{ "FullStudy":{ "Rank":218159, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511965", "OrgStudyIdInfo":{ "OrgStudyId":"06-API-01" }, "Organization":{ "OrgFullName":"Centre Hospitalier Universitaire de Nice", "OrgClass":"OTHER" }, "BriefTitle":"Study of Applications of Autologous Epidermal Cells in Liquid Phase in the Treatment of Vitiligo", "Acronym":"Viticell" }, "StatusModule":{ "StatusVerifiedDate":"January 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"November 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 2, 2012", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 31, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 3, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Centre Hospitalier Universitaire de Nice", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Vitiligo is a depigmenting skin disease common. Vitiligo is caused by the disappearance of melanocytes in the epidermis. Vitiligo is the cause of disfigurement, psychological and social, that sounds a lot about the quality of life. Currently the standard treatment for vitiligo is ultraviolet ray (UV), but it only allows a 50% repigmentation of lesions in half of patients. The applications of autologous epidermal cells in the liquid phase is a promising new therapeutic approach of vitiligo.\n\nThe main goal of this study is to compare prospectively the repigmentation of vitiligo lesions induced by application of autologous epidermal cells in liquid phase associated with light therapy and light therapy alone.\n\nStudy's secondary goals: compare the applications of epidermal cells to phototherapy alone and phototherapy, in respect of:\n\nObtain a repigmentation> 70% (threshold considered aesthetically relevant)\nThe occurrence of adverse events\nPatient satisfaction regarding the efficacy and safety of treatment", "DetailedDescription":"MAIN CRITERIA\n\nRates of repigmentation of the vitiligo lesions to 12 months\nThe lesions of the layers defined by the investigator to Month 0, Month 3, Month 6 and Month 12 will be analyzed by an image analysis system managed by a computer.\nDigital photos is taken in order to illustrate the quantitative results above.\n\nSECONDARY CRITERIA\n\nRepigmentation> 70% of the vitiligo lesions at 12 months\nRates of repigmentation of the vitiligo lesions at 12 months\nSide effects: the frequency, severity and time of occurrence will be reported for each treatment. Side effects are classified into grades according to World Health Organization (WHO) criteria.\nPatient satisfaction of the effectiveness and tolerance will be studied using visual analogue scales graded from 0 to 10." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Vitiligo" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1", "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"23", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"traitement A", "ArmGroupType":"Other", "ArmGroupDescription":"Lesion 1= graft and lesion 2 = UltraViolet B", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: autologous (cellular therapy)" ] } },{ "ArmGroupLabel":"traitement B", "ArmGroupType":"Other", "ArmGroupDescription":"Lesion 1 = UltraViolet B and lesion 2 = graft", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: autologous (cellular therapy)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"autologous (cellular therapy)", "InterventionDescription":"The skin sample, the preparation and implementation of the epidermal cells, are conducted on one day. A review of selected lesions is performed and a photograph. Second, are performed successively in a single day the collection of thin skin, preparing the cell suspension, a desepidermisation laser Erbium: YAG lesions of vitiligo to be grafted, and applicated.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "traitement A", "traitement B" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Rate of repigmentation of vitiligo lesion to 12 months", "PrimaryOutcomeDescription":"The lesions defined by the investigator to Month 0, Month 3, Month 6 and Month 12 will be analyzed by an image analysis system managed by a PC computer. Digital photos will be taken in order to illustrate the quantitative results above.", "PrimaryOutcomeTimeFrame":"12 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Repigmentation> 70% of vitiligo lesion at 6 months", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"Side effects", "SecondaryOutcomeDescription":"the frequency, severity and time of occurrence of side effects will be reported for each treatment. Side effects are classified into grades according to WHO criteria.", "SecondaryOutcomeTimeFrame":"12 months" },{ "SecondaryOutcomeMeasure":"Patient satisfaction", "SecondaryOutcomeDescription":"Patient satisfaction and tolerance will be studied using visual analogue scales graded from 0 to 10.", "SecondaryOutcomeTimeFrame":"12 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nElderly patients at least 18 years\nSubjects with a stable vitiligo (no new injury or lack of expansion of existing lesions in the last 12 months), with at least two vitiligo lesions of at least 10 cm2 located in the same anatomical location, and requiring treatment with UVB phototherapy.\nTopic with vitiligo\nSubjects who agreed to have a blood research with Human immunodeficiency virus (HIV), Human T-lymphotropic virus - 1 (HTLV-1), hepatitis B, hepatitis C, and human Chorionic Gonadotropinfor (hCG) women.\nFor women of childbearing age, the use of effective contraception (birth control pills or Intrauterine Device (IUD)) for the duration of the study\nTopics able to participate and to respect it.\nTopics affiliated to social security.\nTopics that have signed a written informed consent before the start of the study.\n\nExclusion Criteria:\n\nPregnant or nursing women.\nSubjects with a history of keloid scarring.\nSubjects with a history of melanoma.\nSubjects with a photodermatitis.\nTopics taking photosensitizing treatment.\nSubjects who received treatment for vitiligo in the 4 weeks before enrollment.\nSubjects with HIV testing, hepatitis B or hepatitis C positive.\nMajor Topics protected by law", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Philippe Bahadoran, PH", "OverallOfficialAffiliation":"Centre Hospitalier Universitaire de Nice", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"service de Dermatologie - Hôpital l'Archet", "LocationCity":"Nice", "LocationZip":"06200", "LocationCountry":"France" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000014820", "ConditionMeshTerm":"Vitiligo" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000017496", "ConditionAncestorTerm":"Hypopigmentation" },{ "ConditionAncestorId":"D000010859", "ConditionAncestorTerm":"Pigmentation Disorders" },{ "ConditionAncestorId":"D000012871", "ConditionAncestorTerm":"Skin Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M16146", "ConditionBrowseLeafName":"Vitiligo", "ConditionBrowseLeafAsFound":"Vitiligo", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M18344", "ConditionBrowseLeafName":"Hypopigmentation", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12337", "ConditionBrowseLeafName":"Pigmentation Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14257", "ConditionBrowseLeafName":"Skin Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }