{
  "FullStudy":{
    "Rank":217791,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516788",
          "OrgStudyIdInfo":{
            "OrgStudyId":"814860"
          },
          "Organization":{
            "OrgFullName":"University of Pennsylvania",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Photoprovocation Testing in Subjects With Cutaneous Lupus",
          "OfficialTitle":"Photoprovocation Testing in Subjects With Cutaneous Lupus"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2019",
          "OverallStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2020",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2020",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 12, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 10, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 11, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Pennsylvania",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Photosensitivity is well documented among lupus patients and is one of the diagnostic criteria for systemic lupus erythematosus (SLE). Photosensitivity is highly prevalent in lupus and has a wide range of clinical presentations. However, photosensitivity is a poorly defined in lupus and its pathogenesis is not well understood. The purpose of this study is to characterize the early clinical and histopathological changes in lupus skin that occur as a response to ultraviolet light."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Lupus Erythematosus",
              "Photosensitivity Conditions"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Basic Science",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"50",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Phototesting",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Phototesting"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Phototesting",
                "InterventionDescription":"Single MED dose on Day 2",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Phototesting"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours.",
                "PrimaryOutcomeTimeFrame":"24 hours and 48 hours"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nParticipants who have a diagnosis of CLE based on either the Gilliam classification of DLE and SCLE, or SLE based on the American College of Rheumatology criteria.\n\nExclusion Criteria:\n\nParticipants who do not meet criteria for either CLE or SLE.\nParticipants with a diagnosis of Erythropoietic Protoporphyria and Solar Urticaria, or another photodermatoses other than Polymorphous light eruption.\nParticipants who are not yet 18 years old or who are not capable of giving written informed consent prior to enrolling in the study.\nParticipants who have undergone any recent phototesting, or phototherapy exposure, or those who are suspected of having a drug-induced photosensitivity.\nFemale participants who are pregnant or breastfeeding will be excluded from the study. This will be determined by patient self-reporting.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University of Pennsylvania",
                "LocationStatus":"Recruiting",
                "LocationCity":"Philadelphia",
                "LocationState":"Pennsylvania",
                "LocationZip":"19104",
                "LocationCountry":"United States",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Victoria Werth, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"215-898-0168",
                      "LocationContactEMail":"werth@mail.med.upenn.edu"
                    },{
                      "LocationContactName":"Victoria Werth, MD",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}