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    Summary
    EudraCT Number:2012-000362-38
    Sponsor's Protocol Code Number:BBW-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:2012-04-04
    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 number2012-000362-38
    A.3Full title of the trial
    Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 versus Standard of Care in Accelerating the Healing of Grade 2a Partial-Thickness Burn Wounds
    Offene, verblindet ausgewertete, prospektive, kontrollierte, randomisierte multi-zentrische Phase III Studie zum intra-individuellen Vergleich der Wirksamkeit und Verträglichkeit von Oleogel-S10 gegenüber der Standardbehandlung in der Beschleunigung der Heilung von Grad 2a-Brandwunden
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Unblinded Designed, Evaluated by Blinded Experts, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare within each single patient the Efficacy and Tolerance of Oleogel-S10 versus Standard of Care in Accelerating the Healing of Superficial Burn Wounds that heal by itself without external intervention
    A.3.2Name or abbreviated title of the trial where available
    Oleogel-S10 in Grade 2a Burn Wounds
    A.4.1Sponsor's protocol code numberBBW-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 SponsorBirken 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 supportBirken AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBirken AG
    B.5.2Functional name of contact pointBusiness Unit Pharma
    B.5.3 Address:
    B.5.3.1Street AddressAm Hauptbahnhof 10
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post code60329
    B.5.3.4CountryGermany
    B.5.4Telephone number4972339749130
    B.5.5Fax number496990020617
    B.5.6E-mailk.schorn@birken.eu
    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 No
    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 nameOleogel-S10
    D.3.4Pharmaceutical form 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 INNDry extract from Betulae cortex (Birch cork) (5-10 : 1), quantification: 72-88% Betulin, extraction solvent: n-Heptane 95% m/m
    D.3.9.2Current sponsor codeTE
    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) 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 Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    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 octenilin® Wound Gel
    D.2.1.1.2Name of the Marketing Authorisation holderSchuelke & Mayr
    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 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 INNOCTENIDINE DIHYDROCHLORIDE
    D.3.9.1CAS number 70775-75-6
    D.3.9.4EV Substance CodeSUB03484MIG
    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) 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 typeMedical device
    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 partial-thickness (grade 2a) burn wounds
    E.1.1.1Medical condition in easily understood language
    Burn with loss of upper skin (blister, ruptured blister), able to heal by itself
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10006802
    E.1.2Term Burns second degree
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare intra-individually the efficacy and tolerance of Oleogel-S10 with fatty gauze as wound dressing versus Standard of Care (defined as octenilin® Wound Gel) with fatty gauze as wound dressing in accelerating the healing of grade 2a burns.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients at least 18 years old who have provided written informed consent.
    • Presenting with acute grade 2a burn wounds (as graded by an expert surgeon assisted by LDI or a multispectral imaging system) within 48 hours after injury.
    • Burn wound caused by fire burn, heat burn or scalding.
    • Burn patients with grade 2a burn wounds between 80 cm2 and less than 25% of their TBSA (alternatively, 2 comparable wounds with size more than 40 cm2 each and less than 12.5% of the TBSA each are allowed).
    • Patient is able to understand the Informed Consent Form provided and is prepared to comply with all study requirements, including the following: Visiting the trial site for wound dressing changes at least every second day (if patient is not hospitalized) and photo documentation until full wound closure or until the investigator decides to change medication and/or treatment after day 21 after start of treatment; visiting the trial site for two follow up visits after 3 and 12 months.
    • Willing to perform all necessary wound dressing changes at the trial site. Also the patient needs to agree to return to site for 3 and 12 months follow-up visits.
    • Women of childbearing potential must apply highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly (e.g., implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner)).
    E.4Principal exclusion criteria
    • Suffering from chemical burns, or electrical burns or sunburns.
    • Having already received treatment for their burn with silver sulfadiazine (obscures photographic wound evaluation).
    • Positive blood culture after the burn.
    • Diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerance or efficacy.
    • A skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
    • A history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
    • Known multiple allergic disorders.
    • Taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
    • Inappropriate to participate in the study, for any reason, in the opinion of the Investigator.
    • Pregnant or breast feeding women are not allowed to participate in the study.
    • Mental incapacity or language barriers precluding adequate understanding or co-operation or willingness to follow study procedures.
    • Previous participation in this study.
    • Employee at the investigational site, relative or spouse of the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with earlier healing (at least 95% epithelialization) of the wound half treated with Oleogel S10 compared to standard of care (octenilin® Wound Gel), as evaluated by the majority decision of three independent, blinded experts.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At every wound dressing change (at least every second day until full wound closure is achieved)
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints
    A. Percentage of patients with earlier healing of wound half treated with Oleogel-S10 compared to octenilin® Wound Gel, evaluated separately for each of the three independent, blinded experts
    B. Percentage of patients with earlier healing of wound half treated with Oleogel-S10 compared to all other patients (earlier healing of wound half treated with octenilin® Wound Gel or no difference between treatment regimes)
    C. Intra-individual difference in time to wound closure between wound halves, either treated with Oleogel-S10 and fatty gauze as wound dressing or treated with octenilin® Wound Gel and fatty gauze as wound dressing
    D. Time from study start after burn accident until wound closure is achieved separately for wound halves treated with Oleogel-S10 and fatty gauze as wound dressing vs. octenilin® Wound Gel and fatty gauze as wound dressing
    E. Percentage of patients with wound closure at different time points
    F. Percentage of wound epithelialization at different time points as assessed by the Investigator
    G. Assessment of efficacy (evaluated by both the Investigators and patients)
    H. Cosmetic outcome after 3 and 12 months after burn accident, in relation to texture, redness, growth of hair and pigmentation, based on blinded photo evaluation

    Safety Endpoints
    I. Assessment of tolerance (evaluated by both the Investigators and patients)
    J. PK data: Systemic presence/concentration of betulin in blood plasma samples
    K. Microbial colonization
    L. Assessment of adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    A) to F), J):
    At every wound dressing change (at least every second day until
    full wound closure is achieved)

    G), I), K):
    At Days 7 (+/- 1 day), 14 (+/- 1 day), 21 / end of treatment

    H):
    After 3 and 12 months

    J):
    At Days 0, 7 (+/- 1 day), 14 (+/- 1 day), 21 / end of treatment

    L):
    At Day 0, at every wound dressing change, at Day 21 / end of 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    intra-individual comparison of two treatment regimes
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Medical device
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Germany
    Sweden
    Switzerland
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 No
    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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    If the patient completes the clinical trial as expected his/her grade 2a burn wounds are completely epithelialized. In this case no further treatment is necessary.
    If the patient's grade 2a burn wounds are not completely epithelialized after day 21 the investigator may choose a different therapy option, e.g. split-thickness skin grafting.
    After any other early discontinuation of the trial, patients will be treated according to individual needs at the discretion of the Investigator.
    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 Decision2012-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-04
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