{ "FullStudy":{ "Rank":218013, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513863", "OrgStudyIdInfo":{ "OrgStudyId":"MTZG 1101" }, "Organization":{ "OrgFullName":"Taro Pharmaceuticals USA", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Therapeutic Equivalence Study of Two Metronidazole 1%Topical Gel Treatments for Patients With Rosacea", "OfficialTitle":"A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multi-Site Clinical Study to Compare the Bioequivalence of Two Metronidazole 1% Topical Gel Formulations in Patients With Moderate to Severe Rosacea", "Acronym":"MTZG" }, "StatusModule":{ "StatusVerifiedDate":"December 2013", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"August 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 16, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"December 19, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 23, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Taro Pharmaceuticals USA", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The objective of this study is to demonstrate that metronidazole 1% topical gel is effective for the treatment of patients with moderate to severe rosacea." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Rosacea" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"602", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Metronidazole Topical Gel 1%", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Metronidazole Topical Gel 1%" ] } },{ "ArmGroupLabel":"Metronidazole Topical Gel 1% (Metrogel )", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Metronidazole Topical Gel 1% (Metrogel)" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Metronidazole Topical Gel 1%", "InterventionDescription":"Metronidazole Topical Gel 1% applied to affected area once a day for 70 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Metronidazole Topical Gel 1%" ] } },{ "InterventionType":"Drug", "InterventionName":"Metronidazole Topical Gel 1% (Metrogel)", "InterventionDescription":"Metronidazole Topical Gel 1% applied to affected area once a day for 70 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Metronidazole Topical Gel 1% (Metrogel )" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"Placebo applied to affected area once a day for 70 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Clinical Success", "PrimaryOutcomeDescription":"A patient is considered a clinical success if the IGE is 0 (Clear)or 1 (Almost Clear)", "PrimaryOutcomeTimeFrame":"Day 70" },{ "PrimaryOutcomeMeasure":"Treatment Success", "PrimaryOutcomeDescription":"A patient is considered a treatment success if the mean percent change from baseline at week 10 (Day 70) in the inflammatory (papules and pastales) lesion count of Rosacea", "PrimaryOutcomeTimeFrame":"Day 70" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change in Investigational Global Evaluation (IGE)", "SecondaryOutcomeDescription":"Mean change from baseline to end of treatment in IGE", "SecondaryOutcomeTimeFrame":"Day 70" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMale or non-pregnant, non-lactating female, 18 years of age or older.\nSigned informed consent form, which meets all criteria of current FDA regulations.\nIf female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, transdermal, injected or implanted hormonal contraceptives).\nHave moderate to severe facial rosacea.\nHave a Baseline Investigator Global Evaluation Score of 3 or 4.\n\nExclusion Criteria:\n\nMild facial rosacea (less than 8 inflammatory lesions on the face) or very severe rosacea (more than 50 inflammatory lesions)\nPatients with excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with the diagnosis or assessment of rosacea.\nHistory of hypersensitivity or allergy to Metronidazole, or other ingredients of the formulation.\nUse of oral retinoids (e.g. Accutane ®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed) within the 6 months prior to the baseline visit.\n\nUse of the following within 1 month prior to the baseline visit:\n\nTopical Retinoids to the face\nSystemic antibiotics known to have an impact on the severity of facial Rosacea\nSystemic Steroids\nThe use of anticoagulant therapy within 14 days prior to baseline.\nThe use of any antipruritics, including antihistamines within 24 hours of any study visits.\nHistory of blood dyscrasia.\nOcular rosacea (e.g., conjunctivitis, blepharitis, keratitis) of sufficient severity to require topical or systemic antibiotics.\nAny dermatological condition other than rosacea that in the Investigator's opinion may interfere with the evaluation of the Patient's rosacea (e.g., acne, psoriasis, dermatitis).\nFemales who are pregnant, lactating or likely to become pregnant during the study.\nSignificant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study Patient at undue risk by participation.\nAny Patient (male or female) who has started, or changed hormonal therapy within 3 months of the Baseline visit (this includes hormonal contraceptives).\nUse of high strength (20% or above) alpha-hydroxy acid for facial peel or any type of chemical facial skin peel or other significant cosmetic procedures within 2 months of the study start.\nReceipt of any drug as part of a research study within 30 days prior to dosing.\nEmployees of the research center or Investigator.\nPrevious participation in this study.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"Investigator Site", "LocationCity":"Phoenix", "LocationState":"Arizona", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Long Beach", "LocationState":"California", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Newport Beach", "LocationState":"California", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Denver", "LocationState":"Colorado", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Jacksonville", "LocationState":"Florida", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Miami", "LocationState":"Florida", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Miramar", "LocationState":"Florida", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Arlington Heights", "LocationState":"Illinois", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Plainfield", "LocationState":"Indiana", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Henderson", "LocationState":"Nevada", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Hickory", "LocationState":"North Carolina", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"High Point", "LocationState":"North Carolina", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Wilmington", "LocationState":"North Carolina", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"South Euclid", "LocationState":"Ohio", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Hazelton", "LocationState":"Pennsylvania", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Simpsonville", "LocationState":"South Carolina", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Kingsport", "LocationState":"Tennessee", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Knoxville", "LocationState":"Tennessee", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Nashville", "LocationState":"Tennessee", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"San Antonio", "LocationState":"Texas", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"Webster", "LocationState":"Texas", "LocationCountry":"United States" },{ "LocationFacility":"Investigator Site", "LocationCity":"West Jordan", "LocationState":"Utah", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000008795", "InterventionMeshTerm":"Metronidazole" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" },{ "InterventionAncestorId":"D000000900", "InterventionAncestorTerm":"Anti-Bacterial Agents" },{ "InterventionAncestorId":"D000000981", "InterventionAncestorTerm":"Antiprotozoal Agents" },{ "InterventionAncestorId":"D000000977", "InterventionAncestorTerm":"Antiparasitic Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M10350", "InterventionBrowseLeafName":"Metronidazole", "InterventionBrowseLeafAsFound":"Metronidazole", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2803", "InterventionBrowseLeafName":"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2879", "InterventionBrowseLeafName":"Antiprotozoal Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2875", "InterventionBrowseLeafName":"Antiparasitic Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000012393", "ConditionMeshTerm":"Rosacea" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012871", "ConditionAncestorTerm":"Skin Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M13797", "ConditionBrowseLeafName":"Rosacea", "ConditionBrowseLeafAsFound":"Rosacea", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14257", "ConditionBrowseLeafName":"Skin Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }