Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening
Launched by MAHIDOL UNIVERSITY · Jan 21, 2024

Apply for Trial

Nctid: NCT06231914

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D003483", "term"=>"Cutis Laxa"}], "ancestors"=>[{"id"=>"D012873", "term"=>"Skin Diseases, Genetic"}, {"id"=>"D030342", "term"=>"Genetic Diseases, Inborn"}, {"id"=>"D003240", "term"=>"Connective Tissue Diseases"}, {"id"=>"D012871", "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"}}}}

Edit this trial

Back to trials

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a special type of laser, called the fractional 1064-nm picosecond laser, to help tighten facial skin. Researchers want to find out how well this treatment reduces wrinkles, improves skin elasticity, and enhances overall skin texture and appearance. Participants in the study will receive three laser treatment sessions, each spaced four weeks apart, and will have follow-up visits at one, three, and six months after their last session to see how their skin has changed.

To be eligible for this trial, participants should be between 40 and 55 years old, have a body mass index (BMI) of less than 25, and have mild to moderate skin laxity. They should also be of Asian descent. However, individuals who are pregnant or breastfeeding, have had certain skin treatments in the past six months, have active skin infections, or have a history of severe scarring are not eligible. Overall, this trial aims to provide valuable information about a new treatment option for those looking to improve their facial skin.

Gender

ALL

Eligibility criteria

Inclusion Criteria:
• Aged 40-55 years
• BMI \< 25 kg/m2
• Asian
• Mild to moderate facial skin laxity using quantitative grading scale (grade 1.5-2.5)
Exclusion Criteria:
• Pregnant or lactation
• Subjects who have been treated with any kind of energy-based device 6 months prior to the inclusion
• Subjects who have been injected with botulinum toxin, filler, or platelet-rich plasma on their faces 6 months prior to the inclusion
• Active skin infections
• History of hypertrophic scars or keloids

Trial Officials

Woraphong Manuskiatti, MD

Principal Investigator

Mahidol University

About Mahidol University

Mahidol University, a premier institution in Thailand, is dedicated to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the university leverages its extensive expertise in medical and health sciences to facilitate rigorous scientific investigations aimed at improving patient care and public health outcomes. With a commitment to ethical practices and collaboration, Mahidol University fosters multidisciplinary approaches, engaging a diverse array of researchers and healthcare professionals to drive meaningful advancements in clinical research.

Locations

Bangkok, , Thailand

People applied

0 patients applied

Timeline

First submit

January 09, 2024

Trial launched

December 01, 2023

Trial updated

January 21, 2024

Estimated completion

Not reported

Discussion 0

Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening Launched by MAHIDOL UNIVERSITY · Jan 21, 2024

Frequently Asked Questions About Clinical Trials

Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening
Launched by MAHIDOL UNIVERSITY · Jan 21, 2024