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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.
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    Summary
    EudraCT Number:2014-003216-37
    Sponsor's Protocol Code Number:n.a.
    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:2014-10-28
    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 number2014-003216-37
    A.3Full title of the trial
    Efficacy of Verapamil/ Verapamil-Kenacort injection versus Kenacort injection in Scar Treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of two different injections in scar treatment
    A.3.2Name or abbreviated title of the trial where available
    Verapamil vs Kenacort injection in Scar Treatment
    A.4.1Sponsor's protocol code numbern.a.
    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 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 Verapamil Hydrochloride
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm BV
    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 Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVerapamil
    D.3.9.1CAS number 99300-78-4
    D.3.9.3Other descriptive nameVERAPAMIL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB05088MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5
    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.IMP: 2
    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.2.1.1.1Trade name Triamcinolone Acetonide
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squib 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 Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIAMCINOLONE ACETONIDE
    D.3.9.1CAS number 76-25-5
    D.3.9.4EV Substance CodeSUB04936MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Hypertrophic and keloid scars are pathological scars as a result of dermal injury and exhibit exuberant, indefinite growth of collagen during wound healing. Hypertrophic and keloid scars often cause symptoms such as hypersensitivity, pruritus or pain. Patients are often affected with major cosmetic, psychological and social consequesnce.
    E.1.1.1Medical condition in easily understood language
    Hypertrophic and keloid scars are scars as a result of dermal injury and exhibit exuberant, indefinite growth of collagen during wound healing. They often cause hypersensitivity and pain.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    • Scar volume
    To objectively determine and compare the efficacy of Verapamil, Kenacort+Verapamil, and Kenacort injections.
    Using the Vectra XT 3D imaging system (Canfield Imaging Systems, Fairfield, NJ)
    E.2.2Secondary objectives of the trial
    • Patient and Observer Scar Assessment Scale (POSAS)
    To subjectively determine and compare the efficacy of Verapamil, Kenacort+Verapamil, and Kenacort injections.
    Using the POSAS form
    • Complications/Side effects
    To determine and compare complications/side effects of Verapamil, Kenacort-Verapamil, and Kenacort injections.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● Hypertrophic scar
    Definition: Excessive overgrowth of dense collagen tissue, often red, pink, or purple in
    appearance, at the site of a healed skin defect. It resembles a keloid but is usually
    temporary, most often regresses without treatment, and remains confined to the site
    of injury.( http://medical-dictionary.thefreedictionary.com/hypertrophic+scarring)
    ● Keloid scar
    Definition: A nodular, firm, often linear mass of hypertrophic thickish scar tissue,
    consisting of irregularly distributed bands of collagen; occurs in the dermis, usually
    after trauma, surgery, burn, or a severe cutaneous disease. (http://medical
    dictionary.thefreedictionary.com/keloid)
    ● ≥ 18 years old
    E.4Principal exclusion criteria
    ● Hypertrophic or keloid scar on ear and scalp
    ● Hypertrophic or keloid scar with a treatment history of radio-, brachy- or
    cryotherapy, or steroid- or other intralesional therapies
    ● Allergy or intolerance to corticosteroids or Verapamil
    ● Pregnancy
    E.5 End points
    E.5.1Primary end point(s)
    The main study endpoint is difference in volume of the hypertrophic or keloid scar. Volume will be measured by a three-dimensional volume measurement technique using the Vectra XT 3D imaging system (Canfield Imaging Systems, Fairfield, N.J.). The camera determines points in three dimensions by triangulating position of six colour digital cameras. A three-dimensional surface image is generated through the principle of passive stereo photogrammetry, where the texture of the skin is used to determine geometry.
    Volume measurement will be done using Mirror Analysis 3D software (Canfield Imaging Systems, Fairfield, N.J.). (
    E.5.1.1Timepoint(s) of evaluation of this end point
    Objective assessment will be done by using a validated three-dimensional measurement technique. Measurements will be carried out on all 7 appointments. These follow-up moments will take place on week 0, week 1, week 3, week 6, week 13, week 26 and week 52.
    E.5.2Secondary end point(s)
    The first secondary study endpoint is difference in POSAS score. The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically in a 10-point scale and make up a ‘Total Score’ of the Patient and Observer Scale. Observers rate vascularity, pigmentation, pliability, thickness, relief and surface area. The Patient Scale contains six questions applying to pain, itching, colour, pliability, thickness and relief. (See Appendix 2)
    The other secondary study endpoint is the occurrence of any complications/side effects. Known side effects for intralesional corticosteroids are atrophy, pain and changes in pigmentation.22 Side-effects for intralesional verapamil were not specified by previous studies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Subjective assessment will be done by filling out the validated Patient and Observer Scar Assessment Scale.
    measurements will be carried out on all 7 appointments. These follow-up moments will take place on week 0, week 1, week 3, week 6, week 13, week 26 and week 52.
    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) 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 45
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state45
    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
    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 Decision2014-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-12
    P. End of Trial
    P.End of Trial StatusOngoing
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