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    Summary
    EudraCT Number:2012-003954-95
    Sponsor's Protocol Code Number:E550-PRU-2012
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-04
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-003954-95
    A.3Full title of the trial
    Prospective, randomized, double-blind, placebo-controlled, clinical trial to explore the anti-pruritic effect, the safety and local tolerability of a topical Sertaconazol cream 2% in patients with atopic dermatitis.
    Prospektive, randomisierte, doppelblinde, plazebo-kontrollierte, klinische Prüfung zum Nachweis der anti-pruriginösen Wirksamkeit, der Sicherheit und der lokalen Verträglichkeit einer 2%igen Sertaconazol-Crème bei Patienten mit atopischer Dermatitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective clinical trial, in which the test product (a cream containing 2% of Sertaconazol a known anti-mycotic ingredient) or the comparator product (cream without any active ingredient) are being dispatched randomly to the patients without that they or their physicians know which product they receive. Objective is to explore the anti-itch potential of the test product in atopic dermatitis as well as its safety and its local tolerability.
    Prospektive klinische Studie bei welcher das Testprodukt (Crème mit 2% Sertaconazol einem bekannten Wirkstoff gegen Pilzinfekte) oder das Vergleichsprodukt (Crème ohne Wirkstoff) zufallsweise den Patienten abgegeben werden und ohne dass sie oder ihr Arzt wissen welches Produkt sie bekommen haben. Ziel der Studie ist es die Juckreitzstillende Wirkung des Testproduktes sowie seine Sicherheit und seine lokale Verträglichkeit bei Patienten mit atopischer Dermatitis nachzuweisen.
    A.4.1Sponsor's protocol code numberE550-PRU-2012
    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 SponsorSpirig Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportSpirig Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSpirig Pharma AG
    B.5.2Functional name of contact pointClinical Trials and Vigilance
    B.5.3 Address:
    B.5.3.1Street AddressFroschackerstrasse 6
    B.5.3.2Town/ cityEgerkingen
    B.5.3.3Post code4622
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41623878869
    B.5.5Fax number+41623878822
    B.5.6E-mailmacheynar.ramos@spirig.ch
    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 Mykosert Cream
    D.2.1.1.2Name of the Marketing Authorisation holderDr. R. Pfleger GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    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 placeboCutaneous use
    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 is an inflammatory, chronically relapsing, non-contagious and itchy skin disorder, known also as eczema.
    Atopische Dermatitis oder Atopisches Ekzem ist eine chronische, nicht ansteckende Hautkrankheit. Eine weitere Bezeichnung ist endogenes Ekzem.
    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
    Main objective of the study is to explore the efficacy of a topical Sertaconazol cream 2% for prutitus in patients with atopic dermatitis in a non-acute, stable phase in comparision to pla-cebo.
    Ziel der klinischen Prüfung ist es, eine Verminderung des Pruritus bei Patienten mit atopischer Dermatitis im nicht akuten Schub nach Anwendung der 2%igen Sertaconazol-Crème (im Vergleich zu Plazebo) zu belegen.
    E.2.2Secondary objectives of the trial
    Safety, and tolerability of the treatment.
    Sicherheit und Verträglichkeit der Therapie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - SCORAD (Severity SCORing of Atopic Dermatitis) ≤40 at inclusion
    - Male or female (nonpregnant, nonlactating, using contra-ception)
    - ≥ 18 years or ≤ 75.
    - Atopic lesions: Arms. Additional: Legs, Neck (areas to be evaluated: arms)
    - Chronic pruritus, persisting for at least 6 weeks before study start
    - At the 2 days before Visit 1 Pruritus ≥ 7 (VAS 0-10)
    - At Visit 1 pruritus intensitiy ≥ 3 (PGA questionnaire of the 5-point Likert Scale)
    - Signed informed consent after patient information
    - Agreement to discontinue for the duration of the trial the use of all current moisturizers and to replace them by a standard bland moisturizer given for all patients: Excipial Hy-drocrème
    - Willing and able to participate in the trial as an outpatient and to comply with all trial requirements
    • SCORAD (Severity SCORing of Atopic Dermatitis) ≤40 beim Einschluss
    • Geschlecht männlich oder weiblich (nicht schwanger / nicht stillende Frauen; Kontrazeption vorhanden)
    • Zwischen 18 und 75 Jahre alt
    • Atopische Läsionen: Arme; Beine, Hals (zu beurteilende Hautstelle: Arme)
    • Chronischer Pruritus, das heißt der Patient muss seit mindestens 6 Wochen einen Pruritus aufweisen
    • In den letzten 2 Tagen vor Visite 1 muss die Pruritus Intensität ≥ 7 sein (gemessen auf einer VAS 0-10)
    • Zum Zeitpunkt der Visite 1 muss für den Juckreiz (im PGA-Fragebogen der 5-Punkte Likert Skala) ein Wert ≥ 3 bestehen
    • Schriftliche Einverständniserklärung nach Aufklärung
    • Einverständnis, die bisher verwendeten hydratisierenden Pflegecrèmes abzusetzen und durch eine Standardcrème (Excipial Hydrocrème) zu ersetzen
    • Bereitschaft die mit der Prüfung einhergehenden Verpflichtungen zu erfüllen und die Anweisungen der Prüfärzte genau zu befolgen
    E.4Principal exclusion criteria
    - SCORAD at inclusion >40
    - Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g. cardiovascular, immunosuppressive, hematologic, hepatic, neurologic, renal, en-docrine, collagen-vascular, urogenital, gastro-intestinal abnormalities or diseases)
    - Evidence of an active systemic or dermatological infection
    - Evidence of immunosuppression or cancer
    - Alcohol- or drug abuse as assessed by the investigator
    - Participation in an other clinical study within a month of trial entry
    - Dermatological abnormalities, diseases or conditions in the treatment or surrounding areas that might be exacerbated by treatment with 2% Sertaconazol Cream or impair trial assessments as assessed by the investigator
    - Allergy or hypersensibility to any of the trial creams ingredients
    - Treatments before and during the trial:
    o Topical or systemic anti-histaminic drugs within 2 weeks before trial start
    o Systemic corticosteroids or high-dosed topical corticosteroids within 4 weeks before trial entry.
    o lmmunomodulatory or cytotoxic treatments within 4 weeks before trial start.
    o Naltrexon, antidepressants (like Paroxetin, Gabapentin, Pregabalin- if admitted because of their antipruritic effect) within 4 weeks before trial start.
    o Ciclosporin A and other Immunosuppressive drugs within 8 weeks before trial start,
    o Topical calcineurin inhibitors, topical antibiotics, antiseptic baths and washes within 8 weeks before trial start.
    - For female patients: pregnancy and lactation
    • SCORAD >40
    • Deutlich instabiler oder unkontrollierter medizinischer Zustand, durch den Prüfarzt bestimmt (z.B. kardiovaskuläre, immunologische, haematologische, hepatische, neurologische, endokrine, gastrointestinale, urogenitale, das Bindegewebe betreffende Störungen oder Krankheiten, Vorhandensein einer aktiven systemischen oder dermatologischen Infektion
    • Vorhandensein einer aktiven systemischen oder dermatologischen Infektion, Immunsuppression oder Krebs
    • Drogen- oder Alkohol-Abhängigkeit, durch den Prüfarzt bestimmt
    • Teilnahme an einer anderen klinischen Prüfung innerhalb eines Monats vor Einschluss in diese Untersuchung
    • Dermatologische Störungen, Erkrankungen oder Leiden an oder unmittelbar um die zu behandelnden Bereiche, die durch die Anwendung der 2%igen Sertaconazol-Crème verschlimmert werden oder die mit der Auswertung der Prüfergebnisse interferieren könnten
    • Bekannte Allergie oder Empfindlichkeit gegen eine oder mehrere Komponenten der Testpräparate
    • Behandlungen (Absetzungsfristen) vor oder während der Prüfung mit folgenden Präparaten
    - Topische oder systemische Antihistaminika innerhalb 2 Wochen vor Beginn der Prüfung
    - Systemische Kortikoide oder topische Anwendung von hochdosierten Kortikoiden innerhalb 4 Wochen vor Beginn der Prüfung
    - Immunomodulierende oder zytotoxische Behandlung innerhalb 4 Wochen vor Beginn der Prüfung
    - Naltrexon, Antidepressiva (wie z.B. Paroxetin, Gabapentin, Pregabalin – sofern wegen ihrer anti-pruritischen Wirkung verschrieben] innerhalb 4 Wochen vor Beginn der Prüfung
    - Cyclosporin A und andere Immunosuppressiva innerhalb 8 Wochen vor Beginn der Prüfung
    - Topische Calcineurin-Inhibitoren, topische Antibiotika, antiseptische Bäder und Waschlotionen innerhalb 8 Wochen vor Beginn der Prüfung
    • Bei weiblichen Patienten: Schwangerschaft oder Stillzeit
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy against pruritus, measured on the itch item of the 5-point Likert Scale in the PGA question-naire.
    • Wirksamkeit gegen Pruritus, gemessen am Item Juckreiz der 5-Punkte Likert-Skala im PGA-Fragebogen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1 (day 1), Visit 2 (day 14± 3), Visit 3 (day 28 ± 3), Visit 4 (day 42 ± 3)
    Visite 1 (Tag 1), Visite 2 (Tag 14± 3), Visite 3 (Tag 28 ± 3), Visite 4 (Tag 42 ± 3)
    E.5.2Secondary end point(s)
    Efficacy
    Intensitiy of pruritus determined by a visual analogue scale (VAS)
    EASI
    DLQI
    PBI
    PGA

    Safety and tolerability
    Recording of AE, SAE, ADR
    Local tolarability
    Systemic tolerability:
    Blood chemistry (alkaline phosphatase, bilirubin, GOT, GPT, serum creatinine)
    Vital signs
    • Wirksamkeit (Vor- und Nachvergleiche):
    - Pruritus-Intensität, mit einer visuellen Analogskala (VAS) bestimmt;
    - EASI (“Eczema Area and Severity Index”)
    - Lebensqualitätsindex DLQI (“Dermatological Life Quality Index”)
    - Patientennutzen PBI (”Patient Benefit Index”)
    - Globale Bewertung durch den Patienten PGA („Patient Global Assessment“)
    • Sicherheit und Verträglichkeit:
    - Erfassen der unerwünschten Ereignisse (UE), der schwerwiegenden unerwünschten Ereignisse (SUE), und der unerwünschten Arzneimittelwirkungen (UAW)
    - Lokale Verträglichkeit
    - Systemische Sicherheit:
    o Laborparameter (Alkalische Phosphatase; Bilirubin; GOT; GPT; Serum Creatinin)
    o Vitalparameter
    E.5.2.1Timepoint(s) of evaluation of this end point
    PGA:Visit 1, Visit 2, Visit 3, Visit 4
    SCORAD, EASI: Visit 1, Visit 3 and Visit 4
    VAS: V1, V2, V3, V4
    DLQI: V1, V3, V4
    PBI: V1, V3
    Recording of adverse events: V2, V3, V4
    Blood chemisstriy: V1, V3
    Vital signs: V1, V2, V3, V4
    PGA:Visite 1, Visite 2, Visite 3, Visite 4
    SCORAD, EASI: Visite 1, Visite 3 and Visite 4
    VAS: V1, V2, V3, V4
    DLQI: V1, V3, V4
    PBI: V1, V3
    Erfassung von UE, SUE und UAW: V2, V3, V4
    Laborparameter: V1, V3
    Vitalparameter: V1, V2, V3, V4
    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 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) 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 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 concerned2
    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
    Letzter Patient / Letzte Visite
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    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 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state80
    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)
    The follow up treatment after the end of the study is if necessary a dermatological, guideline compliant, topical and/or systemic therapy as clinically indicated. The treatment scheme is issued by a trained dermatologist.
    Nach dem Ende der klinischen Prüfung werden die Patienten soweit angezeigt mit einer dermatologischen, Leitlinien-konformen, topischen und/oder systemischen Therapie entsprechend dem klinischen Befund weiterbehandelt. Der Therapieplan wird von einem Dermatologen erstellt.
    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 Decision2012-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-17
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