Nctid:
NCT06228833
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21089", "name"=>"Facies", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>50}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-01-30", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-10-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-18", "studyFirstSubmitDate"=>"2024-01-18", "studyFirstSubmitQcDate"=>"2024-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-03-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Global aesthetic improvement scale (GAIS) score", "timeFrame"=>"at day 90 after procedure", "description"=>"Investigator Satisfaction Assessment Form. Scoring criteria: 3 (very much improved), 2 (marked improvement), 1 (improved), 0 (no change), or -1 (worse)."}], "secondaryOutcomes"=>[{"measure"=>"Global aesthetic improvement scale (GAIS) score", "timeFrame"=>"at 30, 60 days after procedure", "description"=>"Investigator Satisfaction Assessment Form. Scoring criteria: 3 (very much improved), 2 (marked improvement), 1 (improved), 0 (no change), or -1 (worse)."}, {"measure"=>"Improvement of skin glossiness", "timeFrame"=>"at 30, 60, 90 days after procedure", "description"=>"Skin glossiness was assessed by an independent investigator on both sides of the face (three measurements averaged) according to DermaLab ® Combo (Multipurpose Skin Detector, Cortex) + Chromaticity Test Probe"}, {"measure"=>"Improvement in skin elasticity and tightness", "timeFrame"=>"at 30, 60, 90 days after procedure", "description"=>"Skin elasticity was assessed by an independent investigator on both sides of the face (averaged over three measurements) according to the DermaLab ® Combo + Elastic Probe"}, {"measure"=>"Improvement in dermal thickness/density", "timeFrame"=>"at 30, 60, 90 days after procedure", "description"=>"Dermal thickness/density was assessed on both sides of the face (averaged over three measurements) by an independent investigator using the DermaLab ® Combo + HF ultrasound probe"}, {"measure"=>"Improvement of transepidermal water loss (TEWL)", "timeFrame"=>"at 30, 60, 90 days after procedure", "description"=>"TEWL was assessed by an independent investigator on both sides of the face (three measurements averaged) according to the DermaLab ® Combo + TEWL test probe"}, {"measure"=>"Improvement of skin stratum corneum water content", "timeFrame"=>"at 30, 60, 90 days after procedure", "description"=>"Skin stratum corneum moisture was assessed on both sides of the face (three measurements averaged) by an independent investigator using the DermaLab ® Combo + Moisture Testing Probe"}, {"measure"=>"Improvement in fine lines score", "timeFrame"=>"at 30, 60, 90 days after procedure", "description"=>"Skin Parameter Assessment Form. Fine lines: Grading was performed on a Griffith 's scale (10-point scale) with different scores representing: 0 (no fine lines/wrinkles, skin completely smooth and no wrinkles); 1-3 (mild, few fine lines and wrinkles, and distant intervals within the treatment area); 4-6 (moderate, moderate number of fine lines/wrinkles within the treatment area and close to each other); and 7-9 (severe, dense clusters of fine lines/wrinkles within the treatment area). Fine lines status should be evaluated by an independent investigator."}, {"measure"=>"Subject satisfaction evaluation", "timeFrame"=>"at 30, 60, 90 days after procedure", "description"=>"Subject Satisfaction Assessment Form. 1: very dissatisfied, 2: dissatisfied, 3: fair, 4: satisfied, and 5: very satisfied, and the proportion of people in each rating was statistically summarized"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Skin Aging"]}, "descriptionModule"=>{"briefSummary"=>"A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and safety of monopolar radiofrequency combined with SkinCeuticals A.G.E and Skinceuticals CE FERULIC for improving facial skin elasticity, tightening and fading fine lines"}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"25 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Subjects must meet all of the following criteria to be enrolled in the study:\n\n 1. Healthy women, skin quality is not limited, aged 25 \\~ 65 years old face old \\~ moderate aging group;\n 2. subjects facial skin rough, loose, lack of elasticity;\n 3. Subjects with multiple facial fine lines, decree lines or puppet lines areas have static fine lines trend, the lower part showed signs of loosening;\n 4. Subjects with consistent facial skin status on both sides and planning to receive monopolar radiofrequency treatment;\n 5. Be able to cooperate well with the tester and maintain the regularity of life during the study;\n 6. Be able to read and understand all contents of the informed consent form, and voluntarily sign the informed consent form (ICF);\n 7. Agreed not to use any cosmetics, drugs and health products that have an impact on the results during the trial;\n\nExclusion Criteria:\n\n* Subjects were not included in the study if they met any of the following exclusion criteria:\n\n 1. Subjects with contraindications to monopolar radiofrequency treatment (such as malignant tumors, acute systemic infection, metal implants or active implants in the body such as cardiac pacemakers/defibrillators, etc.) or contraindications to A.G.E./CE use (or allergies to other skin care components);\n 2. Subjects with facial skin diseases, infections, inflammation, etc. that may affect the judgment of the test results;\n 3. Subjects with hypertrophic scar or scar constitution;\n 4. Subjects who have experienced tightening medical treatment (Gemma, Fotona 4D, ultrasonic cannon, ultrasonic scalpel, gold microneedle, etc.) in the past 3 months;\n 5. Subjects who have oral and topical cosmetic products that may affect the study results within 2 weeks;\n 6. Subjects who participate in drug clinical trials or other trials within 30 days, or subjects who have systemic use of drugs that may affect the study results within the past 1 week;\n 7. Pregnant or lactating women, or recent plans to prepare for pregnancy;\n 8. Other subjects who are not suitable for participating in this study as assessed by the investigator."}, "identificationModule"=>{"nctId"=>"NCT06228833", "briefTitle"=>"A Clinical Study to Evaluate the Efficacy and Safety of Monopolar Radiofrequency Combined With SkinCeuticals A.G.E and Skinceuticals CE FERULIC for Improving Facial Skin Elasticity, Tightening and Fading Fine Lines", "organization"=>{"class"=>"OTHER", "fullName"=>"Yes Skin Medical Group"}, "officialTitle"=>"A Prospective, Single-center, Single-blind, Randomized Split-face Controlled Clinical Study to Evaluate the Efficacy and Safety of Monopolar Radiofrequency Combined With SkinCeuticals A.G.E and Skinceuticals CE FERULIC for Improving Facial Skin Elasticity, Tightening and Fading Fine Lines", "orgStudyIdInfo"=>{"id"=>"SKCRFAGE002"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Test group", "interventionNames"=>["Device: monopolar radiofrequency", "Other: SkinCeuticals A.G.E and Skinceuticals CE FERULIC"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Control group", "interventionNames"=>["Device: monopolar radiofrequency", "Other: Standard Cream"]}], "interventions"=>[{"name"=>"monopolar radiofrequency", "type"=>"DEVICE", "description"=>"Each subject underwent monopolar radiofrequency treatment (Thermage FLX ™ ) on both sides of the face", "armGroupLabels"=>["Control group", "Test group"]}, {"name"=>"SkinCeuticals A.G.E and Skinceuticals CE FERULIC", "type"=>"OTHER", "description"=>"Test Side receives SkinCeuticals A.G.E and Skinceuticals CE FERULIC", "armGroupLabels"=>["Test group"]}, {"name"=>"Standard Cream", "type"=>"OTHER", "description"=>"Control Side applies Standard Cream", "armGroupLabels"=>["Control group"]}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Yes Skin Medical Group", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}