Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Randomised controlled clinical trial to evaluate the efficacy of a sodium salicylate hydroglyceric solution used at different concentrations in the aesthetic and functional sclerotherapy of veins, venulae and ecstatic capillaries.

    Summary
    EudraCT number
    		 2004-005147-10
    Trial protocol
    		 IT  
    Global end of trial date
    25 May 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jun 2022
    First version publication date
    22 Jun 2022
    Other versions
    Summary report(s)
    		 study final report

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    KORPO - 0104
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    KORPO s.r.l.
    Sponsor organisation address
    Via XX settembre 5/28, Genova, Italy, I-16121
    Public contact
    Sergio Capurro, Korpo s.r.l., 0039 3394303430, info@korpo.com
    Scientific contact
    Sergio Capurro, Korpo s.r.l., 0039 3394303430, info@korpo.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
    12 Apr 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 May 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of a sodium salicylate hydroglyceric solution experimental name Bisclero used at different concentrations 6 and 10 in the aesthetic and functional sclerotherapy of veins, venulae and ecstatic capillaries by comparing the effects with those of a placebo solution of Ringer lactate.
    Protection of trial subjects
    Evaluation of tolerability through registration of all ADRs. In case of problem of tolerability, the treatment should be interrupted
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Mar 2006
    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
    Italy: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    51
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 60 patients of both sexes with bilateral lower-limb pathology, i.e. telangiectasias (diameter of ectasic capillaries not exceeding 1 mm, 30 subjects) or reticular veins (diameter of ectasic capillaries between 1 and 8 mm, 30 subjects) aged between 18 and 75 years, light phototype.

    Pre-assignment
    Screening details
    		 For the assessment of tolerability, all adverse events (serious and non-serious) observed during treatment and reported directly by the subject or noted by the investigator were recorded, recording for each of them. In the event of lack of tolerability, treatment would be discontinued

    Period 1
    Period 1 title
    15 days evaluation (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group Bisclero 6%
    Arm description
    		 Subject with diameter of ectasic capillary 1-8 mm
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bisclero 6%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravascular use , Intravenous use
    Dosage and administration details
    Buffered 6% sodium salicylate hydroglyceric solution for peripheral intravenous use

    Arm title
    		 Group Bisclero 10%
    Arm description
    		 Subject with diameter of ectasic capillary < 1 mm
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bisclero 10%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravascular use , Intravenous use
    Dosage and administration details
    Buffered 10% sodium salicylate hydroglyceric solution for peripheral intravenous use

    Number of subjects in period 1
    		Group Bisclero 6% Group Bisclero 10%
    Started
    30
    30
    Completed
    30
    30

    Baseline characteristics

    		 Close Top of page

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Group Bisclero 6%
    Reporting group description
    		 Subject with diameter of ectasic capillary 1-8 mm

    Reporting group title
    Group Bisclero 10%
    Reporting group description
    		 Subject with diameter of ectasic capillary < 1 mm

    Subject analysis set title
    ectasic capillary diameter 1-8mm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subject treated with low dosage drug product (Bisclero 6%)

    Subject analysis set title
    ectasic capillary diameter < 1mm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subject treated with high dosage drug product (Bisclero 10%)

    Primary: Visual evaluation of efficacy

    		 Close Top of page
    End point title
    		 Visual evaluation of efficacy [1]
    End point description
    The efficacy was determined on the basis of visual assessment of the ectasic vessels and measured on a visual-analogue scale taking into account four criteria: colour, density, relief and vessel surface (VAS scale, 0=maximum severity to 10=absence of lesion).
    End point type
    Primary
    End point timeframe
    15 days after treatment
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see enclosed document Evaluation of results
    End point values
    		 ectasic capillary diameter 1-8mm ectasic capillary diameter < 1mm
    Number of subjects analysed
    Units: 60
        VAS = 1
    1
    1
        VAS = 2
    1
    12
        VAS = 3
    11
    6
        VAS = 4
    8
    5
        VAS = 5
    3
    1
        VAS = 6
    5
    3
        VAS = 7
    0
    1
        VAS = 8
    1
    1
        VAS = 9
    0
    0
        VAS = 10
    0
    0
    Attachments
    		 Statistical evaluation
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    15 days after second treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8.0
    Reporting groups
    Reporting group title
    Patient treated with Bisclero 6%
    Reporting group description
    		 -

    Reporting group title
    Patient treated with Bisclero 10%
    Reporting group description
    		 -

    Serious adverse events
    		 Patient treated with Bisclero 6% Patient treated with Bisclero 10%
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Patient treated with Bisclero 6% Patient treated with Bisclero 10%
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    Skin and subcutaneous tissue disorders
    hyperpigmentation
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 19 13:14:51 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA