{ "FullStudy":{ "Rank":217629, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518907", "OrgStudyIdInfo":{ "OrgStudyId":"AUX-CC-830" }, "Organization":{ "OrgFullName":"Endo Pharmaceuticals", "OrgClass":"INDUSTRY" }, "BriefTitle":"The Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)", "OfficialTitle":"A Phase 1b, Open-label, Dose-escalation Study of the Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy Commonly Known as Cellulite" }, "StatusModule":{ "StatusVerifiedDate":"March 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 24, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 17, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 19, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Endo Pharmaceuticals", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This study will evaluate the safety, effectiveness, pharmacokinetics, and immunogenicity of AA4500 at increasing doses and concentrations in the treatment of adult women with cellulite." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Edematous Fibrosclerotic Panniculopathy", "Cellulite" ] }, "KeywordList":{ "Keyword":[ "cellulite", "Xiaflex" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"99", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"AA4500 0.0029 mg in 1 mL", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM" ] } },{ "ArmGroupLabel":"AA4500 0.0145 mg in 5 mL", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM" ] } },{ "ArmGroupLabel":"AA4500 0.0145 mg in 1 mL", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM" ] } },{ "ArmGroupLabel":"AA4500 0.0435 mg in 5 mL", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM" ] } },{ "ArmGroupLabel":"AA4500 0.0435 mg in 1 mL", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM" ] } },{ "ArmGroupLabel":"AA4500 0.116 mg in 5 mL", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM" ] } },{ "ArmGroupLabel":"AA4500 0.116 mg in 1 mL", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM" ] } },{ "ArmGroupLabel":"AA4500 0.232 mg in 5 mL", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM" ] } },{ "ArmGroupLabel":"AA4500 at 0.232 in 1 mL", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM" ] } },{ "ArmGroupLabel":"AA4500 0.464 mg in 5 mL", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM" ] } },{ "ArmGroupLabel":"AA4500 0.464 mg in 1 mL", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Biological", "InterventionName":"COLLAGENASE CLOSTRIDIUM HISTOLYTICUM", "InterventionDescription":"Subdermal dose", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "AA4500 0.0029 mg in 1 mL", "AA4500 0.0145 mg in 1 mL", "AA4500 0.0145 mg in 5 mL", "AA4500 0.0435 mg in 1 mL", "AA4500 0.0435 mg in 5 mL", "AA4500 0.116 mg in 1 mL", "AA4500 0.116 mg in 5 mL", "AA4500 0.232 mg in 5 mL", "AA4500 0.464 mg in 1 mL", "AA4500 0.464 mg in 5 mL", "AA4500 at 0.232 in 1 mL" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "XIAFLEX", "XIAPEX" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Investigator global aesthetic improvement scale assessment of the target cellulite area", "PrimaryOutcomeTimeFrame":"Day 90" },{ "PrimaryOutcomeMeasure":"Subject global aesthetic improvement scale assessment of the target cellulite area", "PrimaryOutcomeTimeFrame":"Day 90" },{ "PrimaryOutcomeMeasure":"A responder analysis based on proportion of subjects with a ≥ 30% improvement from baseline in the absolute surface depth of the central dimple/depression based on 3D digital photography.", "PrimaryOutcomeTimeFrame":"Day 90" },{ "PrimaryOutcomeMeasure":"Percent change from baseline in total absolute surface depth of the central dimple/depression based on 3D digital photography.", "PrimaryOutcomeTimeFrame":"Day 90" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nBe a female and be ≥ 21 years of age and ≤ 60 years of age\nHave a skin type classification of I through V according to the Fitzpatrick scale\nHave EFP within the posterolateral thigh(s) and/or buttock(s) for at least 12 months before the screening visit\nHave a photonumeric cellulite severity scale (CSS) score of ≥ 7 representing moderate to severe cellulite severity within the right or left buttock or the right or left posterolateral thigh (selected quadrant)\n\nHave an area of EFP within the selected quadrant that is at least 8 cm x 10 cm (ie, target EFP area) and is suitable for treatment:\n\nThe target EFP area must be located on the posterolateral thigh or within the buttock and does not involve the gluteal fold\nThe target EFP area must be evident when the subject is standing, without the use of any manipulation such as skin pinching or muscle contraction (ie, CSS Classification E score of 2 or 3) at screening and before injection\nHave a Body Mass Index (BMI) between 20.0 and 33.0 kg/m2, and intends to maintain stable body weight throughout the duration of the study (a variation of ≤5% from baseline body weight is permitted)\nBe willing to refrain from using artificial tanning devices and lotions during the 2-week period before screening and throughout the duration of the study\nBe willing to apply sunscreen with sun protection factor (SPF) ≥15 to the selected quadrant before each exposure to the sun while participating in the study (ie, screening through Day 90)\nBe judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening\nHave a negative urine pregnancy test at screening and before injection of AA4500 and be using an effective contraception method (ie, abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for the duration of the study, or be surgically sterile, or be a postmenopausal female (no menses for at least 1 year or hysterectomy)\nBe willing and able to cooperate with the requirements of the study including requirements during the confinement period and throughout the study\nVoluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC). The subject must also sign an authorization form to allow disclosure of her protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution\nBe able to complete and understand the various rating instruments in English\n\nExclusion Criteria:\n\nHas any of the following conditions:\n\nThyroid disease, unless controlled with medication for ≥ 6 months\nUncontrolled diabetes mellitus, as determined by the investigator\nUncontrolled hypertension, as determined by the investigator\nVascular disorder (eg, phlebitis or varicose veins) in area to be treated\nLipedema or a lymphatic disorder\nHistory of lower extremity thrombosis or post-thrombosis syndrome\nDocumented autoimmune disorder such as lupus erythematosus, rheumatoid arthritis\nInflammation or active infection in area to be treated\nCutaneous alteration in area to be treated\nRash, eczema, psoriasis, or skin cancer in the area to be treated\nHistory of keloidal scarring or abnormal wound healing\nCoagulation disorder; taking an anticoagulant (except for ≤ 150 mg aspirin daily) up to 7 days prior to injection day\nKnown active hepatitis B or C (history of hepatitis A is permitted)\nKnown immune deficiency disease or a positive test for human immunodeficiency virus (HIV)\nOther significant conditions including body dysmorphic disorder, which in the investigator's opinion would make the subject unsuitable for enrollment in the study\n\nHas used any of the following for the treatment of EFP on the legs or buttock or intends to use any of the following at any time during the study:\n\nLiposuction at any time before injection of AA4500\nInjections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision) within 12 months before injection of AA4500\nEndermologie or similar treatments within 6 months before injection of AA4500\nMassage therapy within 3 months before injection of AA4500\nCreams to prevent or mitigate EFP within 2 weeks before injection of AA4500\nHas a tattoo in the quadrant selected for treatment\nIs presently nursing a baby or providing breast milk for a baby\nIntends to become pregnant during the study\nIntends to initiate an intensive sport or exercise program during the study\nHas an unrealistic expectation for treatment outcome, as determined by the investigator\nHas a positive alcohol breath test and/or a positive urine drug screen for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and/or propoxyphene at screening or Day -1\nHas received an investigational drug or treatment within 30 days before injection of AA4500\nHas a known systemic allergy to collagenase or any other excipient of AA4500\nHas received any collagenase treatments within 30 days before treatment\nHas, at any time, received AA4500", "HealthyVolunteers":"No", "Gender":"Female", "MinimumAge":"21 Years", "MaximumAge":"60 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Veronica Urdaneta, MD MPH", "OverallOfficialAffiliation":"Endo Pharmaceuticals", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"SNBL Clinical Pharmacology Center, Inc", "LocationCity":"Baltimore", "LocationState":"Maryland", "LocationZip":"21201", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000071697", "ConditionMeshTerm":"Cellulite" },{ "ConditionMeshId":"D000004487", "ConditionMeshTerm":"Edema" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012877", "ConditionAncestorTerm":"Skin Manifestations" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M6240", "ConditionBrowseLeafName":"Edema", "ConditionBrowseLeafAsFound":"Edematous", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M848", "ConditionBrowseLeafName":"Cellulite", "ConditionBrowseLeafAsFound":"Cellulite", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14263", "ConditionBrowseLeafName":"Skin Manifestations", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }