Nctid:
NCT06616311
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008548", "term"=>"Melanosis"}], "ancestors"=>[{"id"=>"D000017495", "term"=>"Hyperpigmentation"}, {"id"=>"D000010859", "term"=>"Pigmentation Disorders"}, {"id"=>"D000012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M11531", "name"=>"Melanosis", "asFound"=>"Melasma", "relevance"=>"HIGH"}, {"id"=>"M19760", "name"=>"Hyperpigmentation", "relevance"=>"LOW"}, {"id"=>"M13754", "name"=>"Pigmentation Disorders", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "documentSection"=>{"largeDocumentModule"=>{"largeDocs"=>[{"date"=>"2024-06-07", "size"=>330989, "label"=>"Study Protocol", "hasIcf"=>false, "hasSap"=>false, "filename"=>"Prot_001.pdf", "typeAbbrev"=>"Prot", "uploadDate"=>"2024-10-02T11:10", "hasProtocol"=>true}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP", "interventionModelDescription"=>"Radiofrequency microneedling (RFMN) as a treatment for melasma"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>10}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-10", "completionDateStruct"=>{"date"=>"2026-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-10-02", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-03", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Treatment efficacy as determined by change in mMASI scoring of melasma severity post-treatment.", "timeFrame"=>"9 months", "description"=>"The primary endpoint is treatment efficacy as determined by change in mMASI scoring of melasma severity post-treatment."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"conditions"=>["Melasma"]}, "descriptionModule"=>{"briefSummary"=>"The objective of this study is to test the effectiveness of radiofrequency microneedling (RFMN) as a treatment for melasma. The Investigator hypothesize that RFMN will be an effective treatment for melasma in skin of color patients.", "detailedDescription"=>"The target population is skin of color patients with melasma. Patients will receive 3 consecutive RFMN treatments over a period of three months. Baseline melasma severity will be measured by the modified Melasma Area and Severity Index (mMASI) score. Endpoints will be mMASI scores at 1 and 3 months post-procedure. Patient reported outcomes will be measured using the melasma quality of life (MelasQOL) validated patient questionnaire at screening and at both follow up visits. The long-term goal of future studies would be to provide melasma patients, particularly those with skin of color, with improved therapeutic options for the treatment of their melasma, as compared to current treatment options."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Males or females, at least 18 years of age\n* Fitzpatrick skin types IV-VI\n* Clinically diagnosed melasma\n* No topicals (retinol, vitamin C serum, etc) for 6 weeks before Visit 1 (with exception of sunscreen)\n\nExclusion Criteria:\n\n* is currently pregnant or planning to conceive during the study period\n* is using topical or oral therapy or other treatment for melasma"}, "identificationModule"=>{"nctId"=>"NCT06616311", "acronym"=>"SylfirmX", "briefTitle"=>"Efficacy of Radiofrequency Micro Needling for the Treatment of Melasma in Skin of Color.", "organization"=>{"class"=>"OTHER", "fullName"=>"The Cleveland Clinic"}, "officialTitle"=>"A Prospective Study of the Efficacy of Radiofrequency Micro Needling for the Treatment of Melasma in Skin of Color.", "orgStudyIdInfo"=>{"id"=>"23-649"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Treatment", "description"=>"The target population is skin of color patients with melasma. Patients will receive 5 consecutive RFMN treatments over a period of 5 months.", "interventionNames"=>["Device: Radiofrequency microneedling"]}], "interventions"=>[{"name"=>"Radiofrequency microneedling", "type"=>"DEVICE", "description"=>"The target population is skin of color patients with melasma. Patients will receive 5 consecutive RFMN treatments over a period of 5 months.", "armGroupLabels"=>["Treatment"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Rothy Rim", "role"=>"CONTACT", "email"=>"rimr@ccf.org", "phone"=>"216-444-7277"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"The Cleveland Clinic", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Benev Company, Inc.", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Shilpi Khetarpal", "investigatorAffiliation"=>"The Cleveland Clinic"}}}}
