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   43871   clinical trials with a EudraCT protocol, of which   7290   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

    Print Download

    Summary
    EudraCT Number:2011-002755-34
    Sponsor's Protocol Code Number:SWB-06-11
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-09
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2011-002755-34
    A.3Full title of the trial
    Open clinical study to determine the compatibility of Pyolysin®-Salbe in children aged between 0 and 17 years during the dermatological treatment of superficial wounds
    Offene klinische Studie zur Verträglichkeit von Pyolysin®-Salbe an Kindern im Alter von 0 - 17 Jahren bei dermatologischen Behandlungen von oberflächlichen Wunden
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to approve the compatibility of Pyolysin®-Salbe in children having superfical wounds
    Klinische Studie um die Verträglichkeit der Pyolysin®-Salbe bei Kindern mit oberflächlichen Wunden zu bestätigen.
    A.3.2Name or abbreviated title of the trial where available
    Clinical study Pyolysin®-Salbe in children
    Klinikstudie Pyolysin®-Salbe an Kindern
    A.4.1Sponsor's protocol code numberSWB-06-11
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSerumwerk Bernburg AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSerumwerk Bernburg AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFORIM GmbH
    B.5.2Functional name of contact pointManaging Director
    B.5.3 Address:
    B.5.3.1Street AddressDynamostraße 19
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code68165
    B.5.3.4CountryGermany
    B.5.4Telephone number0049062140046027
    B.5.5Fax number0049062140046010
    B.5.6E-mailspmueller@forim.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Pyolysin®-Salbe
    D.2.1.1.2Name of the Marketing Authorisation holderSerumwerk Bernburg AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePyolysin®-Salbe
    D.3.4Pharmaceutical form Cutaneous spray, ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPyolysin Kulturfiltrat
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number24,89g/100g Creme
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1314-13-2
    D.3.9.3Other descriptive nameZINC OXIDE
    D.3.9.4EV Substance CodeSUB12623MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6,9g/100g Creme
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 69-72-7
    D.3.9.3Other descriptive nameSALICYLIC ACID
    D.3.9.4EV Substance CodeSUB15180MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,5g/100g creme
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typePyolysin particle free and lysed cells filtrate of bacterial cultures such as Pseudomonas aeruginosa, Staph. aureus, E.-coli, Strep. Pyogenes, E. faecalis
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Superficial wounds in children aged between 0 and 17 years such as wounds caused by scraping, abrasions, bagatell injuries
    Oberflächliche Wunden bei Kindern im Alter von 0 - 17 Jahren wie z.B. Schürfwunden, Wunden durch Kratzeffekte und Bagatellverletzungen
    E.1.1.1Medical condition in easily understood language
    Superficial wounds in children aged between 0 and 17 years
    Oberflächliche Wunden bei Kindern im Alter von 0 - 17 Jahren
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the compatibility of the Pyolysin-Salbe in the age group from 0 to 17 years
    Bestätigung der Verträglichkeit von Pyolysin-Salbe in der Altersgruppe 0 - 17 Jahre
    E.2.2Secondary objectives of the trial
    Additional information on the wound healing process
    Zusätzliche Informationen über den Verlauf der Wundheilung
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age between 0-17 years
    bagatell injuries
    wounds caused by scraping
    superficial wounds
    outpatients
    sufficient german language skills
    the patient and/or the guarding should be able to keep the record in the study diary
    Alter von 0-17 Jahren
    Bagatellverletzung
    Schürfwunden
    Wunden durch Kratzeffekte
    Oberflächliche Wunden
    Ambulante Patienten
    Patient und/oder gesetzlicher Vertreter müssen in der Lage sein, das Studienbuch zu führen
    Ausreichende Deutschkenntnisse
    E.4Principal exclusion criteria
    Age above 17 years
    Known incompatibility of the investigational product
    Infected/superinfected wounds
    Internal medication with antihistamines, antibiotics, analgetics or immunosuppressants
    inpatients
    severe atopic dermatitis
    Pregnancy
    women of child bearing potential not using contraception
    Patient and/or the guarding are not able to keep the records in the study diary
    Participation in other clinical trials
    Alter über 17 Jahre
    Bekannte Überempfindlichkeit gegenüber dem Prüfpräparat
    Superinfizierte Wunden
    Patienten mit interner Medikation von Antibiotika und/oder Immunsuppressiva, Schmerzmedikation, Antihistaminika während der Behandlungsdauer
    Großflächige atopische Dermatitis
    Schwangerschaft
    geschlechtsreife Mädchen ohne effektive Kontrazeption
    Patient und/oder gesetzlicher Vertreter sind nicht in der Lage das Studienbuch zu führen
    Teilnahme an anderen klinischen Studien
    E.5 End points
    E.5.1Primary end point(s)
    Compatibility of the inversigational product
    Measured by visual scores considering the feeling of the skin after the application of the investigational product and the existence of pruritus. Furthermore the adapted SCORAD scoring is used
    Verträglickeit des Prüfpräparates
    Gemessen durch verschiedene visuelle Scores zur Hautverträglichkeit, zum Juckreiz und zum HAutgefühl nach Salbenapplikation.
    Zudem wir der adaptierte Score nach SCORAD verwendet
    E.5.1.1Timepoint(s) of evaluation of this end point
    At day 0, 7, 14, 21
    Additionally it is investigated by the patients and/or the guarding every day after the application (twice) of the investigational product and noted in the study diary
    Am Tag 0, 7, 14 und 21
    Zudem wird die Verträglickeit durch den Patienten und/oder seinen gesetzlichen Vertreter jeden Tag nach der Applikation (zweimalig) untersucht und im Studientagebuch notiert.
    E.5.2Secondary end point(s)
    Additional information on the wound healing progress-efficacy
    Zusätzliche Informationen über den Wundheilungsverlauf- Wirksamkeit
    E.5.2.1Timepoint(s) of evaluation of this end point
    At day 0, 7, 14, 21
    An Tag 0, 7, 14, 21
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is the last visit of the last subject undergoing the trial
    LVLS
    Das Ende der Studie ist die letzte Visite des letzten Patienten der Studie
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 120
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 40
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 40
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Very young children are not able to give the consent personally. As soon as they are able to give an "assent" they are asked to do so.
    Säuglinge und Kleinkinder sind nicht in der Lage selbständig ihre Einwilligung zu bekunden. Sobald sie dazu in der Lage sind, werden sie gebeten einen "Assent" auszufüllen und/oder ihre Einwilligung mündlich mitzuteilen
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-03
    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-Sun May 05 12:25:11 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA