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    Summary
    EudraCT Number:2014-001374-34
    Sponsor's Protocol Code Number:6630-0450-01
    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:2014-04-23
    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 number2014-001374-34
    A.3Full title of the trial
    A monocentric, observer-blind, randomized clinical study using an abrasive wound model with an intra-individual comparison to investigate the wound healing properties of a topical wound healing product in comparison to untreated and a reference product in 36 healthy subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Wound healing properties of a topical wound healing product
    A.4.1Sponsor's protocol code number6630-0450-01
    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 SponsorMEDICE Arzneimittel Pütter 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 supportMEDICE Arzneimittel Pütter GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationproDERM GmbH
    B.5.2Functional name of contact pointnot applicable
    B.5.3 Address:
    B.5.3.1Street AddressKiebitzweg 2
    B.5.3.2Town/ citySchenefeld
    B.5.3.3Post code22869
    B.5.3.4CountryGermany
    B.5.6E-mailahougardy@proDERM.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 Soventol Wund- und Heilgel
    D.2.1.1.2Name of the Marketing Authorisation holderMedice Arzneimittel Pütter GmbH & Co. KG
    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.3.11 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) 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 typeThe test product is a medical device
    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 Bepanthen Wund- und Heilsalbe
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital 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 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 INNDexpanthenol
    D.3.9.3Other descriptive nameDEXPANTHENOL
    D.3.9.4EV Substance CodeSUB07042MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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
    healthy volunteers; intended indication is the treatment of acute wounds such as abrasions, cuts, scratches, laceration, blistering burns and sunburns
    E.1.1.1Medical condition in easily understood language
    superficial wounds
    E.1.1.2Therapeutic area Not possible to specify
    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
    The primary objective will be the comparison of the investigational product versus untreated on the size of the open wound area/crusts assessed by image analysis at the different assessment time points (AUC over time on relative differences to baseline).
    E.2.2Secondary objectives of the trial
    • Comparisons of ref product vs inv product and vs untreated on size of open wound area/crusts
    • Pair-wise comparisons of the inv product, ref product and untreated area on relative differences to baseline of size of open wound area/crusts.
    • Comparisons of size of open wound area/crusts at each post-treatment assessment time point vs baseline each treatment separately.
    • Pair-wise comparisons of inv product, ref product and untreated area on wound margin area
    • Pair-wise comparisons of inv product, ref product and untreated area on wound margin area at each post-treatment assessment time point.
    • Pair-wise comparisons of inv product, ref product and untreated area on wound healing assessed by visual scoring
    • Descriptive statistics for visual assessment scores of inflammation/infection or allergy.
    • Descriptive statistics for discontinuations.
    • Descriptive statistics for quantity of product usage.
    • Documentation and analysis of safety parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and women
    • Age 18 to 55
    • Skin type I to III (according to Fitzpatrick et al., 1974)
    • Willingness to actively participate in the study and to come to the scheduled visits
    • Willingness to discontinue the application of leave-on cosmetics (e.g. creams, lotions) and to avoid the use of detergents (e.g. soaps) in the test area throughout the course of the study and 3 days before the start of study
    • Willingness to avoid hard physical exercises (with heavy sweating), sauna, swimming and bathing during the test phase
    • Willingness to avoid extensive artificial as well as natural UV light on the test areas during the whole course of the study and for at least 3 months after the end of study
    • Willingness to avoid contact of the test area with water during the time of patch application (careful showering)
    • Uniform skin color and no erythema or dark pigmentation in the test area
    • Signed written informed consent to participate in the study
    • Negative urine pregnancy test (in female subjects of child bearing potential)
    • Reliable methods of contraception which result in a low failure rate (i.e. less than 1% per year) for women of childbearing potential (implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomised partner)
    E.4Principal exclusion criteria
    • Active skin disease, moles, tattoos, strong pigmentation and hairy skin at the test area or scars in the test area that would influence the visual scoring
    • Psoriasis and/or Lichen ruber and/or atopic dermatitis
    • History of keloids and hypertrophic scars
    • History of plaster sensitivity
    • Intake of drugs interfering with the immune system (e.g. antiphlogistics, corticosteroids, immuno-suppressants, and antihistamines) within up to 30 days (depending on the kind of therapy) before the start of the study as well as during the study
    • Concomitant therapy with substances at doses affecting blood coagulation (e.g. acetylic acid, anticoagulants diuretics, thiazides) within up to 14 days prior to the start of the study as well as during the study
    • Topical treatment of the test areas with drugs (e.g. with corticosteroids, antibiotics, anti-inflammatory substances) within 14 days prior to the start of the study as well as during the study ( moisturizers and sun protection are allowed until 3 days prior)
    • Treatment (within up to 14 days prior to the start of the study as well as during the study) with medication of concomitant illnesses which might influence the study (e.g. diabetes, dysfunction of blood clotting)
    • Diabetes
    • Intensive UV-light exposure within two weeks before the start of the study as well as during the study at the test areas
    • Removal of axillary lymph nodes
    • Allergy to the ingredients of the test products
    • Pregnancy or lactation
    • Severe illness on account of which the subject should not participate in the study in the opinion of the investigator
    • Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing
    • Any history of drug addiction or alcoholism in the past 3 years
    • Infectious diseases
    • Subjects with expected poor compliance
    • If in the opinion of the investigator the subject should not participate in the study for any reason
    • Participation in a clinical trial within the last 30 days prior to the start of this study and during the study conduct
    • Employees of the study sites or of the Sponsor company
    • Subjects who are inmates in psychiatric wards, prison or state institutions
    • Subjects underlying any other restrictions due to the participation in other tests / test institutes
    E.5 End points
    E.5.1Primary end point(s)
    The size of the open wound area (including area covered with crusts) will be determined for defined time points by image analysis. The relative difference to baseline will be calculated. AUCs from first to last assessment time point will be calculated with trapezoid formula for the three treatments on these relative differences to baseline. Statistical analysis for the primary objective will be done on the AUC values.
    E.5.1.1Timepoint(s) of evaluation of this end point
    not applicable
    E.5.2Secondary end point(s)
    Relative differences to baseline for open wound areas (including area covered with crusts) and actual wound size assessed by image analysis.
    Original wound margin area ratio to baseline wound size and AUC for original wound margin area ratio to baseline wound size from first to last assessment time point calculated with trapezoid formula for the three treatments.
    Visual assessment of wound healing at several time points.
    Inflammation and allergy signs at all time points.
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    intra-individual comparison
    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
    untreated
    E.8.2.4Number of treatment arms in the trial1
    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 defined as the last visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days15
    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: 36
    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 Yes
    F.3.2Patients No
    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 state36
    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)
    Since only healthy subjects are enrolled in this trial, a treatment after trial termination is not foreseen. Except for the case that non-healing of wounds occurs the wounds have to be followed-up until the wound is healed
    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 Decision2014-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-17
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