{ "FullStudy":{ "Rank":218143, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512173", "OrgStudyIdInfo":{ "OrgStudyId":"V00400 GL 2 01 1A" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-003144-50", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Pierre Fabre Dermatology", "OrgClass":"INDUSTRY" }, "BriefTitle":"Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo", "OfficialTitle":"A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo." }, "StatusModule":{ "StatusVerifiedDate":"October 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 6, 2012", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"October 29, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"October 30, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Pierre Fabre Dermatology", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"There is an unsatisfied medical need for a first-line treatment of localized uncomplicated proliferating Infantile Hemangioma with a good benefit/risk profile.\n\nPierre Fabre Dermatologie has developed a new formulation of propranolol (V0400 GL 01A) which is a topical gel adapted to paediatric use.\n\nThe objective of this study is to evaluate topical propranolol efficacy and safety in the management of localized hemangioma." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Infantile Hemangioma" ] }, "KeywordList":{ "Keyword":[ "Propranolol gel", "Hemangioma", "capillary neoplasm", "vascular tissue", "neoplasm by histologic type", "neoplasm", "therapeutic uses", "pharmacologic actions", "adrenergic beta-antagonists", "adrenergic antagonist", "adrenergics agent", "neurotransmitter agent", "molecular mechanism of pharmacological action", "physiological effects of drugs" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"82", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"propranolol gel", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: propranolol gel" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"propranolol gel", "InterventionDescription":"Topical administration twice daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "propranolol gel" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"Topical administration twice daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Complete/nearly complete resolution of the Infantile Hemangioma at week 12.", "PrimaryOutcomeDescription":"Complete/nearly complete resolution of the Infantile Hemangioma at week 12 compared to baseline", "PrimaryOutcomeTimeFrame":"week 12" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"On-site parent(s) or guardian(s) qualitative assessments of efficacy", "SecondaryOutcomeDescription":"categorical endpoints for Infantile Hemangioma evolution (4-points scale)", "SecondaryOutcomeTimeFrame":"week 2 , week 4, week 8, week 12 and week 24" },{ "SecondaryOutcomeMeasure":"Persistence of efficacy 12 weeks after the end of treatment", "SecondaryOutcomeDescription":"Persistence of complete/nearly complete resolution of the Infantile Hemangioma at week 24 compared to week 12.", "SecondaryOutcomeTimeFrame":"Week 24" },{ "SecondaryOutcomeMeasure":"Safety profile (descriptive analysis of AE)", "SecondaryOutcomeTimeFrame":"Day 0, week 2, week 4, week 8, week 12 and week 24" },{ "SecondaryOutcomeMeasure":"Local tolerance of the propranolol gel(description over time by treatment group)", "SecondaryOutcomeTimeFrame":"week 2, week 4, week 8 and week 12" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Main Inclusion Criteria:\n\nonly one proliferating Infantile Hemangioma present anywhere on the body except on the head, the neck, the hands and on the diaper area, with largest diameter diameter ≥ 1cm and ≤ 5 cm.\n\nMain Exclusion Criteria:\n\nmore than one Infantile Hemangioma with largest diameter ≥ 1cm\nmedically unstable health status that may interfere with his/her ability to complete the study\nInfantile Hemangioma requires, according to Investigator's judgment, a systemic treatment\nthe 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", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"35 Days", "MaximumAge":"150 Days", "StdAgeList":{ "StdAge":[ "Child" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"CHU Bordeaux Hôpital Pellegrin-Enfants - Unité de Dermatologie pédiatrique", "LocationCity":"Bordeaux", "LocationZip":"33076", "LocationCountry":"France" },{ "LocationFacility":"Hôpital Saint Vincent de Paul - Dermatologie Pédiatrique", "LocationCity":"Lille", "LocationZip":"59020", "LocationCountry":"France" },{ "LocationFacility":"CHU Lyon Est Hôpital mère enfant - Consultation des angiomes", "LocationCity":"Lyon Bron", "LocationZip":"69677", "LocationCountry":"France" },{ "LocationFacility":"CHU Timone - Service de dermatologie", "LocationCity":"Marseille", "LocationZip":"13385", "LocationCountry":"France" },{ "LocationFacility":"Hôpital Mère-Enfant - Service de Néonatologie et Réanimation Pédiatrique", "LocationCity":"Nantes", "LocationZip":"44093", "LocationCountry":"France" },{ "LocationFacility":"CHU Necker enfants malades - Service de dermatologie", "LocationCity":"Paris", "LocationZip":"75517", "LocationCountry":"France" },{ "LocationFacility":"CHU Saint-Etienne Hôpital Nord - Service de dermatologie", "LocationCity":"Saint-Etienne", "LocationZip":"42055", "LocationCountry":"France" },{ "LocationFacility":"CHU Toulouse Hôpital des enfants - Département cardio-pédiatrique", "LocationCity":"Toulouse", "LocationZip":"31100", "LocationCountry":"France" },{ "LocationFacility":"Hôpital de Clocheville - Centre de Pédiatrie Gatien", "LocationCity":"Tours", "LocationZip":"37044", "LocationCountry":"France" },{ "LocationFacility":"Pomorskie Centrum Traumatologii im. M. Kopernika w Gdańsku Klinika Chirurgii i Urologii Dzieci i Młodzieży GUMed", "LocationCity":"Gdańsk", "LocationZip":"80-803", "LocationCountry":"Poland" },{ "LocationFacility":"Uniwersytet Medyczny w Łodzi Klinika Chirurgii i Onkologii Dziecięcej", "LocationCity":"Lodz", "LocationZip":"91-738", "LocationCountry":"Poland" },{ "LocationFacility":"Instytut \"Pomnik-Centrum Zdrowia Dziecka\", Klinika Onkologii", "LocationCity":"Warszawa", "LocationZip":"04-730", "LocationCountry":"Poland" },{ "LocationFacility":"Hospital Sant Pau de Barcelona", "LocationCity":"Barcelona", "LocationZip":"08025", "LocationCountry":"Spain" },{ "LocationFacility":"Hospital Universitario Infantil Niño Jesús", "LocationCity":"Madrid", "LocationZip":"28009", "LocationCountry":"Spain" },{ "LocationFacility":"Hospital La Paz", "LocationCity":"Madrid", "LocationZip":"28056", "LocationCountry":"Spain" },{ "LocationFacility":"Hospital Universitario Virgen del Rocio", "LocationCity":"Sevilla", "LocationZip":"41013", "LocationCountry":"Spain" },{ "LocationFacility":"Hospital General Universitario de Valencia", "LocationCity":"Valencia", "LocationZip":"46014", "LocationCountry":"Spain" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000011433", "InterventionMeshTerm":"Propranolol" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000319", "InterventionAncestorTerm":"Adrenergic beta-Antagonists" },{ "InterventionAncestorId":"D000018674", "InterventionAncestorTerm":"Adrenergic Antagonists" },{ "InterventionAncestorId":"D000018663", "InterventionAncestorTerm":"Adrenergic Agents" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000889", "InterventionAncestorTerm":"Anti-Arrhythmia Agents" },{ "InterventionAncestorId":"D000000959", "InterventionAncestorTerm":"Antihypertensive Agents" },{ "InterventionAncestorId":"D000014665", "InterventionAncestorTerm":"Vasodilator Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M12881", "InterventionBrowseLeafName":"Propranolol", "InterventionBrowseLeafAsFound":"Propranolol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2252", "InterventionBrowseLeafName":"Adrenergic beta-Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19330", "InterventionBrowseLeafName":"Adrenergic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19339", "InterventionBrowseLeafName":"Adrenergic Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2794", "InterventionBrowseLeafName":"Anti-Arrhythmia Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2858", "InterventionBrowseLeafName":"Antihypertensive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15995", "InterventionBrowseLeafName":"Vasodilator Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"AnArAg", "InterventionBrowseBranchName":"Anti-Arrhythmia Agents" },{ "InterventionBrowseBranchAbbrev":"AnAg", "InterventionBrowseBranchName":"Antihypertensive Agents" },{ "InterventionBrowseBranchAbbrev":"VaDiAg", "InterventionBrowseBranchName":"Vasodilator Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000006391", "ConditionMeshTerm":"Hemangioma" },{ "ConditionMeshId":"D000018324", "ConditionMeshTerm":"Hemangioma, Capillary" },{ "ConditionMeshId":"D000019339", "ConditionMeshTerm":"Port-Wine Stain" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009383", "ConditionAncestorTerm":"Neoplasms, Vascular Tissue" },{ "ConditionAncestorId":"D000009370", "ConditionAncestorTerm":"Neoplasms by Histologic Type" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000012868", "ConditionAncestorTerm":"Skin Abnormalities" },{ "ConditionAncestorId":"D000000013", "ConditionAncestorTerm":"Congenital Abnormalities" },{ "ConditionAncestorId":"D000012871", "ConditionAncestorTerm":"Skin Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M19052", "ConditionBrowseLeafName":"Hemangioma, Capillary", "ConditionBrowseLeafAsFound":"Infantile Hemangioma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8062", "ConditionBrowseLeafName":"Hemangioma", "ConditionBrowseLeafAsFound":"Hemangioma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M19900", "ConditionBrowseLeafName":"Port-Wine Stain", "ConditionBrowseLeafAsFound":"Infantile Hemangioma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10898", "ConditionBrowseLeafName":"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12", "ConditionBrowseLeafName":"Congenital Abnormalities", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14255", "ConditionBrowseLeafName":"Skin Abnormalities", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14257", "ConditionBrowseLeafName":"Skin Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC16", "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" } ] } } } } } }