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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42330   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2012-002675-34
    Sponsor's Protocol Code Number:NL40235.078.12
    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:2012-06-29
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-002675-34
    A.3Full title of the trial
    Surgical and aesthetic outcome, quality of life, and cost-effectiveness of keloid treatment
    Chirurgische en aesthetische resultaten, kwaliteit van leven en kosteneffectiviteit van keloïdbehandeling
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Keloid (scar) treatment assesment
    Beoordeling van keloid (litteken) behandeling
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberNL40235.078.12
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 Yes
    D. of the Marketing Authorisation holderEuro Registratie Collectief B.V., Krimpen a/d IJssel, Nederland
    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 nameKenacort A'40'
    D.3.2Product code RVG05341
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E.1.1.1Medical condition in easily understood language
    Excessive scar tissue
    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
    Keloid disease is a tumorous scar that grows outside of wound borders. It appears as a raised, discoloured lesion that gives rise to aesthetic and psychosocial complaints, itching, and pain. Adequate treatment is indicated, but because of variable results and recurrence of the keloid current therapies are suboptimal.
    The Objective of the study is to find an effective and permanent treatment against keloid, by comparing current treatments on objective and subjective outcome.
    We will do this by a randomized controlled intervention study consistent of 2 parts, in oreder to remain close to clinical practice;
    1) for primary keloids comparing intralesional cryotherapy with excision combined with corticosteroid injections
    2) for recurrent keloids comparing intralesional cryotherapy with excision combined with brachytherapy
    This results in a total of 4 study arms; 2 in both parts of the study.
    Primary endpoint is Patient Observer Scar Assesment Scale (POSAS) score.
    Keloïd is een pathologisch litteken dat buiten wondgrenzen doorgroeit. Hierdoor ontstaat een gekleurde zwelling die naast esthetische en psychosociale klachten ook jeukt en pijnlijk is. Adequate behandeling is geïndiceerd, huidige behandelingen zijn suboptimaal door wisselende resultaten en recidieven.
    Doel van dit onderzoek is het vinden van de beste behandeling tegen keloïd, door huidige behandelingen te vergelijken op objectieve en subjectieve uitkomstmaten. Dit doen we door een gerandomiseerde interventie studie met 2 onderdelen, op basis van de klinische praktijk voor;
    1) primaire keloïden wordt intralesionale cryotherapie vergeleken met excisie en aanvullende corticosteroïd injecties.
    2) resistente keloïden wordt intralesionale cryotherapie vergeleken met excisie en aanvullend brachytherapie.
    Hiermee ontstaan er 4 armen binnen het onderzoek, 2 in ieder onderdeel.
    De primaire uitkomstmaat is de Patient Observer Scar Assesment Scale (POSAS) score.
    E.2.2Secondary objectives of the trial
    Secondary endpoints are volume reduction, Skindex-29, SF-36, ED-5Q, QST, histology,appearance of adverse reactions, and indication for further treatment.
    Secondaire uitkomstmaten zijn volumereductie, Skindex-29 score, SF-36 score, ED-5Q, QST, histologische veranderingen, het optreden van bijwerkingen en indicatie voor aanvullende behandeling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Keloid patients, 18-75 yr old, full mental competence, sufficient knowledge of Dutch or English language, keloid suitable for primairy closure after excision, minimum keloid size of 1x1cm.
    keloïd patienten, 18-75 jaar oud, wilsbekwaam, goede beheersing Nederlandse of Engelse taal, keloïd geschikt voor excisie in 1 tempo, minimale grootte van het keloïd 1x1 cm.
    E.4Principal exclusion criteria
    Hypertrofic scars. Keloids less than 1 year existent, burn scars, pregnancy, previous radiotherapy which prohibits additional rediotherapy (only for the group of recurrent keloids), hypersensitivity for lidocaine, adrenaline, triamcinolone. Chronic use (>1 month) of systemic corticosteroids, or immunosuppressive medication (e.g. TNF alfa inhibitors). Use of systemic chemotherapy. Severe morbidity with a life expectancy of less than one year.
    Hypertrofische littekens. Keloïden minder dan 1 jaar oud, Brandwondlittekens, Zwangerschap, Eerder ontvangen maximale dosis radiotherapie (voor de groep resistente keloïden), Overgevoeligheid voor lidocaine, adrenaline, triamcinolon. Langdurig (>1maand) gebruik van systemische corticosteroiden, of immunocompressiva (bv. TNF alfa remmers). Gebruik van sytemische chemotherapeutica.
    Ernstige morbiditeit met een levensverwachting van minder dan 1 jaar
    E.5 End points
    E.5.1Primary end point(s)
    POSAS score
    POSAS score
    E.5.1.1Timepoint(s) of evaluation of this end point
    before treatment, 2 weeks, 12 weeks, 26 weeks and 52 weeks after treatment
    Voor behandeling, 2 weken, 12 weken, 26 weken en 52 weken na behandeling.
    E.5.2Secondary end point(s)
    Secondary endpoints are volume reduction, Skindex-29, SF-36, ED-5Q, QST, histology, appearance of adverse reactions and indication for further treatment.
    Secondaire uitkomstmaten zijn volumereductie, Skindex-29 score, SF-36 score, ED-5Q, QST, histologische veranderingen, het optreden van bijwerkingen en indicatie voor aanvullende behandeling.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Volume, skindex-29, SF-36, EQ-5D, adverse reactions: Before treatment, 2 weeks, 12 weeks, 26 weeks and 52 weeks after treatment
    QST, indication for further treatment and Histology: before treatment en 26 weeks after treatment.
    Volume, skindex-29, SF-36, EQ-5D en optreden van bijwerkingen: Voor behandeling, 2 weken, 12 weken, 26 weken en 52 weken na behandeling.
    QST, indicatie voor aanvullende behandeling en histologische veranderingen: voor behandeling en 26 weken na behandeling.
    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. 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 Yes
    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 Yes
    E. description
    Intralesionale cryotherapie en excisie met brachytherapie
    Intralesional cryotherapy and Excision with brachytherapy
    E.8.2.4Number of treatment arms in the trial4
    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
    Laaste controle van laatst geincludeerde patient
    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: 166
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 2012-06-29. Yes
    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 state176
    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)
    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 Decision2012-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-12
    P. End of Trial
    P.End of Trial StatusOngoing
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