Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT07261527
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterization of Skin and Facial Fat Pad Thickness Changes Following Microneedling Radiofrequency With and Without Topical Poly-L-Lactic Acid for Facial Rejuvenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-22', 'studyFirstSubmitDate': '2025-11-22', 'studyFirstSubmitQcDate': '2025-11-22', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in subcutaneous fat pad thickness as measured by high-frequency ultrasound imaging', 'timeFrame': 'Baseline, 6 months'}], 'secondaryOutcomes': [{'measure': 'Difference in fat pad thickness between the RF+PLLA side and RF-only side as assessed by ultrasound imaging', 'timeFrame': '6 months'}, {'measure': 'Patient reported overall improvement in appearance as assessed by the Global Aesthetic Scale', 'timeFrame': '6 months', 'description': 'This is scored on a 5 point scale from 1(much worse) to 5 (much improved) , higher score indicating better outcome'}, {'measure': 'Change in satisfaction with forehead as assessed by the patient questionnaire', 'timeFrame': 'Baseline, 6 months', 'description': 'This is scored from 1 (lowest) to 10 (highest)'}, {'measure': 'Change in satisfaction with cheek as assessed by the patient questionnaire', 'timeFrame': 'Baseline, 6 months', 'description': 'This is scored from 1 (lowest) to 9 (highest)'}, {'measure': 'Change in satisfaction with submental as assessed by the patient questionnaire', 'timeFrame': 'Baseline, 6 months', 'description': 'This is scored from 1 (lowest) to 9 (highest)'}, {'measure': 'Change in overall social confidence as assessed by the patient questionnaire', 'timeFrame': 'Baseline, 6 months', 'description': 'This is scored from 1 (lowest) to 10 (highest)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Skin Texture']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether microneedling RF subcutaneous fat pad thickness in the temple, submental, and cheek regions, to determine whether the addition of topical PLLA after microneedling RF alters or preserves subcutaneous fat pad thickness and to assess patient satisfaction and perceived outcomes following microneedling RF ± PLLA treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Seeking facial rejuvenation for cosmetic concerns\n* Able and willing to provide informed consent\n* Willing to comply with study procedures and follow-up visits\n\nExclusion Criteria:\n\n* Prior filler injection or energy-based device treatment to the face within the past 6 months\n* Previous facial surgeries\n* Pregnant or breastfeeding\n* Active infection, dermatitis, or open lesions in the treatment area\n* History of keloids or abnormal scarring\n* Known allergy to poly-L-lactic acid (PLLA)- Current participation in another clinical trial involving facial aesthetic treatments\n* Presence of pre-cancerous or cancerous lesions in the treatment area\n* Current or planned use of glucagon-like peptide-1 receptor agonists (e.g., Ozempic, semaglutide) during the study period. Subjects on these medications will be excluded due to potential effects on facial fat and overall weight.\n* HIV+ patients\n* Patients on HIV medications- Patients that have eczema and rosacea'}, 'identificationModule': {'nctId': 'NCT07261527', 'briefTitle': 'Characterization of Skin and Facial Fat Pad Thickness Changes Following Microneedling Radiofrequency With and Without Topical Poly-L-Lactic Acid for Facial Rejuvenation', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Characterization of Skin and Facial Fat Pad Thickness Changes Following Microneedling Radiofrequency With and Without Topical Poly-L-Lactic Acid for Facial Rejuvenation', 'orgStudyIdInfo': {'id': 'HSC-MS-25-0585'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'microneedling radiofrequency (RF)', 'interventionNames': ['Device: microneedling RF treatment']}, {'type': 'NO_INTERVENTION', 'label': 'no treatment'}, {'type': 'EXPERIMENTAL', 'label': 'microneedling RF treatment with topical poly-L-lactic acid (PLLA)', 'interventionNames': ['Device: microneedling RF treatment', 'Device: PLLA']}, {'type': 'EXPERIMENTAL', 'label': 'microneedling RF treatment with placebo', 'interventionNames': ['Device: microneedling RF treatment', 'Drug: Sterile Water as control']}], 'interventions': [{'name': 'microneedling RF treatment', 'type': 'DEVICE', 'description': 'Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart', 'armGroupLabels': ['microneedling RF treatment with placebo', 'microneedling RF treatment with topical poly-L-lactic acid (PLLA)', 'microneedling radiofrequency (RF)']}, {'name': 'PLLA', 'type': 'DEVICE', 'description': 'Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by PLLA application after each treatment', 'armGroupLabels': ['microneedling RF treatment with topical poly-L-lactic acid (PLLA)']}, {'name': 'Sterile Water as control', 'type': 'DRUG', 'description': 'Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by sterile water application after each treatment', 'armGroupLabels': ['microneedling RF treatment with placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Ying Chen, MD', 'role': 'CONTACT', 'email': 'ying.chen@uth.tmc.edu', 'phone': '(713) 486-9400'}, {'name': 'Robert C Tung', 'role': 'CONTACT', 'email': 'Robert.C.Tung@uth.tmc.edu', 'phone': '(713) 486-6095'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Ying Chen, MD', 'role': 'CONTACT', 'email': 'ying.chen@uth.tmc.edu', 'phone': '(713) 486-9400'}, {'name': 'Robert C Tung', 'role': 'CONTACT', 'email': 'Robert.C.Tung@uth.tmc.edu', 'phone': '(713) 486-6095'}], 'overallOfficials': [{'name': 'Ying Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ying Chen', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}