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    Clinical Trial Results:
    Evaluation of the antiseptic activity of 4 different modes of application of a 5% alcoholic povidone-iodine product (Bétadine® Alcoolique 5%)

    Summary
    EudraCT number
    		 2019-000694-24
    Trial protocol
    		 FR  
    Global end of trial date
    07 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Nov 2021
    First version publication date
    06 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    X-00069-3322
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Meda Pharma GmbH & Co. KG (A Mylan company)
    Sponsor organisation address
    Benzstraße 1, Bad Homburg, Germany, 61352
    Public contact
    Clinical Affairs GKB, Meda Pharma GmbH & Co. KG (A Mylan company), 49 61728881425, susanne.horner@viatris.com
    Scientific contact
    Clinical Affairs GKB, Meda Pharma GmbH & Co. KG (A Mylan company), 49 61728881425, susanne.horner@viatris.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
    23 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this clinical trial is to evaluate the antiseptic activity of a 5% alcoholic povidone-iodine solution (Bétadine® Alcoolique 5%) applied with 4 different modes of application
    Protection of trial subjects
    Study involved topical application of the medication over a specific period up to 30 mins, post which the application was rinsed off with soap and water. No specific additional measures were required to minimize distress given the nature of study. The subjects were provided with informed consents prior to start of any study procedures. Subjects could withdraw from treatment at any time and for any reason.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jun 2020
    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
    France: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    31
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Main study started after the confirmation of the method validation. An in-vitro and an in-vivo formed method validation. For the in-vivo validation, 20 subjects in addition to subjects in the main study were included and In-vivo recruitment started on 02 Sep 2019. Main study had 32 subjects and recruitment for main study started on 22 Jun 2020.

    Pre-assignment
    Screening details
    		 Healthy male and non-pregnant females (including non-pregnant females of child-bearing potential using acceptable methods of contraception) aged between 18 and 65 years (inclusive), with a BMI ≤ 30, having adequate back size to cover 4 application fields of 10 x 10 cm, having a minimum CFU count of 2.5 log10/cm2 at screening visit.

    Pre-assignment period milestones
    Number of subjects started
    		 32
    Intermediate milestone: Number of subjects
    Main study: 32
    Number of subjects completed
    		 32

    Period 1
    Period 1 title
    Main study: Baseline CFU sampling
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Baseline CFU Treatment A
    Arm description
    		 Baseline CFU sampling for treatment A: 3 mL Bétadine® Alcoolique 5% applied in spiral movement starting in the center of a 10 x 10 cm zone (snailing method, 3 mL)
    Arm type
    		 Baseline sampling

    Investigational medicinal product name
    Bétadine® Alcoolique 5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Before baseline sampling, no product has been applied.

    Arm title
    		 Baseline CFU Treatment B
    Arm description
    		 Baseline CFU for treatment B: 10 mL Bétadine® Alcoolique 5% applied in spiral movement starting in the center of a 10 x 10 cm zone (snailing method, 10 mL)
    Arm type
    		 Baseline sampling

    Investigational medicinal product name
    Bétadine® Alcoolique 5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Before baseline sampling, no product has been applied.

    Arm title
    		 Baseline CFU Treatment C
    Arm description
    		 Baseline CFU sampling for treatment C: 3 mL Bétadine® Alcoolique 5% applied by back and forth movements horizontally and vertically covering a 10 x 10 cm zone (scraping method, 3 mL)
    Arm type
    		 Baseline sampling

    Investigational medicinal product name
    Bétadine® Alcoolique 5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Before baseline sampling, no product has been applied.

    Arm title
    		 Baseline CFU Treatment D
    Arm description
    		 Baseline CFU sampling for Treatment D: 10 mL Bétadine® Alcoolique 5% applied by back and forth movements horizontally and vertically covering a 10 x 10 cm zone (scraping method, 10 mL).
    Arm type
    		 Baseline sampling

    Investigational medicinal product name
    Bétadine® Alcoolique 5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Before baseline sampling, no product has been applied.

    Investigational medicinal product name
    Bétadine® Alcoolique 5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Before baseline sampling, no product has been applied.

    Number of subjects in period 1
    		Baseline CFU Treatment A Baseline CFU Treatment B Baseline CFU Treatment C Baseline CFU Treatment D
    Started
    32
    32
    32
    32
    Completed
    32
    32
    32
    32
    Period 2
    Period 2 title
    Main study: Post-Treatment CFU sampling
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Treatment A:
    Arm description
    		 3 mL Bétadine® Alcoolique 5% applied in spiral movement starting in the center of a 10 x 10 cm zone (snailing method, 3 mL)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bétadine® Alcoolique 5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    3 mL Bétadine® Alcoolique 5% applied in spiral movement starting in the center of a 10 x 10 cm zone (snailing method, 3 mL),

    Arm title
    		 Treatment B
    Arm description
    		 10 mL Bétadine® Alcoolique 5% applied in spiral movement starting in the center of a 10 x 10 cm zone (snailing method, 10 mL)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bétadine® Alcoolique 5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    10 mL Bétadine® Alcoolique 5% applied in spiral movement starting in the center of a 10 x 10 cm zone (snailing method, 10 mL)

    Arm title
    		 Treatment C
    Arm description
    		 3 mL Bétadine® Alcoolique 5% applied by back and forth movements horizontally and vertically covering a 10 x 10 cm zone (scraping method, 3 mL)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bétadine® Alcoolique 5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    3 mL Bétadine® Alcoolique 5% applied by back and forth movements horizontally and vertically covering a 10 x 10 cm zone (scraping method, 3 mL)

    Arm title
    		 Treatment D
    Arm description
    		 10 mL Bétadine® Alcoolique 5% applied by back and forth movements horizontally and vertically covering a 10 x 10 cm zone (scraping method, 10 mL)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bétadine® Alcoolique 5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    10 mL Bétadine® Alcoolique 5% applied by back and forth movements horizontally and vertically covering a 10 x 10 cm zone (scraping method, 10 mL)

    Number of subjects in period 2
    		Treatment A: Treatment B Treatment C Treatment D
    Started
    32
    32
    32
    32
    Completed
    32
    32
    32
    32

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main study: Baseline CFU sampling
    Reporting group description
    		 -

    Reporting group values
    		 Main study: Baseline CFU sampling Total
    Number of subjects
    		 32 32
    Age categorical
    Healthy male and/or female subjects aged between 18 and 65 years (inclusive).
    Units: Subjects
        Adults (18-64 years)
    		 31 31
        From 65-84 years
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 18 18
        Male
    		 14 14
    Subject analysis sets

    Subject analysis set title
    Change of CFU count treatment A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Change of CFU count (in log10/cm2) from baseline -Treatment A (3 mL, Snail)

    Subject analysis set title
    Change of CFU count treatment B
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Change of CFU count (in log10/cm2) from baseline - Treatment B (10 mL, Snail)

    Subject analysis set title
    Change of CFU count treatment C
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Change of CFU count (in log10 /cm2) from baseline - Treatment C (3mL, Scrape)

    Subject analysis set title
    Change of CFU count treatment D
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Change of CFU count (in log10 /cm2) from baseline - Treatment D (10mL, Scrape)

    Subject analysis sets values
    		 Change of CFU count treatment A Change of CFU count treatment B Change of CFU count treatment C Change of CFU count treatment D
    Number of subjects
    26
    25
    27
    27
    Age categorical
    Healthy male and/or female subjects aged between 18 and 65 years (inclusive).
    Units: Subjects
        Adults (18-64 years)
    25
    24
    26
    26
        From 65-84 years
    1
    1
    1
    1
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Baseline CFU Treatment A
    Reporting group description
    		 Baseline CFU sampling for treatment A: 3 mL Bétadine® Alcoolique 5% applied in spiral movement starting in the center of a 10 x 10 cm zone (snailing method, 3 mL)

    Reporting group title
    Baseline CFU Treatment B
    Reporting group description
    		 Baseline CFU for treatment B: 10 mL Bétadine® Alcoolique 5% applied in spiral movement starting in the center of a 10 x 10 cm zone (snailing method, 10 mL)

    Reporting group title
    Baseline CFU Treatment C
    Reporting group description
    		 Baseline CFU sampling for treatment C: 3 mL Bétadine® Alcoolique 5% applied by back and forth movements horizontally and vertically covering a 10 x 10 cm zone (scraping method, 3 mL)

    Reporting group title
    Baseline CFU Treatment D
    Reporting group description
    		 Baseline CFU sampling for Treatment D: 10 mL Bétadine® Alcoolique 5% applied by back and forth movements horizontally and vertically covering a 10 x 10 cm zone (scraping method, 10 mL).
    Reporting group title
    Treatment A:
    Reporting group description
    		 3 mL Bétadine® Alcoolique 5% applied in spiral movement starting in the center of a 10 x 10 cm zone (snailing method, 3 mL)

    Reporting group title
    Treatment B
    Reporting group description
    		 10 mL Bétadine® Alcoolique 5% applied in spiral movement starting in the center of a 10 x 10 cm zone (snailing method, 10 mL)

    Reporting group title
    Treatment C
    Reporting group description
    		 3 mL Bétadine® Alcoolique 5% applied by back and forth movements horizontally and vertically covering a 10 x 10 cm zone (scraping method, 3 mL)

    Reporting group title
    Treatment D
    Reporting group description
    		 10 mL Bétadine® Alcoolique 5% applied by back and forth movements horizontally and vertically covering a 10 x 10 cm zone (scraping method, 10 mL)

    Subject analysis set title
    Change of CFU count treatment A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Change of CFU count (in log10/cm2) from baseline -Treatment A (3 mL, Snail)

    Subject analysis set title
    Change of CFU count treatment B
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Change of CFU count (in log10/cm2) from baseline - Treatment B (10 mL, Snail)

    Subject analysis set title
    Change of CFU count treatment C
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Change of CFU count (in log10 /cm2) from baseline - Treatment C (3mL, Scrape)

    Subject analysis set title
    Change of CFU count treatment D
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Change of CFU count (in log10 /cm2) from baseline - Treatment D (10mL, Scrape)

    Primary: Antiseptic activity of Bétadine® Alcoolique

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    End point title
    		 Antiseptic activity of Bétadine® Alcoolique
    End point description
    The primary endpoints were defined as follows: Evaluation of antiseptic activity of a 5% alcoholic povidone-iodine solution (Bétadine® Alcoolique 5%) by measuring the change from baseline in log10/cm2 CFU counts for total aerobic and facultative anaerobic bacteria using 4 different modes of applications. Results are presented for per protocol population.
    End point type
    Primary
    End point timeframe
    Baseline sampling and post-treatment sampling for all 4 modes of application were collected during Visit 1.
    End point values
    		 Baseline CFU Treatment A Treatment A: Baseline CFU Treatment B Treatment B Baseline CFU Treatment C Treatment C Baseline CFU Treatment D Treatment D Change of CFU count treatment A Change of CFU count treatment B Change of CFU count treatment C Change of CFU count treatment D
    Number of subjects analysed
    26
    26
    25
    27
    27
    27
    27
    27
    26
    25
    27
    27
    Units: CFU
        log mean (standard deviation)
    3.473 ± 0.714
    0.351 ± 0.796
    3.391 ± 0.719
    0.066 ± 0.463
    3.594 ± 0.747
    0.104 ± 0.629
    3.450 ± 0.820
    -0.013 ± 0.535
    -3.122 ± 0.779
    -3.339 ± 0.715
    -3.491 ± 0.605
    -3.463 ± 0.749
    Statistical analysis title
    		 Inferential analysis - Treatment A (3 mL, Snail)
    Statistical analysis description
    Covariate adjusted change in log10 CFU/cm2 count from baseline - Treatment A (3mL, Snail)
    Comparison groups
    Baseline CFU Treatment A v Treatment A:
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 ≤ 0.1
    Method
    		 Mixed models analysis
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Notes
    [1] - 26 subjects were analyzed for log10 CFU count as part of baseline on A and 26 subjects subjects were analyzed for log10 CFU count as part of post treatment on A, giving 52 observations. Analysis was based on 26 subjects due to the cross-over design.
    Statistical analysis title
    		 Inferential analysis - Treatment B (10 mL, Snail)
    Statistical analysis description
    Covariate adjusted change in log10 CFU/cm2 count from baseline - Treatment B (10mL, Snail)
    Comparison groups
    Baseline CFU Treatment B v Treatment B
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 ≤ 0.1
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Notes
    [2] - 25 subjects were analyzed for log10 CFU count as part of baseline on B and 27 subjects subjects were analyzed for log10 CFU count as part of post treatment on B, giving 52 observations. Analysis was based on 25 subjects due to the cross-over design.
    Statistical analysis title
    		 Inferential analysis - Treatment C (3mL, Scrape)
    Statistical analysis description
    Covariate adjusted change in log10 CFU/cm2 count from baseline - Treatment C (3mL, Scrape)
    Comparison groups
    Baseline CFU Treatment C v Treatment C
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 ≤ 0.1
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Notes
    [3] - 27 subjects were analyzed for log10 CFU count as part of baseline on C and 27 subjects subjects were analyzed for log10 CFU count as part of post treatment on C, giving 54 observations. Analysis was based on 27 subjects due to the cross-over design.
    Statistical analysis title
    		 Inferential analysis - Treatment D (10mL, Scrape)
    Statistical analysis description
    Covariate adjusted change in log10 CFU/cm2 count from baseline - Treatment D (10mL, Scrape)
    Comparison groups
    Baseline CFU Treatment D v Treatment D
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 ≤ 0.1
    Method
    		 Mixed models analysis
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Notes
    [4] - 27 subjects were analyzed for log10 CFU count as part of baseline on D and 27 subjects subjects were analyzed for log10 CFU count as part of post treatment on D, giving 54 observations. Analysis was based on 27 subjects due to the cross-over design.
    Statistical analysis title
    		 Inferential analysis - A vs. B
    Statistical analysis description
    Covariate adjusted change in log10 CFU/cm2 count from baseline - A vs. B (3 mL vs. 10 mL for Snail)
    Comparison groups
    Change of CFU count treatment A v Change of CFU count treatment B
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 ≤ 0.1
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Notes
    [5] - 26 subjects were analyzed for change from baseline on A and 25 subjects were analyzed for change from baseline on B giving 51 observations. Analysis was based on 25 subjects due to the crossover design.
    Statistical analysis title
    		 Inferential analysis - C vs. D
    Statistical analysis description
    Covariate adjusted change in log10 CFU/cm2 count from baseline - C vs. D (3 mL vs. 10 mL for Scrape)
    Comparison groups
    Change of CFU count treatment C v Change of CFU count treatment D
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 ≤ 0.1
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Notes
    [6] - 27 subjects were analyzed for change from baseline on C and 27 subjects were analyzed for change from baseline on D giving 54 observations. Analysis was based on 27 subjects due to the crossover design.
    Statistical analysis title
    		 Inferential analysis - A vs. C
    Statistical analysis description
    Covariate adjusted change in log10 CFU/cm2 count from baseline - A vs. C (Snail vs. Scrape, 3mL)
    Comparison groups
    Change of CFU count treatment A v Change of CFU count treatment C
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 ≤ 0.1
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Notes
    [7] - 26 subjects were analyzed for change from baseline on A and 27 subjects were analyzed for change from baseline on C giving 53 observations. Analysis was based on 26 subjects due to the crossover design.
    Statistical analysis title
    		 Inferential analysis - B vs. D
    Statistical analysis description
    25 subjects were analyzed for change from baseline on B and 27 subjects were analyzed for change from baseline on D giving 52 observations. Analysis was based on 25 subjects due to the crossover design.
    Comparison groups
    Change of CFU count treatment B v Change of CFU count treatment D
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 ≤ 0.1
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Notes
    [8] - 25 subjects were analyzed for change from baseline on B and 27 subjects were analyzed for change from baseline on D giving 52 observations. Analysis was based on 25 subjects due to the crossover design.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Subjects were monitored or any Adverse event from signing of the informed consent until D1 treatment visit. All AEs that occurred after the first dose of study medication through 30 days after the last dose were considered to be treatment emergent AEs
    Adverse event reporting additional description
    Subjects were routinely queried regarding presence or absence of adverse events using open ended questions. Laboratory tests and Physical examinations were also undertaken. Date, time of assessment and the outcome were recorded.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: During this study neither non-serious nor serious adverse events occurred.

    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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