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    Summary
    EudraCT Number:2008-000036-41
    Sponsor's Protocol Code Number:IPTG-01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-21
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-000036-41
    A.3Full title of the trial
    An antimicrobial cream for the treatment of impetigo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the efficacy of an antimicrobial cream in the treatment of impetigo.
    A.3.2Name or abbreviated title of the trial where available
    IPTG-01: A new skin cream for impetigo
    A.4.1Sponsor's protocol code numberIPTG-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 SponsorDermal Laboratories Ltd
    B.1.3.4CountryUnited Kingdom
    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 organisationDermal Laboratories Ltd
    B.5.2Functional name of contact pointSue Dean
    B.5.3 Address:
    B.5.3.1Street AddressTatmore Place
    B.5.3.2Town/ cityGosmore, Hitchin
    B.5.3.3Post codeSG4 7QR
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01462 458866
    B.5.5Fax number01462 438707
    B.5.6E-mailclinical@dermal.co.uk
    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.2.1.1.1Trade name Impetus Cream
    D.2.1.1.2Name of the Marketing Authorisation holderDermal Laboratories Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameIPTG Cream
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Cutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLiquid Paraffin
    D.3.9.1CAS number 8012-95-1
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIsopropyl Myristate
    D.3.9.1CAS number 110-27-0
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBenzalkonium Chloride
    D.3.9.1CAS number 63449-41-2
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNChlorhexidine dihydrochloride
    D.3.9.1CAS number 3697-42-5
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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.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 Fucidin Cream
    D.2.1.1.2Name of the Marketing Authorisation holderLeo Laboratories Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameFucidin Cream
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Cutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFusidic Acid
    D.3.9.1CAS number 6990-06-3
    D.3.9.4EV Substance CodeAS6
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The condition to be studied is uncomplicated localised primary non-bullous impetigo, suitable for topical antibacterial therapy alone.
    E.1.1.1Medical condition in easily understood language
    Uncomplicated impetigo.
    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 20.0
    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
    The primary objective of the study is to determine whether the new antimicrobial cream is effective (i.e. better than placebo) in the treatment of primary non-bullous impetigo.

    If we can show that the new cream is effective in this indication, it may provide a good alternative treatment and help mitigate the emergent bacterial resistance issues, and stigma, associated with antibiotic usage.
    E.2.2Secondary objectives of the trial
    The secondary objective is to determine whether the new cream is as effective as Fucidin Cream (the active comparator) in this indication. A further objective is to obtain additional reassurance on the safety of the new cream in this indication.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    i. Male or female patients aged 18 months and over.

    ii. Diagnosis of uncomplicated, localised, primary non-bullous (crusted) impetigo considered, by the Investigator, suitable for treatment with topical antibacterial therapy only.

    iii. Patients presenting with at least 1, but no more than 10, discrete impetigo lesions.

    iv. Patients with a total surface area of impetigo involvement not exceeding 100 cm2 (in the case of patients aged 18 years and above) or not exceeding 2% of the total body surface area (in case of patients younger than 18 years).
    E.4Principal exclusion criteria
    i) Patients with a history of intolerance or skin sensitivity to any of the ingredients.

    ii) Patients with underlying skin disease or trauma with clinical evidence of secondary infection, or a bacterial skin infection that, in the Investigator’s opinion, is not suitable for treatment with topical antibacterial therapy only (e.g. diabetic foot infections, extensive cellulitis, furunculosis, or abscess).

    iii) Patients with signs and symptoms of systemic infection (e.g. fever with oral temperature above 38.3ºC).

    iv) Patients who have applied any topical therapeutic agent (including corticosteroids, antibacterials and antifungals) directly to the impetigo lesion(s) within 48 hours prior to study entry.

    v) Patients who have taken any systemic antibacterial or steroid/corticosteroid treatment within 48 hours prior to study entry.

    vi) Patients with systemic diseases which, in the opinion of the Investigator, may adversely influence their participation in the trial.

    vii) Patients who have received any unlicensed drug within the last 30 days or who are scheduled to receive an investigative drug other than the study medication during the period of the study.

    viii) Patients who are immunocompromised.

    ix) Female patients who are pregnant or lactating (although there are no particular safety concerns in these patient groups, it is generally inappropriate for them to participate in clinical trials without overriding justification. Negative pregnancy testing will not be necessary, and there are no safety concerns, as such, about female patients potentially conceiving while taking part in the study).

    x) Patients considered unable or unlikely to attend the necessary follow-up visits at day 8 (or day 9 or 10) and potentially day 15 (or day 16 or 17), which are not part of the standard clinical care.

    xi) Patients who, in the opinion of the Investigator, have impetigo lesions which may require being covered with gauze, bandages and/or nappies during treatment with the IMP.

    xii) Patients with another member of the household participating in the study during the same treatment period (this is to avoid possible mix up between assigned treatments).

    xiii) Employees of the Sponsor or the Investigators, or their immediate family members (partner, offspring, parents, siblings or sibling’s offspring).
    E.5 End points
    E.5.1Primary end point(s)
    The Primary Outcome of this trial will be the clinical response, i.e. success or failure (as defined below), as visually assessed by the Investigator or a delegated Nurse Practitioner considered suitably experienced by the Investigator, at the End of Treatment (EOT) visit (Visit 2).

    Clinical success is defined as:
    • a total absence of treated lesions, or
    • the treated lesions have become dry without crusts, with or without erythema, compared with appearance at baseline, or
    • the lesions show improvement (defined as a decrease in the size of the affected area, number of lesions, or both) so that no further antimicrobial therapy is deemed necessary by the Investigator.

    Clinical failure is defined as:
    • deterioration of condition, or
    • insufficient improvement (i.e. lesions remain crusted and / or have exudate leaving a yellow or honey coloured crust, or the lesion area(s) has increased from baseline, with or without an increase in the number of lesions), so that additional antimicrobial therapy is required.

    Also note that ‘clinical failure’ prior to the end of treatment will be carried forward to the EOT visit. For example, any patients who stop study treatment, withdraw from the study or use additional treatments prior to the end of their 7 day treatment period because of deterioration of their impetigo, will be considered to have a clinical response of ‘clinical failure’.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy evaluation will be after 7 days of treatment, on Day 8 (or on Day 9 or Day 10 when necessary to accommodate clinic/surgery opening times). However, in all cases the treatment will stop after 7 days.
    E.5.2Secondary end point(s)
    Patients with a clinical response of ‘clinical success’ at Visit 2 (End of Treatment) will be asked to return one week after terminating treatment for a Follow-Up visit (Visit 3). The secondary efficacy parameter will be the clinical response at this Follow-Up visit, using the following criteria:

    Clinical success at Follow-Up is defined as:
    • continued absence of the treated lesions, or
    • the treated lesions have become dry without crusts, with or without erythema, or
    • the lesions show improvement (as defined for EOT above).

    Clinical failure at Follow-Up is defined as:
    • any subject who was a Clinical Success at EOT but has a recurrence (at the same or distant site) or worsening of lesions, or
    • any subject who has a clinical outcome of ‘unable to determine’ (e.g. if they are lost to follow-up).

    For analysis, any ‘clinical failure’ at (or before) the EOT visit (Visit 2) will be carried forward to the Follow-Up visit (visit 3).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoint will be evaluated one week after the end of treatment, on Day 15 (or on Day 16 or Day 17 when necessary to accommodate clinic/surgery opening times).
    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) 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 No
    E.8.1.4Double blind Yes
    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.8.2.4Number of treatment arms in the trial2
    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 concerned40
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days31
    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: 162
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 31
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 100
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 31
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    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.3.3.6.1Details of subjects incapable of giving consent
    Children and infants aged 18 months to 15 years of age.
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Minors within the age range of 18 months to 15 years old.
    F.4 Planned number of subjects to be included
    F.4.1In the member state242
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 242
    F.4.2.2In the whole clinical trial 242
    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)
    Patients whose non-bullous impetigo has not improved/cured after 7 day treatment with the IMP, and patients whose non-bullous impetigo has recurred during the week after discontinuation of treatment, will be returned to normal clinical care and offered a suitable alternative treatment by the investigator (qualified GP), in line with standard practice / NICE recommendations or referred back to their own GP (if recruited from a PIC site or through adverts in the community).
    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 NIHR Primary Care Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-27
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