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    Summary
    EudraCT Number:2018-004494-27
    Sponsor's Protocol Code Number:5020DERM-2018
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2019-01-16
    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
    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 ConcernedAustria - BASG
    A.2EudraCT number2018-004494-27
    A.3Full title of the trial
    pilotstudy-
    efficacy of infectoscab 5% creme in patients with scabies
    Pilotstudie-
    Untersuchung zur Wirksamkeit von Infectoscab 5%® Creme bei Patienten mit Skabies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    pilotstudy-
    efficacy of infectoscab 5% creme in patients with scabies
    Pilotstudie-
    Untersuchung zur Wirksamkeit von Infectoscab 5%® Creme bei Patienten mit Skabies
    A.3.2Name or abbreviated title of the trial where available
    pilotstudy- efficacy of infectoscab 5% creme in patients with scabies
    Pilotstudie- Untersuchung zur Wirksamkeit von Infectoscab 5%® Creme bei Patienten mit Skabies
    A.4.1Sponsor's protocol code number5020DERM-2018
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN12345678
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT12345678
    A.5.3WHO Universal Trial Reference Number (UTRN)U1234-1234-1234
    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 SponsorLandeskrankenhaus Salzburg
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLandeskrankenhaus Salzburg-PMU
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLandeskrankenhaus Salzburg
    B.5.2Functional name of contact pointUniversitäts-Hautklinik Salzburg
    B.5.3 Address:
    B.5.3.1Street AddressMüllner Hauptstr. 48
    B.5.3.2Town/ citySalzburg
    B.5.3.3Post code5020
    B.5.3.4CountryAustria
    B.5.4Telephone number+435725558673
    B.5.5Fax number+435725524799
    B.5.6E-maild.meyersburg@gmx.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 Infectoscab 5% Creme
    D.2.1.1.2Name of the Marketing Authorisation holderInfectopharm
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameInfectoscab 5% Creme
    D.3.4Pharmaceutical form Cutaneous emulsion
    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 INNPermethrin
    D.3.9.1CAS number 52645-53-1
    D.3.9.2Current sponsor coden.a.
    D.3.9.3Other descriptive namePERMETHRIN
    D.3.9.4EV Substance CodeSUB09734MIG
    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
    Scabies
    Skabies
    E.1.1.1Medical condition in easily understood language
    Scabies
    Skabies
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10039511
    E.1.2Term Scabies
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10063409
    E.1.2Term Acarodermatitis
    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
    Increasing numer of patients with scabies. Decreasing respond to Infectoscab 5% Creme.
    Zunehmende Patientenzahlen mit Skabies-Infektion. Abnehmendes Ansprechen auf Infectoscab 5% Creme.
    E.2.2Secondary objectives of the trial
    not applicable
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    light-microscope confirmed scabies
    - ages ≥6 years (when parents are treating)
    - auflichtmikroskopisch nachgewiesene Skabies
    - Alter ≥6 Jahre, sofern die Behandlung durch ein Elternteil stattfindet
    E.4Principal exclusion criteria
    Scabies norvegica/crustosa
    use of Infectoscab 5% creme in the past 4 weeks or multiple application without response in the last 6 months.
    unse of ivermectin orally in the past 3 months
    sensitivity/allergy against Infectoscab 5% creme (e.g. Permethrin, Cetylstearylalkohol (Typ A) or Sorbinsäure)
    pregnancy or breast-feeding woman
    mental retardation, alcohol abuse or non-compliance
    Skabies norvegica/crustosa
    - Anwendung von Permethrin-haltigen Cremes (z.B. Infectoscab 5% Creme®) in den letzten 4 Wochen oder mehrmalige (≥2x à 2 Applikationen) Anwendungsfrequenz Permethrin-haltigen Cremes ohne berichtete nachfolgende Abheilung in den letzten 6 Monaten.
    - Anwendung von Ivermectin oral in den letzten 3 Monaten.
    - bekannte Überempfindlichkeit gegen den Wirkstoff Permethrin oder den Emulgator Cetylstearylalkohol (Typ A) oder Sorbinsäure
    - Patienten, die aufgrund ihrer körperlichen Entwicklung oder ihrer klinischen Verfassung nicht in der Lage sind, die Behandlung zu verstehen und durchzuführen
    - Schwangerschaft und Stillzeit
    - Alkoholabusus, mentale Dysfunktion oder andere Faktoren, die zu mangelnder Zusammenarbeit führen können
    E.5 End points
    E.5.1Primary end point(s)
    Therapy with Infectoscab 5% Creme (days 0 and 7 whole body) has a failure rate of >30%
    Die Therapie mit Infectoscab® Creme in der konventionellen Anwendung (Tag 0+7 Ganzkörper) ist in >30% der Fälle nicht wirksam.

    E.5.1.1Timepoint(s) of evaluation of this end point
    3-5 weeks
    3-5 Wochen
    E.5.2Secondary end point(s)
    additional application of Infrectoscab 5% Creme at primary affected regions (e.g. hands, feet, genitals) for 7 consequtive days can lead to a higher curing rate.
    Die zusätzliche Behandlung der primär betroffenen Regionen (Hände und/oder Genitalregion und/oder Füße) an 7 aufeinander folgenden Tagen kann zu einer verbesserten Abheilungsrate führen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3-5 weeks
    3-5 Wocheen
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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 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 Yes
    E.8.2.3.1Comparator description
    Infectoscab 5% Creme
    Infectoscab 5% Creme
    E.8.2.4Number of treatment arms in the trial2
    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
    withdrawal of informed consent
    - pregancy
    -not tolerable AE
    - states manecing the health of the patients.
    - Rücknahme der Einwilligung des Patienten
    - Eintritt der Schwangerschaft
    - Nicht tolerierbare, unerwünschte Ereignisse
    - Andere Umstände, welche die Gesundheit des Probanden gefährden würden, wenn er weiterhin an der Studie teilnehmen würde
    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
    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: 3
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 1
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 2019-01-16. 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 No
    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)
    none
    keine
    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 Decision2019-02-08
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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