Nctid:
NCT06231914
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003483", "term"=>"Cutis Laxa"}], "ancestors"=>[{"id"=>"D000012873", "term"=>"Skin Diseases, Genetic"}, {"id"=>"D000030342", "term"=>"Genetic Diseases, Inborn"}, {"id"=>"D000003240", "term"=>"Connective Tissue Diseases"}, {"id"=>"D000012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M21089", "name"=>"Facies", "relevance"=>"LOW"}, {"id"=>"M6692", "name"=>"Cutis Laxa", "asFound"=>"Laxity; Skin", "relevance"=>"HIGH"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M15676", "name"=>"Skin Diseases, Genetic", "relevance"=>"LOW"}, {"id"=>"M23686", "name"=>"Genetic Diseases, Inborn", "relevance"=>"LOW"}, {"id"=>"M6464", "name"=>"Connective Tissue Diseases", "relevance"=>"LOW"}, {"id"=>"T1692", "name"=>"Cutis Laxa", "asFound"=>"Laxity; Skin", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-12-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-03-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-21", "studyFirstSubmitDate"=>"2024-01-09", "studyFirstSubmitQcDate"=>"2024-01-21", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The changes in wrinkle.", "timeFrame"=>"4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.", "description"=>"The changes in indentation of wrinkle using Antera (mm3)"}, {"measure"=>"The changes in nasolabial fold.", "timeFrame"=>"4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.", "description"=>"The changes in nasolabial fold using Quantificare (mm3)"}, {"measure"=>"The changes in skin laxity.", "timeFrame"=>"4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.", "description"=>"The changes in skin laxity using Quantificare (mm3)"}, {"measure"=>"The changes in skin elasticity.", "timeFrame"=>"4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.", "description"=>"The changes in skin elasticity (R0, R2, R5) using Cutometer (%)"}], "secondaryOutcomes"=>[{"measure"=>"The changes in skin texture.", "timeFrame"=>"4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.", "description"=>"The measurement will be done using Antera (mm3)"}, {"measure"=>"The changes in pore volume.", "timeFrame"=>"4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.", "description"=>"The measurement will be done using Antera (mm3)"}, {"measure"=>"The change in melanin index and erythema index.", "timeFrame"=>"4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.", "description"=>"The measurement of bioengineering assessment including melanin index and erythema index using Mexameter (%)"}, {"measure"=>"The change in sebum level.", "timeFrame"=>"4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.", "description"=>"The change in sebum production using Sebumeter (%)"}, {"measure"=>"Adverse events", "timeFrame"=>"4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.", "description"=>"Adverse events that occurred during the study protocol"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"conditions"=>["Laxity; Skin"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to learn the efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening. The main questions it aims to answer are:\n\n* Efficacy of fractional 1064-nm picosecond laser for facial skin efficacy including the changes in wrinkle, nasolabial fold, skin laxity, and skin elasticity\n* The changes in texture and pore volume using Antera\n* The changes in bioengineering assessment: melanin index, erythema index, sebum level\n* Adverse events Participants will be treated with 3 sessions of fractional 1064-nm picosecond laser (full face 4 passes, vector lines 4 passes), spaced 4 weeks apart. Follow-up visits 1, 3, and 6 months after the last treatments.", "detailedDescription"=>"The efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening in participants aged 40 to 55 years, BMI \\< 25 kg/m2, and have mild to moderate facial laxity."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"55 years", "minimumAge"=>"40 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Aged 40-55 years\n* BMI \\< 25 kg/m2\n* Asian\n* Mild to moderate facial skin laxity using quantitative grading scale (grade 1.5-2.5)\n\nExclusion Criteria:\n\n* Pregnant or lactation\n* Subjects who have been treated with any kind of energy-based device 6 months prior to the inclusion\n* Subjects who have been injected with botulinum toxin, filler, or platelet-rich plasma on their faces 6 months prior to the inclusion\n* Active skin infections\n* History of hypertrophic scars or keloids"}, "identificationModule"=>{"nctId"=>"NCT06231914", "briefTitle"=>"Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening", "organization"=>{"class"=>"OTHER", "fullName"=>"Mahidol University"}, "officialTitle"=>"Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening", "orgStudyIdInfo"=>{"id"=>"Si 981/2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Fractional 1064-nm Picosecond laser", "description"=>"Fractional 1064-nm Picosecond laser for 3 sessions, at 4-week interval", "interventionNames"=>["Device: StarWalker® PQX"]}], "interventions"=>[{"name"=>"StarWalker® PQX", "type"=>"DEVICE", "description"=>"Third-generation ASP-powered technology for ultra performance: Highest pico power \\& energy, shortest pico pulse width, wide range of laser wavelengths, exceptional spot size capabilities, largest fluence spectrum for flat-top handpieces", "armGroupLabels"=>["Fractional 1064-nm Picosecond laser"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"10700", "city"=>"Bangkok", "status"=>"RECRUITING", "country"=>"Thailand", "contacts"=>[{"name"=>"Woraphong Manuskiatti, M.D.", "role"=>"CONTACT", "email"=>"doctorlaser@gmail.com", "phone"=>"66869898613"}, {"name"=>"Woraphong Manuskiatti, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Supisara Wongdama, M.D.", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"Department of Dermatology, Siriraj Hospital, Mahidol University", "geoPoint"=>{"lat"=>13.75398, "lon"=>100.50144}}], "centralContacts"=>[{"name"=>"Woraphong Manuskiatti, MD", "role"=>"CONTACT", "email"=>"doctorlaser@gmail.com", "phone"=>"6624194333"}, {"name"=>"Supisara Wongdama, MD", "role"=>"CONTACT", "email"=>"popsupdm@gmail.com", "phone"=>"66869898613"}], "overallOfficials"=>[{"name"=>"Woraphong Manuskiatti, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Mahidol University"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Mahidol University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Prof. Dr.", "investigatorFullName"=>"Woraphong Manuskiatti, M.D.", "investigatorAffiliation"=>"Mahidol University"}}}}
