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    Summary
    EudraCT Number:2018-004685-33
    Sponsor's Protocol Code Number:NL67545
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-14
    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 number2018-004685-33
    A.3Full title of the trial
    Surgical excision versus photodynamic therapy and topical 5-fluorouracil in treatment of Bowen’s disease: a multicenter randomized controlled trial
    (Kosten)effectiviteit van chirurgische excisie versus photodynamische therapie en 5-fluorouracil crème bij morbus Bowen: een gerandomiseerde studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparing surgical excision with photodynamic therapy and 5-Fluorouracil in treatment of Bowen'disease.
    Vergelijking van operatieve verwijdering met photodynamische therapie (PDT) en 5-Fluorouracil crème (Efudix) als behandeling van de ziekte van Bowen
    A.3.2Name or abbreviated title of the trial where available
    BOWTIE
    BOWTIE
    A.4.1Sponsor's protocol code numberNL67545
    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 SponsorazM
    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 supportazM
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportzonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentrale Commissie Mensgebonden Onderzoek (CCMO)
    B.5.2Functional name of contact pointCCMO
    B.5.3 Address:
    B.5.3.1Street AddressParnassusplein 5
    B.5.3.2Town/ cityDen Haag
    B.5.3.3Post code2511 VX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031070340 6700
    B.5.6E-mailccmo@ccmo.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 Efudix
    D.2.1.1.2Name of the Marketing Authorisation holderMylan Healthcare B.V.
    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.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Topical use (Noncurrent)
    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.IMP: 2
    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 Metvix 160 mg/g crème
    D.2.1.1.2Name of the Marketing Authorisation holderGalderma Benelux B.V.
    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.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    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
    Bowens's disease
    Morbus Bowen
    E.1.1.1Medical condition in easily understood language
    Bowen's disease is a superficial form of skincancer.
    De ziekte van Bowen is een oppervlakkige vorm van huidkanker.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    To determine the (cost)effectiveness of 5-fluorouracil cream (5FU) and photodynamic therapy (PDT), compared to surgical excision (SE) in Bowen’s Disease (BD).
    Het doel is om de (kosten)effectiviteit van 5-fluorouracil cream (5FU) en photodynamische therapie (PDT), te vergelijken met chirurgische excisie in morbus Bowen.
    E.2.2Secondary objectives of the trial
    To compare the effectiveness of 5-fluorouracil cream (5FU) with that of photodynamic therapy (PDT) in Bowen’s Disease (BD).
    To examine if 5-fluorouracil cream (5FU) and photodynamic therapy (PDT) result in greater patient satisfaction and/or cosmetic result compared to surgical excision (SE) in Bowen’s Disease (BD).
    Om de (kosten)effectiviteit van 5-fluorouracil cream (5FU) te vergelijken met photodynamische therapie (PDT)in morbus Bowen.
    Onderzoeken of 5-fluorouracil (5FU) en photodynamische therapie (PDT) resulteert in meer patient tevredenheid en/of cosmetiek in vergelijking tot chirurgische excisie in morbus Bowen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Adults ≥ 18 years
    -Histologically proven primary Bowen’s disease
    -Lesions ≥ 4mm and ≤ 40mm in diameter
    -Fitzpatrick skin type I-IV
    -Female in child bearing potential should be using contraceptive measures, during and till 3 months post-treatment

    -Volwassenen≥ 18 jaar
    -Histologisch bewezen primaire morbus Bowen
    Lesies ≥ 4mm en ≤ 40mm in diameter
    -Fitzpatrick huid type I-IV
    -Vrouwen die zwanger kunnen worden moeten anticonceptie maatregelen nemen, tijdens en 3 maanden na behandeling
    E.4Principal exclusion criteria
    -Bowen's Disease located at ears, periocular, nail , nail unit or periungual tissue, nose (limited light exposure for PDT) and mucous membranes (different entities)
    -High clinical suspicion of invasive SCC
    -(N)MSC in target area
    -Breastfeeding
    -Pregnancy
    -Allergy to study drugs
    -Not able to self-apply cream on lesions located on the back or other difficult to reach locations
    -Genetic skin cancer disorders
    -Not understanding Dutch language
    -Porphyria
    -Not able to give informed consent
    -Immuno-compromised status
    -Use of systemic retinoid in the past 3 months
    -Use of immunosuppressant drugs in the past 3 months and / or at time of treatment (such as oral glucocorticoids, cytostatic, antibodies, drug acting on immunophilins, in-terferon, opioids, TNF binding proteins, MMF, biologic agents). inhalation corticoster-oids / nasal corticosteroids are permitted.
    -Locatie van M. Bowen op oren, perioculair, nagel/nagelbed, neus en slijmvliezen
    -Hoge klinische verdenking plaveiselcelcarcinoom
    -(N)MSC in gebied van behandeling
    -Borstvoeding
    -Zwangerschap
    -Allergie voor medicatie in de studie
    - Niet in staat om zelf crème aan te brengen op laesies op de rug of andere moeilijk te bereiken locaties
    -Genetische huidkanker syndroom
    -Geen begrip van Nederlandse taal
    -Porfyrie
    -Niet in staat om informed consent te geven
    -Immuun gecompromiteerde status
    -Gebruik van systemische retinoid in de afgelopen 3 maanden
    -Gebruik van immuunsuppresieve medicatie in 3 maanden voor de studie of tijdens studie
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with sustained clearance.
    Proportie van patienten met complete respons.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 3 and 12 months and 2-years and 5-years post treatment.
    3 en 12 maanden en 2 jaar en 5 jaar na behandeling.
    E.5.2Secondary end point(s)
    Cost-effectiveness, side effects, cosmetic outcome, patient satisfaction, patient preference and compliance.
    Kosten-effectiviteit, bijwerkingen, cosmetiek, patient tevredenheid, patient voorkeur en therapietrouw.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 3 and 12 months
    3 en 12 maanden
    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 No
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    chirurgische excisie
    Surgical excision
    E.8.2.4Number of treatment arms in the trial3
    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 concerned4
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 118
    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 state168
    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
    Geen
    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 Decision2019-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-01
    P. End of Trial
    P.End of Trial StatusOngoing
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