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    Summary
    EudraCT Number:2005-002922-79
    Sponsor's Protocol Code Number:Vitiligo
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-04-27
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2005-002922-79
    A.3Full title of the trial
    Investigation of 0.1% tacrolimus ointment for the treatment of vitiligo patients
    A.3.2Name or abbreviated title of the trial where available
    Vitiligo
    A.4.1Sponsor's protocol code numberVitiligo
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAvemedica, s.r.o.
    B.1.3.4CountryCzech Republic
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameProtopic
    D.3.2Product code 27315
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTacrolimusum monohydricum
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Kožní onemocnění vitiligo
    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
    Získat data o účinnosti a bezpečnosti Tacrolimus 0.1 % masti při léčbě onemocnění vitiligo v oblasti obličeje a krku u dospělé populace pacientů
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Studie se mohou účastnit pacienti mužského i ženského pohlaví všech etnických skupin.
    U pacientů musí být potvrzená diagnóza onemocnění vitiligem.
    Dospělí pacienti, kteří jsou schopni pochopit účel a rizika tohoto klinického hodnocení poskytnou informovaný souhlas se svoji účastí na studii.
    Ženy, u kterých je možnost otěhotnění, se této studie mohou účastnit pouze za předpokladu, že v průběhu své účasti na studii a několika následujících týdnů po jejím ukončení budou užívat lékařsky přijatelnou bezpečnou metodu antikoncepce.
    Pacienti splňují následující wash-out kritéria:

    Předstudijní léčebné omezení Wash-out doba před dnem 1
    Povrchové kortikosteroidy 3 dny
    Systemické kortikosteroidy (pouze pro
    léčbu AD) 5 dnů
    Elidel (pimecrolimus 1%) krém 1 týden
    Jiné hodnocené léky 4 týdny
    Fotoléčba (UVA, UVB) 6 týdnů

    Pacient souhlasí, že v průběhu studie nebudou užívat žádné léky, které protokol studie zakazuje.
    E.4Principal exclusion criteria
    Pacient je postižen genetickou epidermální bariérou jako je např. Nethertonům syndrom nebo postižením celé kůže.
    Pacientka je těhotná nebo kojící.
    Pacient trpí zánětem postiženého místa (které se mělo ve studii léčit)
    U pacienta je známa přecitlivělost na makrolidy nebo na jinou látku v masťovém základu masti tacrolimus.
    Pacient se v současné době účastní jiného klinického zkoušení nebo uplynulo méně než 28 dnů od ukončení jeho účasti v jiném KH.
    Jakákoliv forma zneužívání léků (včetně alkoholové nebo drogové závislosti), psychiatrické onemocnění nebo podmínky, které dle názora zkoušejícího lékaře, může znemožnit komunikaci se zkoušejícím lékařem.
    Pacient je HIV pozitivní.
    E.5 End points
    E.5.1Primary end point(s)
    Účinnost léčby bude vyhodnocena statistickým zpracováním dat získaných měřením postižených oblastí. Posuzovány budou barevné snímky získané z baseline visity oproti snímkům z dalších návštěv. Měření stupně depigmentace bude zaneseno v CRF. Obrázky budou analyzovány dvěma nezávislými klinickými lékaři a pomocí morfometrického digitálního počítačového programu, který vyhodnotí procentuální nárůst pigmentace vitiligem zasažené oblasti.
    Bezpečnost použití přípravku budu posuzována na základě změn krevních testů ode dne 1. Dále budou hodnocena hlášení nežádoucích událostí.
    Účinnost léčby bude vyhodnocena statistickým zpracováním dat získaných měřením postižených oblastí. Posuzovány budou barevné snímky získané z návštěvy ve dni 1 oproti snímkům z dalších návštěv. Měření stupně depigmentace bude zaneseno v CRF. Obrázky budou analyzovány dvěma nezávislými klinickými lékaři a pomocí morfometrického digitálního počítačového programu, který vyhodnotí procentuální nárůst pigmentace vitiligem zasažené oblasti.

    Bezpečnost použití přípravku bude posuzována na základě změn krevních testů ode dne 1. Dále budou hodnocena hlášení nežádoucích událostí.
    Lék nebude aplikován dlouhodobě kontinuálně, bude aplikován pouze na postiženou plochu, a to ve slabé vrstvě. Pacienti budou instruováni nevystavovat ošetřené plochy slunečnímu záření, dbát hygieny (omývání rukou po aplikaci krému).
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    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 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.8.5The 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    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 days
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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 2006-04-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 50
    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 Decision2006-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
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