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    Summary
    EudraCT Number:2012-000746-36
    Sponsor's Protocol Code Number:P-100797-01
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-03-28
    Trial 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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2012-000746-36
    A.3Full title of the trial
    A phase I open-label multiple dose study to examine the systemic bioavailability and safety of twice daily topical applications of ozenoxacin 1% cream formulation in patients with impetigo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the absorption and safety of an antibiotic cream administered twice daily in patients, including children, with an skin infection called impetigo.
    A.4.1Sponsor's protocol code numberP-100797-01
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/229/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFerrer Internacional, S.A.
    B.1.3.4CountrySpain
    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 supportFerrer Internacional, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFerrer Internacional, S.A.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressJuan de Sada, 32
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08028
    B.5.3.4CountrySpain
    B.5.4Telephone number34935093263
    B.5.5Fax number34936742500
    B.5.6E-mailclinicaltrials@ferrergrupo.com
    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 nameOzenoxacin
    D.3.2Product code GF-001001-00
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOzenoxacin
    D.3.9.1CAS number 245765-41-7
    D.3.9.2Current sponsor codeOzenoxacin
    D.3.9.3Other descriptive nameGF-001001-00
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Impetigo
    E.1.1.1Medical condition in easily understood language
    Skin infection
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10021531
    E.1.2Term Impetigo
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the systemic absorption of ozenoxacin 1% cream following repeated topical applications by analysing plasma ozenoxacin concentrations in patients with impetigo.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of ozenoxacin 1% cream after repeated topical applications in patients with impetigo.
    Clinical response at the end of therapy will also be evaluated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who meet the following criteria will be considered eligible to participate in the clinical study:
    1. Written informed consent.
    2. Males and females, 2 months to 65 years.
    3.Patients with a clinical diagnosis of non-bullous or bullous impetigo.
    4.The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area.
    5.Females of childbearing potential: negative urine pregnancy test.
    6.Females: surgically sterile for at least 6 months prior to first application of the IMP; pre-menarchial or postmenopausal women who are amenorrhoeic for at least 12 months; or if of childbearing potential, must in the opinion of the investigator, be using a suitable and effective contraceptive method during the study. Females must agree not to become pregnant during the period of IMP exposure.
    7.Treatment with the following agents prior to study drug administration (when applicable):
    -At least one week since last systemic oral antibiotic therapy or last topical antibiotic therapy.
    -At least 30 days since last long-acting injectable antibiotic.
    -At least 24 h since last topical therapeutic agent. -At least 8 h since last topical antiseptic or other treatment that in the investigator’s opinion could confound the evaluation of the treatment effect on the investigational area(s) applied directly to the impetigo lesions
    -At least 8 h since last administration of any systemic or topical anti-inflammatory, antihistamine or analgesic drug.
    E.4Principal exclusion criteria
    Patients who meet one or more of the following criteria will not be considered eligible to participate in the clinical study:
    1. A history of hypersensitivity to the IMP or any of the excipients or to medicinal products with similar chemical structures.
    2. Treatment with any other IMP in the last 12 weeks before administration of the first dose in this clinical study.
    3. Pregnant or lactating women.
    4. Received systemic or topical skin treatment with immunosuppressive agents within 21 days before dosing with the IMP.
    5. Current medical history of uncontrolled diabetes.
    6. A history of, or known current problems with, drug or alcohol abuse.
    7. Vulnerable patients (e.g., persons kept in detention).
    8. Any concurrent disease, condition or therapy that in the opinion of the Investigator would make the patient unsuitable for participation in the clinical study.
    9. Planned treatment with antibacterial medication (other than the IMP) during the study.
    10. Signs and symptoms of systemic infection.
    11. Presence of skin infection not amenable to topical treatment only.
    12. Have a history of or are currently being treated for active AIDS, hepatitis B or hepatitis C.
    E.5 End points
    E.5.1Primary end point(s)
    The systemic absorption following repeated topical applications of ozenoxacin 1% cream will be assessed, by analysing the plasma ozenoxacin concentrations.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ozenoxacin plasma concentrations will be assessed at visit 1 (Day 1), visit 2 (Day 2), visit 3 (Day 4) and visit 4 (Day 6) in all age subsets and additionally and only for paediatric subset aged 12 years to less than 18 years and adults, at visit 5 (Day 7).
    E.5.2Secondary end point(s)
    Safety:
    - Adverse events
    - Safety laboratory data
    - Vital signs
    - Physical exam
    - Treatment compliance

    Efficacy:
    - Clinical response
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety:

    - Adverse events, vital signs and physical exam: at visit 1 (Day), visit 2 (Day 2), visit 3 (Day 4) and visit 4 (Day 6) in all age subsets and additionally and only for paediatric subset aged 12 years to less than 18 years and adults, at visit 5 (Day 7).

    - Safety laboratory data: visit 1 (Day 1) for all age subsets and visit 4 (Day 6) for age subsets > 6 months only.

    - Treatment compliance: at visit 4 (Day 6).


    Efficacy:
    - Clinical response: at visit 4 (Day 6).
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Systemic absorption, safety and tolerability study in paediatric and adult patients with impetigo
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    South Africa
    E.8.7Trial has a data monitoring committee Yes
    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
    Last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 42
    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.1.1.4.1Number of subjects for this age range: 24
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 9
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 9
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 8
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 50
    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 subject has ended the participation in the trial, he/she will be treated according to the investigator criteria. Adverse events that are still present after the last patient´s schedule visit will be followed up 30 days by means of visit, phone call or any other, as considered appropiate.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation QdotPharma George
    G.4.3.4Network Country South Africa
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation QdotPharma Port Elizabeth
    G.4.3.4Network Country South Africa
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: South Africa
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