{
  "FullStudy":{
    "Rank":217671,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518348",
          "OrgStudyIdInfo":{
            "OrgStudyId":"Mekos 107P3.2 401"
          },
          "Organization":{
            "OrgFullName":"Allerderm",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents",
          "OfficialTitle":"Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents",
          "Acronym":"PREAII"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2013",
          "OverallStatus":"Withdrawn",
          "WhyStopped":"Study has been updated with new protocol number",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2013",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2013",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"March 16, 2011",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 26, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 27, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Allerderm",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"To evaluate the diagnostic performance (primary) and safety (secondary) of seven T.R.U.E. Test Panel 3.2 allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol in pediatric subjects 6-18 years of age with suspected contact dermatitis based on symptoms and clinical history.",
          "DetailedDescription":"The study population will include at least 100 consecutive subjects 6-17 years of age with suspected contact dermatitis based on symptoms and clinical history. Study subjects must be otherwise healthy and fulfill entry criteria.\n\nVisit 1 (Day 0): Informed Consent, Inclusion/Exclusion Criteria Assessment, Medical and Medicine History, Pregnancy Test (for female subjects of child-bearing potential), Panel Placement.Visit 2 (Day 2): Panel Removal, Panel Adhesion and Irritation Assessment, AE and Concomitant Medication Review.Visit 3 (Day 3- approximately 72 hours after placement): Skin Reactions Assessed and Scored. Adverse Event and Concomitant Medication Review.Visit 4 (Day 4 approximately 96 hours after placement): Skin Reactions Assessed and Scored. Adverse Event and Concomitant Medication Review.Visit 5 (Day 7±1): Skin Reaction Assessed and Scored. AE and Concomitant Medication Review. Visit 6 (Day 21±2): Skin Reaction Assessed and Scored. AE and Concomitant Medication Review. Visit performed via phone call, unless investigator determines that subject should be seen in clinic.\n\nPrimary Endpoint: Frequency and characterization of positive reactions per allergen. Secondary Endpoint: Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Contact Dermatitis"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Patch Test",
              "Contact Dermatitis",
              "Allergy",
              "Children",
              "PREA"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Diagnostic",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"0",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Patch Test",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Biological: Patch Test"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Biological",
                "InterventionName":"Patch Test",
                "InterventionDescription":"Patch Tested with Gold sodium thiosulfate, 0.075 mg/cm2 in hydroxypropylcellulose · Hydrocortisone-17-butyrate, 0.020 mg/cm2 in polyvinylpyrrolidone· Methyldibromoglutaronitrile, 0.0053 mg/cm2 in polyvinylpyrrolidone·Bacitracin, 0.60 mg/cm2 in hydroxypropylcellulose· Parthenolide, 0.0030 mg/cm2 in polyvinylpyrrolidone· Disperse blue 106, 0.050 mg/cm2 in polyvinylpyrrolidone· Bronopol, 0.25 mg/cm2 in polyvinylpyrrolidone",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Patch Test"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "T.R.U.E. TEST"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change in Frequency and characterization of positive reactions per allergen.",
                "PrimaryOutcomeTimeFrame":"72 hours, 96 hours, 1 week, 21 Days"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events.",
                "SecondaryOutcomeTimeFrame":"72 hours, 96 hours, 1 week, 21 days"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nSymptoms and history potentially consistent with allergic contact dermatitis based on symptoms and clinical history (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition).\nChildren and adolescents 6 to 18 years of age, and in general good health.\nAdolescent females 15 years of age or older (or with menarche) must consent to a urine pregnancy test; urine test results must be negative for study inclusion.\nInformed consent must be signed and understood by subject. If under age, informed consent must be signed and understood by parent or legal guardian, consistent with all institutional, local and national regulations.\n\nExclusion Criteria:\n\nTopical corticosteroid treatment during the last 7 days on or near the test area.\nSystemic treatment with corticosteroids or other immunosuppressives during the last 7 days.\nSubjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study.\nTreatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks.\nAcute dermatitis outbreak or dermatitis on or near the test area on the back.\nSubjects unable to comply with activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).\nSubjects unable or unwilling to comply with multiple return visits.\nFemale subjects 15 years of age (or with onset of menarche) and older unable to consent to a urine pregnancy test, or those with a positive pregnancy test.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"6 Years",
          "MaximumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Cory Dunnick, MD",
                "OverallOfficialAffiliation":"Anschutz Health and Wellness Center, University of Colorado, Aurora, Colorado",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Joseph Fowler, MD",
                "OverallOfficialAffiliation":"Dermatology Specialists, Louisville, KY",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Anschutz Health and Wellness Center, University of Colorado",
                "LocationCity":"Aurora",
                "LocationState":"Colorado",
                "LocationZip":"80045",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Dermatology Specialists",
                "LocationCity":"Louisville",
                "LocationState":"Kentucky",
                "LocationZip":"40202",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000003872",
                "ConditionMeshTerm":"Dermatitis"
              },{
                "ConditionMeshId":"D000003877",
                "ConditionMeshTerm":"Dermatitis, Contact"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012871",
                "ConditionAncestorTerm":"Skin Diseases"
              },{
                "ConditionAncestorId":"D000017443",
                "ConditionAncestorTerm":"Skin Diseases, Eczematous"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8601",
                "ConditionBrowseLeafName":"Hypersensitivity",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5650",
                "ConditionBrowseLeafName":"Dermatitis",
                "ConditionBrowseLeafAsFound":"Dermatitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5655",
                "ConditionBrowseLeafName":"Dermatitis, Contact",
                "ConditionBrowseLeafAsFound":"Contact Dermatitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14257",
                "ConditionBrowseLeafName":"Skin Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M18295",
                "ConditionBrowseLeafName":"Skin Diseases, Eczematous",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC20",
                "ConditionBrowseBranchName":"Immune System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC17",
                "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases"
              }
            ]
          }
        }
      }
    }
  }
}