{ "FullStudy":{ "Rank":217812, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516515", "OrgStudyIdInfo":{ "OrgStudyId":"GESRTAKB" }, "Organization":{ "OrgFullName":"G&E Herbal Biotechnology Co., LTD", "OrgClass":"INDUSTRY" }, "BriefTitle":"Efficacy and Safety Phase II Study of SR-T100 to Treat Actinic Keratosis", "OfficialTitle":"A Double-blind, Randomized, Vehicle-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of SR-T100 Gel in Patients With Actinic Keratosis (AK)" }, "StatusModule":{ "StatusVerifiedDate":"December 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2013" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2017", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 2018", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 17, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"December 3, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 5, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"G&E Herbal Biotechnology Co., LTD", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This Phase II study is to evaluate the efficacy of SR-T100 gel with 2.3% of SM in Solanum undatum plant extract in patient with Actinic Keratosis (AK)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Actinic Keratosis" ] }, "KeywordList":{ "Keyword":[ "Actinic Keratosis", "AK" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"86", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"placebo, gel", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"placebo comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Vehicle gel" ] } },{ "ArmGroupLabel":"SR-T100 with 2.3% of SM, gel", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"2.3% of SM in Solanum undatum plant extract", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: SR-T100 with 2.3% of SM" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Vehicle gel", "InterventionDescription":"placebo", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "placebo, gel" ] } },{ "InterventionType":"Drug", "InterventionName":"SR-T100 with 2.3% of SM", "InterventionDescription":"2.3% of SM in Solanum undatum plant extract", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "SR-T100 with 2.3% of SM, gel" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "SR-T100" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Total clearance rate:", "PrimaryOutcomeDescription":"The proportion of patients achieving total clearance of AK lesions in the treatment area (in total of 25cm2 area) at 8-week post-EOT visit (scheduled at Week 24 visit) .", "PrimaryOutcomeTimeFrame":"8-week post-EOT visit (scheduled at Week 24 visit)" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Partial clearance rate", "SecondaryOutcomeDescription":"The proportion of patients achieving ≥ 75% total clinically assessed AK lesion counts out of all target lesions in the treatment area (in total of 25cm2 area) at the post-EOT visit (8 weeks after EOT visit).", "SecondaryOutcomeTimeFrame":"24 week" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMale or female; aged ≥ 18 years old.\nPatient who accepts to enter the study by signing written informed consent.\nPatient has 4 to 8 clinically diagnosed, discrete, non-hyperkeratotic, non-hypertrophic AK, located with or without a contiguous 25cm2 areas.\nPatient allows biopsy to be performed on selected lesion.\nPatient agrees to apply the study medication on prescribed treatment area with an occlusive dressing at least 20 hours per day.\nPatient agrees photographs to be taken on selected lesion and used as part of the study data package.\nPatient in good general health condition (performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG).\nSexually active female patient with child-bearing potential must take reliable contraception method(s) during the participation of the study.\n\nExclusion Criteria:\n\nPatient with recurrent invasive squamous cell carcinoma (SCC).\nPatient has grossly suspicious or inflamed lymph nodes on physical examination.\nPatient has evidence of clinically significant or unstable medical conditions.\nPatient has any skin condition in the treatment area that may be made worse by treatment.\nPatient currently uses or had used on the treatment area(s) OTC retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil (5-FU), imiquimod, topical diclofenac, retinoids, or other topical AK treatments (such as laser abrasion, dermabrasion, glycolic acids, or chemical peels) 28 days prior to screening visit.\nPatient had received systemic cancer chemotherapy or immunosuppressant; on the target evaluation area that psoralen plus UVA therapy, UVB therapy were treated 6 months prior to screening visit.\nPatient currently uses or has used prednisone and/or prednisolone (≥ 10 mg or the equivalent) more than 2 weeks continuously within 12 weeks prior to randomization visit.\nEngaging in activities involving excessive or prolonged exposure to sunlight.\nHistory of allergy or sensitivity to related compounds or other components of the investigational product formulation.\nWoman who is pregnant, lactating or planning to become pregnant during the study.\nPatient used any investigational drug within 8 weeks prior to the screening visit.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"Contour Dermatology & Cosmetic Surgery Center", "LocationCity":"Rancho Mirage", "LocationState":"California", "LocationZip":"92270", "LocationCountry":"United States" },{ "LocationFacility":"IMMUNOe International Research Centers", "LocationCity":"Longmont", "LocationState":"Colorado", "LocationZip":"80501", "LocationCountry":"United States" },{ "LocationFacility":"Atlantic Clinical Research Collaborative", "LocationCity":"West Palm Beach", "LocationState":"Florida", "LocationZip":"33406", "LocationCountry":"United States" },{ "LocationFacility":"Palm Beach Research Center", "LocationCity":"West Palm Beach", "LocationState":"Florida", "LocationZip":"33409", "LocationCountry":"United States" },{ "LocationFacility":"Suzanne Bruce and Associates,P.A. The Center for Skin Research", "LocationCity":"Katy", "LocationState":"Texas", "LocationZip":"77056", "LocationCountry":"United States" },{ "LocationFacility":"Pflugerville Dermatology Clinical Research", "LocationCity":"Pflugerville", "LocationState":"Texas", "LocationZip":"78660", "LocationCountry":"United States" },{ "LocationFacility":"The Education & Research Foundation, Inc", "LocationCity":"Lynchburg", "LocationState":"Virginia", "LocationZip":"24501", "LocationCountry":"United States" },{ "LocationFacility":"Premier Clinical Research", "LocationCity":"Spokane", "LocationState":"Washington", "LocationZip":"99204", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000055623", "ConditionMeshTerm":"Keratosis, Actinic" },{ "ConditionMeshId":"D000007642", "ConditionMeshTerm":"Keratosis" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012871", "ConditionAncestorTerm":"Skin Diseases" },{ "ConditionAncestorId":"D000011230", "ConditionAncestorTerm":"Precancerous Conditions" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M9251", "ConditionBrowseLeafName":"Keratosis", "ConditionBrowseLeafAsFound":"Keratosis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M26855", "ConditionBrowseLeafName":"Keratosis, Actinic", "ConditionBrowseLeafAsFound":"Actinic Keratosis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14257", "ConditionBrowseLeafName":"Skin Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12694", "ConditionBrowseLeafName":"Precancerous Conditions", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" } ] } } } } } }