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    Summary
    EudraCT Number:2014-005593-11
    Sponsor's Protocol Code Number:DIA_AD/2015
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-13
    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 number2014-005593-11
    A.3Full title of the trial
    Diacerein for the treatment of atopic dermatitis
    Diacerein zur Behandlung von atopischer Dermatitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diacerein for the treatment of atopic dermatitis
    Diacerein zur Behandlung von atopischer Dermatitis
    A.3.2Name or abbreviated title of the trial where available
    Diacerein for AD
    Diacerein für AD
    A.4.1Sponsor's protocol code numberDIA_AD/2015
    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 SponsorUniversity Hospital of Dermatology, Paracelsus Medical University
    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 supportUniversity Clinics for Dermatology, Salzburg
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital for Dermatology
    B.5.2Functional name of contact pointScientific associate
    B.5.3 Address:
    B.5.3.1Street AddressMüllner Hauptstraße 48
    B.5.3.2Town/ citySalzburg
    B.5.3.3Post code5020
    B.5.3.4CountryAustria
    B.5.4Telephone number+4366244823001
    B.5.5Fax number+4366244823003
    B.5.6E-mailv.wally@salk.at
    D. IMP Identification
    D.IMP: 1
    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 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 nameDiacerein
    D.3.2Product code 13739-02-1
    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 INNDIACEREIN
    D.3.9.1CAS number 13739-02-1
    D.3.9.4EV Substance CodeSUB07060MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic dermatitis
    Atopische Dermatitis
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis
    Atopische Dermatitis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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
    Reduction of local pruritus by 4 points (according to analogue scale) within 4 weeks
    Reduktion des lokalen Juckreizes um 4 Punkte (lt. Analogskala) innerhalb von 4 Wochen.
    E.2.2Secondary objectives of the trial
    a. Improvement of the skin by 30% according to the modified SCORAD (scoring atopical dermatitis) assessment tool
    b. Improvement of life quality (questionnaires).
    c. Determination of Il-1ß levels in patient serum.
    a. Verbesserung des Hautbildes um 30% lt. modifiziertem SCORAD (scoring atopical dermatitis) Bewertungstool.
    b. Verbesserung der Lebensqualität. (Fragebogen)
    c. Ermittlung der IL-1ß Levels im Serum.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Minimum age of 18 years
    - Atopic dermatitis, mild to medium degree of severity (SCORAD < 50 points), with according diagnostic criteria after Hanifin and Rajka
    - Presence of lesional skin changes of mild to medium grade, characterized by the modified, local SCORAD (scoring atopic dermatitis) of at least 4 and confirmed by a qualified investigator.
    - Presence of mild to medium degree lesions on at least 3% of the body surface, suitable for topical therapy
    - signature patient informed consent
    • Mindestalter 18 Jahre
    • Atopische Dermatitis, leichte bis mittelschwere Form (SCORAD < 50 Punkte), mit zutreffenden Diagnosekriterien nach Hanifin und Rajka
    • Vorhandensein von läsionalen Hautveränderungen leichten bis mittelschweren Grades, charakterisiert durch den modifizierten lokalen SCORAD (Scoring atopic dermatitis) von mindestens 4, und bestätigt durch einen qualifizierten Investigator.
    • Vorhandensein einer Index/Zielläsion mittelschweren Grades von ca 3% der Körperobefläche, geeignet für die Anwendung topischer Therapie
    • unterzeichnete Einverständniserklärung
    E.4Principal exclusion criteria
    - Simultaneous participation in another clinical study
    - Known or suspected intolerances against diacerein, auxiliaries of the investigational product (especially tartrazine) or substances with similar structure.
    - Known or suspected intolerances against the cream base.
    - Pregnancy or lactation
    - Use of topic, anti-pruritic therapy of antibiotic therapy at the treated body areas, 7 days before the beginning of the trial.
    - Systemic therapy with known sedative or anti-pruretic effect 2 weeks before the beginning of the trial.
    - Topical application of Tacrolimus cream 0,03% or pimecrolimus cream 1% two weeks before the beginning of the trial on the treated body areas.
    - Phototherapy or systemic therapy with known effect on atopic dermatitis one month before the beginning of the trial.
    - Clinically super infected atopic dermatitis at the treated skin area.
    - Further skin diseases, apart from atopic dermatitis, at the treated skin areas like for example tinea corporis, intertriginous tinea, scabies, impetigo or chickenpox.
    - Other relevant diseases (acute infections,active tumors, ...)
    - Patients with severe hepatic impairment
    - immunosuppresed patients
    • Gleichzeitige Teilnahme an einer anderen klinischen Studie
    • Bekannte oder vermutete Unverträglichkeiten gegen Diacerein, Hilfsstoffe des Prüfpräparats (insbesondere Tartrazin) oder Substanzen mit ähnlicher Struktur.
    • Bekannte oder vermutete Unverträglichkeit gegen die Salbengrundlage (Ultraphil).
    • Anwendung von topischer juckreizstillender Therapie oder antibiotischer Therapie an den Behandlungsarealen 7 Tagen vor Beginn der Studie.
    • Anwendung von systemischer Therapie mit bekanntem sedativen oder juckreizmodulierenden Effekt 2 Wochen vor Beginn der Studie.
    • Topische Anwendung von Tacrolimus Salbe 0,03% oder Pimecrolimus Salbe 1% 2 Wochen vor Studienbeginn an den Behandlungsarealen.
    • Anwendung einer Phototherapie oder systemischen Therapie mit bekannter Auswirkung auf AD 1 Monat vor Studienbeginn.
    • Klinisch super infizierte AD an den Behandlungsarealen.
    • Weitere Hauterkrankung, neben AD, an den Behandlungsarealen wie u.A. Tinea corporis, intertriginöse Tinea, Scabies, Windpocken, Impetigo.
    • Schwangerschaft oder Stillzeit
    • Relevante andere Erkrankungen (akute Infektionen, aktive Tumorerkrankung …)
    • PatientInnen mit schweren Leberfunktionsstörungen
    • Immunsupprimierte Patienten
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of pruritus by 4 points according to analogue scale.
    Reduktion des Juckreizes um 4 Punkte laut Analogskala.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 4 weeks.
    Nach 4 Wochen
    E.5.2Secondary end point(s)
    - Improvement of the skin by 30% according to local SCORAD
    - Improvement of life quality (according to questionnaire).
    - Monitoring of systemic Diacerein and IL-1ß levels.
    • Verbesserung des Hautbildes um 30% laut lokalem SCORAD (scoring atopical dermatitis) Bewertungstool.
    • Verbesserung der Lebensqualität. (mittels Fragebogen)
    • Monitoring des systemischen Diacerein und IL-1ß Levels.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 4 weeks.
    Nach 4 Wochen.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 Yes
    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 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 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    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.1.2.1Number of subjects for this age range: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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.4.1In the member state10
    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)
    Usual care. Normal standard treatment.
    Usual care. Normale Standardbehandlung.
    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 Decision2015-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-20
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