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    Summary
    EudraCT Number:2014-003479-52
    Sponsor's Protocol Code Number:NL50433.068.14
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-003479-52
    A.3Full title of the trial
    Surgical excision versus combined therapy with Curettage and Imiquimod for the treatment of Nodular Basal Cell Carcinoma: an open, non-inferiority, randomized controlled trial
    Chirurgische excisie versus gecombineerde behandeling met curettage en imiquimod voor de behandeling van het nodulair basaalcelcarcinoom: een open, niet-inferioriteit, gerandomiseerde gecontroleerde studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Surgical treatment versus partial debulking prior to cream treatment for skin cancer
    Operatieve verwijdering in vergelijking met partiele tumor verwijdering voorafgaand aan creme behandeling voor huidkanker
    A.3.2Name or abbreviated title of the trial where available
    S.C.I.N. Trial
    S.C.I.N. Trial
    A.4.1Sponsor's protocol code numberNL50433.068.14
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02242929
    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 SponsorMaastricht University Medical Centre
    B.1.3.4CountryNetherlands
    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 supportMEDA Pharma BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University Medical Centre
    B.5.2Functional name of contact pointKiki Frencken
    B.5.3 Address:
    B.5.3.1Street AddressP. Debyelaan 25
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6202 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031433877295
    B.5.5Fax number0031433877293
    B.5.6E-mailkiki.frencken@mumc.nl
    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 Aldara 5% cream
    D.2.1.1.2Name of the Marketing Authorisation holderMeda AB
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameImiquimod 5% cream
    D.3.4Pharmaceutical form Cream
    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 INNIMIQUIMOD
    D.3.9.1CAS number 99011-02-6
    D.3.9.4EV Substance CodeSUB12453MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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
    Histologically proven primary nodular basal cell carcinoma ≥ 4mm and ≤ 20mm in diameter outside the face and hairy scalp.
    Histologisch bevestigd primair nodulair basaalcelcarcinoom ≥ 4mm < 20mm in diameter buiten het gelaat en de behaarde hoofdhuid.
    E.1.1.1Medical condition in easily understood language
    Skincancer
    Huidkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10073093
    E.1.2Term Nodular basal cell carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare long-term efficacy of curettage prior to IMQ 5% cream (Aldara®) therapy versus standard surgical excision in primary nodular basal cell carcinoma.
    Het vergelijken van lange termijn effectiviteit van imiquimod 5% crème (Aldara), met voorafgaand curettage versus standaard chirurgische excisie bij primaire nodulaire basaalcelcarcinomen.
    E.2.2Secondary objectives of the trial
    To assess compliance, cosmetic outcomes, patient satisfaction, patient preference and cost-effectiveness.
    Het bepalen van compliance, cosmetiek, patienttevredenheid, patientvoorkeur en kosten-effectiviteit.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults aged 18 years or older
    - Primary histologically proven nodular basal cell carcinoma ≥ 4mm and ≤ 20mm in diameter
    - Patient is able to apply cream
    - Comorbidities may not interfere with study treatment (evaluated by investigator)
    - Capable to understand instructions
    - Volwassenen ouder dan 18 jaar
    - Primair histologisch bevestigd nodulair basaalcelcarcinoom ≥ 4mm en ≤ 20mm in diameter
    - Patient is in staat om creme aan te brengen
    - Comorbiditeiten mogen niet met studiemedicatie interfereren (geevalueerd door onderzoeker)
    - In staat instructies te begrijpen
    E.4Principal exclusion criteria
    - A nodular BCC located in the face or hairy scalp
    - Recurrent (previously treated) nBCC
    - Aggressive histopathologcial BCC subtypes
    - Life expectancy of less than five years
    - Breast-feeding or pregnant women
    - Serious comorbidities (evaluated by investigator)
    - Use of immunosuppressive medication during the trial period until 3 months after end of treatment or within 30 days before enrolment
    - Patients with genetic skin cancer disorders
    - Een nodulair BCC gelokaliseerd in het gezicht of de behaarde hoofdhuid
    - Recidief nodulair BCC (eerdere behandeling)
    - Agressieve histopathologische BCC subtypes
    - Levensverwachting van korter dan vijf jaar
    - Vrouwen die borstvoeding geven of zwanger zijn
    - Ernstige comorbiditeiten
    - Gebruik van immunosuppressive middelen tijdens de studie periode tot 3 maanden na het einde van de behandeling of 30 dagen voor start van de studie
    - Patiënten met genetische huidmaligniteiten syndromen
    E.5 End points
    E.5.1Primary end point(s)
    Proportion free of initial nBCC patients at one 1 year after end of treatment (defined as absence of initial treatment failure or any clinical signs of local recurrence).
    Proportie tumorvrije (initieel nBCC) patienten 1 jaar na het einde van de behandeling (gedefinieerd als afwezigheid van initieel behandelfalen of klinische tekenen van locaal recidief).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 1 year after end of treatment
    Op 1 jaar na het einde van de behandeling
    E.5.2Secondary end point(s)
    5-year cumulative probability of recurrence free survival after end of treatment, compliance, pain, cosmetic appearance, patient satisfaction, patient preference and cost-effectiveness.
    5-jaar cumulatieve waarschijnlijkheid van recidief vrije survival na het einde van de behandeling, compliance, pijn, cosmetisch resultaat, patienttevredenheid, patient voorkeur en kosten-effectiviteit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    5-year cumulative probability of recurrence free of initial BCC survival after end of treatment.

    Compliance in imiquimod group at week 6 in patient diary.

    Pain during treatment and two weeks after end of treatment.

    Cosmetic appearance and patient satisfaction after 1 and 5 years after end of treatment.

    Patient preference at start of treatment.

    Cost-effectiveness after 1 and 5 year follow-up.
    5-jaar cumulatieve waarschijnlijkheid van recidief vrije survival van het initiële BCC na het einde van de behandeling.

    Compliance in imiquimod groep in week 6 uit patiëntdagboekjes.

    Pijn tijdens de behandeling en twee weken na afloop van de behandeling.

    Cosmetisch resultaat en patienttevredenheid na 1 en 5 jaar na beëindiging van de behandeling.

    Patientvoorkeur aan het begin van de behandeling.

    Kosteneffectiviteit na 5 jaar follow-up.
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Niet-inferioriteit
    Non-inferiority
    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
    Standaard chirurgische excisie met 3-5 mm marge
    Standard surgical excision with 3-5 mm margin
    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
    The end of the trial will be the last visit of the last subject undergoing
    the trial.
    Het einde van de studie is als het laatste bezoek van de laatste
    proefpersoon die meedoet aan de studie heeft plaatsgevonden.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months3
    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: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state144
    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)
    After treatment patients will receive clinical follow-up visits at 3months (only patient in IMQ group), 1 year and 5 years after end of treatment. If there is clinical suspision of initial treatment failure or recurrent BCC, a 3 mm punch biopsy is taken for histological verification. In case of histological recurrence, retreatment will take place (surgical excision in both studyarms).
    Na behandeling krijgen patienten klinische follow-up visites na 3 maanden (alleen patienten in IMQ groep), 1 jaar en 5 jaar. In geval van klinische verdenking op initieel behandelfalen, zal er een 3mm biopt worden genomen, voor histopathologische bevestiging. Indien er sprake is van een histologisch bevestigd recidief, zal de plek opnieuw behandeld worden (chirurgische excisie in beide studiearmen).
    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 Clinical Trial Centre Maastricht
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
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