QD)
    Number of subjects in period 1
    		Ivermectin 1% cream Metronidazole 0.75% Cream
    Started
    478
    484
    Completed
    446
    456
    Not completed
    32
    28
         Consent withdrawn by subject
    21
    9
         Adverse event, non-fatal
    6
    13
         Pregnancy
    1
    1
         other
    -
    1
         Lost to follow-up
    3
    2
         Protocol deviation
    1
    2
    Period 2
    Period 2 title
    Period B
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [2]
    Blinding implementation details
    Randomisation was the same as period A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ivermectin 1% cream
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ivermectin 1% Cream
    Investigational medicinal product code
    CD5024
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    one small pea size applied on right and left cheeks, forehead, chin and nose) at bedtime

    Arm title
    		 Metronidazole 0.75% Cream
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ivermectin 1% Cream
    Investigational medicinal product code
    CD5024
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    one small pea size applied on right and left cheeks, forehead, chin and nose) at bedtime

    Investigational medicinal product name
    Ivermectin 1% Cream
    Investigational medicinal product code
    CD5024
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    one small pea size applied on right and left cheeks, forehead, chin and nose) at bedtime

    Investigational medicinal product name
    Metronidazole 0.75% Cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    approximately one small pea size amount per facila region (right and left cheeks, forehead, chin and nose). Twice daily at morning and bedtime. 7 days a week

    Notes
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Patients not considered blinded as difference in regimen between active controlled arm and CD5024 (BID versus QD)
    Number of subjects in period 2 [3]
    		Ivermectin 1% cream Metronidazole 0.75% Cream
    Started
    399
    358
    Completed
    366
    326
    Not completed
    33
    32
         Consent withdrawn by subject
    23
    18
         Adverse event, non-fatal
    2
    4
         Pregnancy
    2
    1
         other
    2
    2
         Lost to follow-up
    2
    4
         Protocol deviation
    2
    3
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: In total, 762 subjects were eligible for entering in Period B (they were considered as "success" i.e. IGA equal to 0 or 1) and 757 out of these subjects decided to continue in Period B.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ivermectin 1% cream
    Reporting group description
    		 -

    Reporting group title
    Metronidazole 0.75% Cream
    Reporting group description
    		 -

    Reporting group values
    		 Ivermectin 1% cream Metronidazole 0.75% Cream Total
    Number of subjects
    		 478 484 962
    Age categorical
    age
    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)
    		 0 0 0
        Adults (18-64 years)
    		 394 398 792
        From 65-84 years
    		 83 85 168
        85 years and over
    		 1 1 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.22 ± 13.4 51.87 ± 13.24 -
    Gender categorical
    Units: Subjects
        Female
    		 311 316 627
        Male
    		 167 168 335

    End points

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    End points reporting groups
    Reporting group title
    Ivermectin 1% cream
    Reporting group description
    		 -

    Reporting group title
    Metronidazole 0.75% Cream
    Reporting group description
    		 -
    Reporting group title
    Ivermectin 1% cream
    Reporting group description
    		 -

    Reporting group title
    Metronidazole 0.75% Cream
    Reporting group description
    		 -

    Primary: % change reduction in inflammatory lesion

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    End point title
    		 % change reduction in inflammatory lesion
    End point description
    End point type
    Primary
    End point timeframe
    Inflammatory lesion counts were to be performed at Screening, Baseline, Week 3, Week 6, Week 9, Week 12, and Week 16/ ET visits.
    End point values
    		 Ivermectin 1% cream Metronidazole 0.75% Cream
    Number of subjects analysed
    478
    484
    Units: reduction of inflammatory lesions
    number (not applicable)
        % change reduction nber of lesions
    83
    74
    Statistical analysis title
    		 % change in inflammatory lesions counts ITT
    Statistical analysis description
    % change in inflammatory lesions counts ITT - LOCF
    Comparison groups
    Ivermectin 1% cream v Metronidazole 0.75% Cream
    Number of subjects included in analysis
    962
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Primary: time to first relapse

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    End point title
    		 time to first relapse
    End point description
    End point type
    Primary
    End point timeframe
    Time to first relapse defined as time to IGA > or = to 2
    End point values
    		 Ivermectin 1% cream Metronidazole 0.75% Cream
    Number of subjects analysed
    399
    358
    Units: days
    115
    85
    Statistical analysis title
    		 Time to relapse (days)
    Comparison groups
    Ivermectin 1% cream v Metronidazole 0.75% Cream
    Number of subjects included in analysis
    757
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0365
    Method
    		 Logrank test
    Confidence interval
    Statistical analysis title
    		 Time to relapse (days)
    Comparison groups
    Metronidazole 0.75% Cream v Ivermectin 1% cream
    Number of subjects included in analysis
    757
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0365
    Method
    		 Logrank test
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The study RD.03.SPR.40173 consisted of an initial 16-week treatment period (Period A) followed by a 36-week extension period (Period B).
    Adverse event reporting additional description
    The ratio subjects affected / exposed is calculated by EudraCT database and does not necessarily reflects ratios in clinical study reports taking into consideration other reporting threshold.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Ivermectin 1% cream period A
    Reporting group description
    		 -

    Reporting group title
    Metronidazole 0.75% cream period A
    Reporting group description
    		 -

    Reporting group title
    Ivermectin 1% cream period B
    Reporting group description
    		 -

    Reporting group title
    Metronidazole 0.75% cream period B
    Reporting group description
    		 -

    Serious adverse events
    		 Ivermectin 1% cream period A Metronidazole 0.75% cream period A Ivermectin 1% cream period B Metronidazole 0.75% cream period B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 478 (1.67%)
    5 / 484 (1.03%)
    10 / 399 (2.51%)
    11 / 359 (3.06%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    0 / 399 (0.00%)
    1 / 359 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 484 (0.21%)
    0 / 399 (0.00%)
    0 / 359 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 484 (0.00%)
    0 / 399 (0.00%)
    2 / 359 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral artery occlusion
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    0 / 399 (0.00%)
    1 / 359 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    1 / 399 (0.25%)
    0 / 359 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    0 / 399 (0.00%)
    1 / 359 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic sinusitis
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 484 (0.00%)
    0 / 399 (0.00%)
    0 / 359 (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
    Pneumonia
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 484 (0.00%)
    0 / 399 (0.00%)
    0 / 359 (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
    Psychiatric disorders
    Panic attack
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    0 / 399 (0.00%)
    1 / 359 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Brain herniation
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    1 / 399 (0.25%)
    0 / 359 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    1 / 399 (0.25%)
    0 / 359 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    whiplash injury
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 484 (0.00%)
    0 / 399 (0.00%)
    0 / 359 (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
    Congenital, familial and genetic disorders
    Vitello-intestinal duct remnant
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    1 / 399 (0.25%)
    0 / 359 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
    alternative dictionary used: MedDRA 12
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    1 / 399 (0.25%)
    0 / 359 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 484 (0.21%)
    0 / 399 (0.00%)
    1 / 359 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    1 / 399 (0.25%)
    0 / 359 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ischaemic stroke
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    1 / 399 (0.25%)
    1 / 359 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    1 / 399 (0.25%)
    0 / 359 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Macular degeneration
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    1 / 399 (0.25%)
    0 / 359 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 484 (0.21%)
    0 / 399 (0.00%)
    0 / 359 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    1 / 399 (0.25%)
    0 / 359 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    0 / 399 (0.00%)
    1 / 359 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 484 (0.00%)
    0 / 399 (0.00%)
    0 / 359 (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
    Inguinal hernia
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 484 (0.21%)
    0 / 399 (0.00%)
    0 / 359 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    1 / 399 (0.25%)
    0 / 359 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    1 / 399 (0.25%)
    1 / 359 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 484 (0.00%)
    0 / 399 (0.00%)
    0 / 359 (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
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 484 (0.21%)
    0 / 399 (0.00%)
    0 / 359 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    1 / 478 (0.21%)
    0 / 484 (0.00%)
    0 / 399 (0.00%)
    0 / 359 (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
    Infections and infestations
    Eczema infected
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    1 / 399 (0.25%)
    0 / 359 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    0 / 399 (0.00%)
    1 / 359 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    0 / 399 (0.00%)
    1 / 359 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection bacterial
         subjects affected / exposed
    0 / 478 (0.00%)
    0 / 484 (0.00%)
    0 / 399 (0.00%)
    1 / 359 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Ivermectin 1% cream period A Metronidazole 0.75% cream period A Ivermectin 1% cream period B Metronidazole 0.75% cream period B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    252 / 478 (52.72%)
    262 / 484 (54.13%)
    118 / 399 (29.57%)
    113 / 359 (31.48%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 478 (1.26%)
    4 / 484 (0.83%)
    4 / 399 (1.00%)
    7 / 359 (1.95%)
         occurrences all number
    6
    4
    4
    7
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 478 (3.14%)
    11 / 484 (2.27%)
    5 / 399 (1.25%)
    4 / 359 (1.11%)
         occurrences all number
    18
    17
    7
    6
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 478 (0.21%)
    5 / 484 (1.03%)
    4 / 399 (1.00%)
    1 / 359 (0.28%)
         occurrences all number
    1
    5
    4
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    5 / 478 (1.05%)
    1 / 484 (0.21%)
    0 / 399 (0.00%)
    1 / 359 (0.28%)
         occurrences all number
    6
    1
    0
    1
    Rhinitis
         subjects affected / exposed
    2 / 478 (0.42%)
    3 / 484 (0.62%)
    4 / 399 (1.00%)
    2 / 359 (0.56%)
         occurrences all number
    2
    4
    4
    6
    Cough
         subjects affected / exposed
    3 / 478 (0.63%)
    2 / 484 (0.41%)
    3 / 399 (0.75%)
    4 / 359 (1.11%)
         occurrences all number
    4
    2
    3
    4
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 478 (0.21%)
    5 / 484 (1.03%)
    3 / 399 (0.75%)
    0 / 359 (0.00%)
         occurrences all number
    1
    5
    4
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    7 / 478 (1.46%)
    4 / 484 (0.83%)
    6 / 399 (1.50%)
    5 / 359 (1.39%)
         occurrences all number
    10
    4
    8
    6
    Arthralgia
         subjects affected / exposed
    1 / 478 (0.21%)
    6 / 484 (1.24%)
    4 / 399 (1.00%)
    2 / 359 (0.56%)
         occurrences all number
    1
    7
    4
    2
    Arthritis
         subjects affected / exposed
    1 / 478 (0.21%)
    1 / 484 (0.21%)
    4 / 399 (1.00%)
    1 / 359 (0.28%)
         occurrences all number
    1
    1
    7
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    32 / 478 (6.69%)
    29 / 484 (5.99%)
    37 / 399 (9.27%)
    39 / 359 (10.86%)
         occurrences all number
    34
    34
    39
    44
    Influenza
         subjects affected / exposed
    9 / 478 (1.88%)
    10 / 484 (2.07%)
    12 / 399 (3.01%)
    6 / 359 (1.67%)
         occurrences all number
    9
    10
    12
    6
    Bronchitis
         subjects affected / exposed
    6 / 478 (1.26%)
    4 / 484 (0.83%)
    4 / 399 (1.00%)
    3 / 359 (0.84%)
         occurrences all number
    6
    4
    6
    3
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 478 (1.26%)
    4 / 484 (0.83%)
    1 / 399 (0.25%)
    0 / 359 (0.00%)
         occurrences all number
    7
    4
    2
    0
    Oral herpes
         subjects affected / exposed
    3 / 478 (0.63%)
    5 / 484 (1.03%)
    7 / 399 (1.75%)
    3 / 359 (0.84%)
         occurrences all number
    3
    5
    8
    3
    Pharyngitis
         subjects affected / exposed
    3 / 478 (0.63%)
    4 / 484 (0.83%)
    5 / 399 (1.25%)
    6 / 359 (1.67%)
         occurrences all number
    3
    4
    5
    6
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 484 (0.21%)
    5 / 399 (1.25%)
    2 / 359 (0.56%)
         occurrences all number
    0
    1
    5
    3
    Urinary tract infection
         subjects affected / exposed
    0 / 478 (0.00%)
    1 / 484 (0.21%)
    2 / 399 (0.50%)
    5 / 359 (1.39%)
         occurrences all number
    0
    1
    2
    5

    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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