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    Summary
    EudraCT Number:2007-000532-47
    Sponsor's Protocol Code Number:KF 01/06
    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:2009-08-11
    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 number2007-000532-47
    A.3Full title of the trial
    Singleblind, randomized, verum-controlled, multicentric study to confirm the non-inferiority of Leukichtan Gel versus Betaisodona Salbe in the treatment of cuts, abrasions and burns
    A.4.1Sponsor's protocol code numberKF 01/06
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorICHTHYOL-GESELLSCHAFT Cordes, Hermanni & Co. (GmbH & Co.) KG
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Leukichtan Gel
    D.2.1.1.2Name of the Marketing Authorisation holderICHTHYOL-GESELLSCHAFT
    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.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium Bituminosulfonate
    D.3.9.1CAS number 1340-06-3
    D.3.9.3Other descriptive nameNatriumbituminosulfonate, hell
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typemedicinal product containing an active substance of natural origin
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Betaisodona Salbe
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma GmbH
    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.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 25655-41-8
    D.3.9.3Other descriptive namePOVIDONE, IODINATED
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 No
    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
    cuts, abrasions and burns
    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
    Confirmation of the non-inferiority of Leukichtan Gel versus Betaisodona Salbe in the treatment of superficial skin injuries (cuts, abrasions and burns) measured as amount of patients with complete epithelisation of the wound during the treatment period.
    E.2.2Secondary objectives of the trial
    a) Confirmation of the non-inferiority of Leukichtan Gel versus Betaisodona Salbe in the treatment of skin injuries (cuts, abrasions and burns) measured as
    - amount of patients with complete granulation of the wound
    - enlargement of the granulated area of the wound
    - time until the complete epithelisation of the wound
    - wound infection, erythema, fibrin coating
    - pain evaluation by investigator and by patient (from the age of 5 years) via
    patient's questionnaire at every visit
    - evaluation of therapy success by investigator and by patient (from 5 years) via
    patient's questionnaire at every visit
    - over all evaluation of therapy success by investigator at the end of study
    b) the comparability of tolerance
    At study start and at every visit, the tolerance of therapy will be evaluated by investigator and by patient (from 5 years) via patient's questionnaire.
    Furthermore, investigator evaluates the over all tolerance at the end of study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    · age: 7 months - 80 years
    · male or female Caucasians
    · voluntary participation in the study
    · existence of a written consent of the patient, for patients under 18 years of age
    additionally with signature of a legal representative
    · diagnosis: superficial, fresh cuts, abrasions or burns, grade I-II, not older than
    2 days
    · Safe contraception (female patients) according to Pearl Index < 1 - fulfilled as
    follows: (one of the following items has to be answered with “yes”)
    - hormonal contraception via estrogens and progestogens for example:
    o Combined hormonal contraceptive pill (estrogens and progestogens)
    o Mini pill (progestogens only)
    o Contraceptive vaginal ring (ring with estrogens and progestogens)
    o Contraceptive Patch (estrogens and progestogens)
    o Intrauterine systems (IUS) (with progestogens)
    - sterilisation
    - Sexual abstinence (reliable statement) / vasectomised partner
    E.4Principal exclusion criteria
    · injuries older than 2 days (corresponding to 48 hours)
    · cuts > 10 cm, abrasions or burns > 100 cm2
    · severe concomitant diseases (i.e. liver-/kidney disorders, metabolism disorders,
    tumors in the anamnesis)
    · hyperthyreosis or other manifest thyroid disease
    · dermatitis herpetiformis Duhring
    · patient was or will be treated before or after the study with a radio-iodine-therapy
    · patient with bland adenomatous goiter
    · predisposed patient with autonomic adenomas resp. functional autonomy
    · known hypersensitivity / allergy against iodine or Sodium bituminosulfonate, pale or
    one of the other ingredients of the investigational product
    · simultaneous application of enzymatic wound treatment
    · simultaneous application of hydrogen peroxide and Taurolidin as well as disinfectants
    containing silver or wound dressings containing silver (formation of silver iodide)
    · simultaneous or shortly subsequent treatment with disinfectants containing
    quicksilver (risk of chemical burn due to formation of quicksilver iodide)
    · existence of diseases that require systemic application of antibiotics or steroids
    and/or topical administration of antibiotics or steroids in the area of the skin injury
    · oral and/or topical therapy with corticosteroids
    · application of other medicinal and/or cosmetical products that can influence the
    therapy during the study
    · alcohol, drugs or medicins abuse
    · physical or psycological diseases where the adherence to the protocol
    appears to be questionable
    · lacking compliance
    · pregnancy, lactation
    · first-time intake of hormonal contraceptives or change of contraceptives within the
    last 3 months
    · participation in another clinical trial within the last 30 days, planned participation
    in another clinical trial within the duration of this study
    · previous participation within this study
    E.5 End points
    E.5.1Primary end point(s)
    visite 4 = final examination after 14 days treatment
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    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 Information not present in EudraCT
    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
    end of the trial = the last visit of the last subject undergoing the trial
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-08-11. Yes
    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
    patients from 7th month of age can be included in the study (regarding inclusion criteria)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    after the patients have ended the participation in the trial, no special care is necessary.
    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 Decision2010-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-01
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