{ "FullStudy":{ "Rank":217677, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518270", "OrgStudyIdInfo":{ "OrgStudyId":"GMA-LTS-11-003" }, "Organization":{ "OrgFullName":"Allergan", "OrgClass":"INDUSTRY" }, "BriefTitle":"Epidemiologic Analysis of Change in Eyelash Characteristics With Age in Healthy Women" }, "StatusModule":{ "StatusVerifiedDate":"April 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 1, 2011", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 16, 2011", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 16, 2011", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"November 9, 2012", "ResultsFirstSubmitQCDate":"November 9, 2012", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"December 5, 2012", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"April 18, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 1, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Allergan", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This study will asses epidemiologic changes in eyelash characteristics with increasing age." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Health" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Ecologic or Community" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"179", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Healthy Females", "ArmGroupDescription":"Healthy Females", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: No treatment" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"No treatment", "InterventionDescription":"No treatment will be provided", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Healthy Females" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Eyelash Length as Measured by Digital Image Analysis (DIA)", "PrimaryOutcomeDescription":"Photographs were taken of the eyelashes. Length was measured in millimeters. Data from both eyes were averaged for each participant for analysis.", "PrimaryOutcomeTimeFrame":"Baseline" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Eyelash Thickness as Measured by Digital Image Analysis (DIA)", "SecondaryOutcomeDescription":"Photographs were taken of the eyelashes. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2).", "SecondaryOutcomeTimeFrame":"Baseline" },{ "SecondaryOutcomeMeasure":"Eyelash Darkness as Measured by Digital Image Analysis (DIA)", "SecondaryOutcomeDescription":"Photographs were taken of the Eyelashes. Eyelash darkness (intensity) was measured within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white.", "SecondaryOutcomeTimeFrame":"Baseline" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nWilling to have photographs taken of the face/eye regions\n\nExclusion Criteria:\n\nNo visible eyelashes\nPermanent eyeliner or eyelash implants\nSemi-permanent eyelash tint, dye, or extensions within the last 3 months\nUse of prescription eyelash growth products in the last 6 months", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"Female", "MinimumAge":"18 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"Healthy Females", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Medical Director", "OverallOfficialAffiliation":"Allergan", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Irvine", "LocationState":"California", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"25347452", "ReferenceType":"background", "ReferenceCitation":"Glaser DA, Jones D, Carruthers J, Campo A, Moench S, Tardie G, Largent J, Caulkins C. Epidemiologic analysis of change in eyelash characteristics with increasing age in a population of healthy women. Dermatol Surg. 2014 Nov;40(11):1208-13. doi: 10.1097/DSS.0000000000000170." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Healthy Females", "FlowGroupDescription":"Participant's eyelashes were photographed at one study visit." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"179" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"179" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Healthy Females", "BaselineGroupDescription":"Participant's eyelashes were photographed at one study visit." } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"179" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"Years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"40.3", "BaselineMeasurementSpread":"10.3", "BaselineMeasurementLowerLimit":"22.0", "BaselineMeasurementUpperLimit":"65.0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"179" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Eyelash Length as Measured by Digital Image Analysis (DIA)", "OutcomeMeasureDescription":"Photographs were taken of the eyelashes. Length was measured in millimeters. Data from both eyes were averaged for each participant for analysis.", "OutcomeMeasurePopulationDescription":"All participants with values available.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"Millimeters (mm)", "OutcomeMeasureTimeFrame":"Baseline", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Healthy Females", "OutcomeGroupDescription":"Participant's eyelashes were photographed at one study visit." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"177" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.33", "OutcomeMeasurementSpread":"1.15", "OutcomeMeasurementLowerLimit":"3.99", "OutcomeMeasurementUpperLimit":"10.10" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Eyelash Thickness as Measured by Digital Image Analysis (DIA)", "OutcomeMeasureDescription":"Photographs were taken of the eyelashes. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2).", "OutcomeMeasurePopulationDescription":"All participants with values available.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"Millimeters squared (mm^2)", "OutcomeMeasureTimeFrame":"Baseline", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Healthy Females", "OutcomeGroupDescription":"Participant's eyelashes were photographed at one study visit." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"153" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.39", "OutcomeMeasurementSpread":"0.56", "OutcomeMeasurementLowerLimit":"0.32", "OutcomeMeasurementUpperLimit":"3.13" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Eyelash Darkness as Measured by Digital Image Analysis (DIA)", "OutcomeMeasureDescription":"Photographs were taken of the Eyelashes. Eyelash darkness (intensity) was measured within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white.", "OutcomeMeasurePopulationDescription":"All participants with values available.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"Units on a scale", "OutcomeMeasureTimeFrame":"Baseline", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Healthy Females", "OutcomeGroupDescription":"Participant's eyelashes were photographed at one study visit." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"154" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"122.2", "OutcomeMeasurementSpread":"14.0", "OutcomeMeasurementLowerLimit":"64.7", "OutcomeMeasurementUpperLimit":"162.5" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsDescription":"Adverse events were not collected.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Healthy Females", "EventGroupDescription":"Healthy Females", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"0", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"0" } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"OTHER", "AgreementRestrictiveAgreement":"Yes", "AgreementOtherDetails":"A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo." }, "PointOfContact":{ "PointOfContactTitle":"Vice President Medical Affairs,", "PointOfContactOrganization":"Allergan, Inc", "PointOfContactEMail":"clinicaltrials@allergan.com", "PointOfContactPhone":"714-246-4500" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" } } } } }