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    The EU Clinical Trials Register currently displays   42567   clinical trials with a EudraCT protocol, of which   7008   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2011-003144-50
    Sponsor's Protocol Code Number:V00400GL2011A
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-09
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2011-003144-50
    A.3Full title of the trial
    A randomised, double blind, controlled, multicentre study in infants with infantile hemangioma to compare propranolol gel to placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in infants with infantile hemangioma to compare propranolol gel to placebo.
    A.4.1Sponsor's protocol code numberV00400GL2011A
    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 SponsorPierre Fabre Dermatologie, Represented by Institut de Recherche Pierre Fabre
    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 supportPIERRE FABRE DERMATOLOGIE
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recherche Pierre Fabre
    B.5.2Functional name of contact pointClinical Study Manager
    B.5.3 Address:
    B.5.3.1Street Address45 place Abel Gance
    B.5.3.2Town/ cityBOULOGNE
    B.5.3.3Post code92100
    B.5.4Telephone number33-(0) 5 34 50 63 60-
    B.5.5Fax number33-(0) 5 34 50 65 92-
    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 No
    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.3.2Product code V0400GL01A
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 318-98-9
    D.3.9.2Current sponsor codeV0400
    D.3.9.4EV Substance CodeSUB04091MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    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 placeboGel
    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
    Proliferating localised uncomplicated infantile hemangioma not requiring systemic therapy
    E.1.1.1Medical condition in easily understood language
    Proliferating localised uncomplicated infantile hemangioma
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10019400
    E.1.2Term Hemangioma of skin and subcutaneous tissue
    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 assess propranolol gel efficacy in terms of complete/nearly complete resolution of the Infantile Hemangioma at W12 compared to baseline.

    E.2.2Secondary objectives of the trial
    Efficacy objectives:
    To assess propranolol gel efficacy in terms of complete/nearly complete resolution of the IH at W4, W8 and Week 24 compared to baseline
    To evaluate the parent(s) or guardian(s) on-site qualitative assessments
    To assess the persistence of efficacy 12 weeksafter the end of treatment.

    Safety objective:
    To assess the safety profile and the local tolerance of the propranolol gel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible if he/she meets all of the following criteria:
    • Written informed consent(s) for study participation and the use of the patient’s images are obtained according to national regulations from the patient’s parent(s) or legal guardian(s) prior to performing any study procedures.
    • The patient is 35 to 150 days old inclusive, at inclusion.
    • Only one proliferating IH is present anywhere on the body except on the head, the neck, the hands and on the diaper area, with largest diameter ≥ 1cm and ≤ 5 cm.
    • If required by national regulations, patient registered with a social security or health insurance system and/or whose parent(s) or legal guardian(s) is (are) registered with a social security or health insurance system.
    E.4Principal exclusion criteria
    A patient will be ineligible if he/she meets any of the following criteria:
    • The patient has got more than one IH with largest diameter ≥ 1cm
    • The patient has a medically unstable health status that may interfere with his/her ability to complete the study.
    • IH requires, according to Investigator’s judgment, a systemic treatment.
    • The patient is known to have one or more of the following medical conditions: bronchial asthma; bronchospasm; hypoglycaemia; untreated phaeochromocytoma; hypotension; second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia; severe peripheral arterial circulatory disturbances; Raynaud’s phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal’s angina.
    • The patient has received at least one of the following prohibited medications within 14 days before randomisation:
    - Cardiovascular treatments: anti-arrhythmics, calcium channel blockers, ACE inhibitors, inotropic agents, vasodilators (hydralazine hydrochloride…), clonidine…
    - Hypoglycaemic agents or drugs able to induce hypoglycaemia.
    - Non-steroid anti-inflammatory drugs (NSAIDs) at anti-inflammatory dose.
    - Sympathomimetic agents and parenteral adrenaline.
    - Anaesthetic agents, lidocaïne (the prohibition period is shortened to 48 hours, if anaesthesia has been performed for diagnosis investigation e.g. MRI…)
    - Inducers of hepatic drug metabolism or substrates or inhibitors of CYP2D6, CYP1A2, CYP2C19
    - Anti-ulcer drugs (cimetidine, ranitidine, proton pomp inhibitors other than omeprazole and lanzoprazole)
    - Metoclopramide
    - Benzodiazepines
    - Neuroleptic drugs (chlorpromazine, sultopride hydrochloride...)
    - Other drugs: triptans, ergotamine, theophylline, warfarin, thyroxine, floctafenine

    • The patient has previously been administered systemic, intralesional or topical corticosteroids, vincristine, alfa-interferon, imiquimod, propranolol or other beta-blockers.
    • The patient has previously been administered treatment for IH or surgical and/or medical procedures (e.g. laser therapy) have been performed to treat the IH.
    • The patient’s mother has been breastfeeding the patient while she was also being treated with beta-blockers (including propranolol) or, she has been breastfeeding the patient within 14 days of randomisation while she was also being treated with systemic (oral, intra-venous or intra-muscular) corticosteroids, vincristine or alfa-interferon.
    • The patient is known to have a hypersensitivity to propranolol and/or any other beta-blockers and/or any ingredient of the test product.
    • Patient with congenital hemangioma
    • Patient with ulcerated IH.
    • Patient with heart rate < 80 bpm at inclusion
    • Patient with blood pressure < 50/30 mmHg at inclusion
    • Patient with known renal impairment.
    • Patient with known cardiac conditions that may predispose to heart block.
    • The patient has previously experienced an anaphylactic reaction
    • The patient was born prematurely and has not yet reached his/her term equivalent age (e.g. an infant born 2 months prematurely cannot be included before the age of 2 months)
    • Patient with cardiomyopathy.
    • The patient is participating in another clinical study or has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial.
    • The patient has sibling already participating to this clinical study
    • Parent(s) or legal guardian(s) who cannot be contacted by telephone in case of emergency.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy criterion is the evolution of IH from baseline to W12. The binary primary endpoint (success/failure) will be evaluated based on the intra-patient blinded centralised independent qualitative assessments of W12 photographs of the IH compared to baseline. A treatment success will be defined as a centralised assessment of complete/nearly complete resolution of the IH at W12 compared to baseline, where nearly complete resolution is defined as a minimal degree of telangiectasis, erythema, skin thickening, soft tissue swelling and/or distortion of anatomical landmarks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    Secondary efficacy criteria:
    • Centralised assessments of complete/nearly complete resolution of the IH at W4, W8 and W24 compared to baseline,.
    • Investigator on-site qualitative assessments
    - At each scheduled post-baseline visit compared to baseline categorical endpoints for complete/nearly complete resolution
    - At week 4, week 8, week 12 and week 24 compared to baseline categorical endpoints for IH evolution (4-points scale: complete resolution, improvement, stabilisation, worsening)
    - At each scheduled post-baseline visit compared to the previous schedule visit, categorical endpoints for IH evolution (4-points scale: complete resolution, improvement, stabilisation, worsening)
    • Parent(s) or guardian(s) on-site qualitative assessments at each scheduled post-baseline visit compared to the previous scheduled visit
    - Categorical endpoints for IH evolution (4-points scale: complete resolution, improvement, stabilisation, worsening)

    Persistence of efficacy criteria:
    • Persistence of complete/nearly complete resolution of the IH at W24 compared to W12 based on centralised assessments.
    • Investigator qualitative assessments by categorical endpoints for hemangioma evolution (4-points scale: complete resolution, improvement, stabilisation, worsening) at Week 24 (3 months after end of treatment).

    Safety criteria:
    • Safety endpoints will be based on the following evaluations:
    - Adverse events (AE)
    - Height, weight, head circumference, temperature, heart rate, blood pressure, respiratory rate, pulmonary auscultation, liver palpation and global physical examinations (all visits)
    • Local tolerability
    - Very good tolerance : no subjective sign or physical sign of local side effects
    - Good tolerance : transitory subjective signs, without physical sign or necessary modification of the frequency of product application
    - Poor tolerance : persisting subjective signs or physical signs of local side effects, leading to modification of the frequency of the product application but no treatment discontinuation
    - Very poor tolerance: subjective and/or physical signs leading to treatment discontinuation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy criteria: W4, W8, W12 and W24 compared to baseline
    Persistence of efficacy criteria: W24 compared to W12
    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 Yes
    E.6.13.1Other scope of the trial description
    Proof of concept
    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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 80
    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) Yes
    F. of subjects for this age range: 80
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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 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 Yes
    F. of subjects incapable of giving consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    No treatment foreseen after the end of the study.
    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 Decision2012-03-23
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-09
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