Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06993558
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2025-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C033616', 'term': 'poly(lactide)'}, {'id': 'C482305', 'term': 'New-Fill'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D017886', 'term': 'Durapatite'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006882', 'term': 'Hydroxyapatites'}, {'id': 'D001031', 'term': 'Apatites'}, {'id': 'D002130', 'term': 'Calcium Phosphates'}, {'id': 'D010710', 'term': 'Phosphates'}, {'id': 'D010756', 'term': 'Phosphoric Acids'}, {'id': 'D017976', 'term': 'Phosphorus Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D017553', 'term': 'Phosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Healthy patients scheduled for biostimulatory treatment (one of three different modalities) at the outpatient clinic will be enrolled in the study. Upon completion of the treatment protocol, participants will undergo a series of follow-up visits. These follow-ups will include standardized 3D photographic documentation, ultrasound assessments, as well as both patient-reported outcome measures and physician-administered evaluations/questionnaires.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-09-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammatory Reaction', 'timeFrame': 'From enrollment to the end of treatment at 6-8 week', 'description': 'The effectiveness of biostimulatory treatments relies on inducing a localized inflammatory response. Ultrasound and optical coherence tomography (OCT) can be used to assess vascular dynamics and edema, serving as objective markers of inflammation.'}, {'measure': 'Analysis of Injected Biostimulator-Deposits', 'timeFrame': 'From enrollment to the end of treatment at 6 -8 week', 'description': 'Injected deposits: In the CaHa and PLLA treatment groups, deposits will be visualized via sonographic imaging, a 3-distance Volume measurement will be performed'}, {'measure': 'Tissue Interaction', 'timeFrame': 'From enrollment to the end of treatment at 6-8 weeks', 'description': 'Characterized through ultrasound and OCT, focusing on the visualization of the epidermis, dermis, superficial fat layer, fibrous layer (fascia/superficial musculoaponeurotic system), deep fat layer, and periosteum.'}, {'measure': 'Adverse Events', 'timeFrame': 'From enrollment to the end of treatment at 6-8 week', 'description': 'If AEs occur, they will be documented with photos, ultrasound, and OCT, with appropriate treatment provided.'}], 'secondaryOutcomes': [{'measure': 'Clinical Outcome', 'timeFrame': 'From enrollment to the end of treatment at 6-8 week', 'description': 'Assessed using the Physician and Subject Global Aesthetic Improvement Scale (PGAIS, SGAIS) based on standardized photo documentation.'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'From enrollment to the end of treatment at 6-8 week', 'description': 'Measured using a five-point Likert scale.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound', 'Biostimulation', 'Poly-L-Lactic-Acid', 'Calcium-Hydroxylapatit', 'Radio Frequency Microneedling'], 'conditions': ['This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '36972372', 'type': 'BACKGROUND', 'citation': 'Wortsman X, Quezada N, Penaloza O, Cavallieri F, Schelke L, Velthuis P. Ultrasonographic Patterns of Calcium Hydroxyapatite According to Dilution and Mix With Hyaluronic Acid. J Ultrasound Med. 2023 Sep;42(9):2065-2072. doi: 10.1002/jum.16226. Epub 2023 Mar 27.'}, {'pmid': '33954749', 'type': 'BACKGROUND', 'citation': 'Velthuis PJ, Jansen O, Schelke LW, Moon HJ, Kadouch J, Ascher B, Cotofana S. A Guide to Doppler Ultrasound Analysis of the Face in Cosmetic Medicine. Part 2: Vascular Mapping. Aesthet Surg J. 2021 Oct 15;41(11):NP1633-NP1644. doi: 10.1093/asj/sjaa411.'}, {'pmid': '33954581', 'type': 'BACKGROUND', 'citation': 'Velthuis PJ, Jansen O, Schelke LW, Moon HJ, Kadouch J, Ascher B, Cotofana S. A Guide to Doppler Ultrasound Analysis of the Face in Cosmetic Medicine. Part 1: Standard Positions. Aesthet Surg J. 2021 Oct 15;41(11):NP1621-NP1632. doi: 10.1093/asj/sjaa410.'}, {'pmid': '26887446', 'type': 'BACKGROUND', 'citation': 'Wortsman X, Alfageme F, Roustan G, Arias-Santiago S, Martorell A, Catalano O, Scotto di Santolo M, Zarchi K, Bouer M, Gonzalez C, Bard R, Mandava A, Gaitini D. Guidelines for Performing Dermatologic Ultrasound Examinations by the DERMUS Group. J Ultrasound Med. 2016 Mar;35(3):577-80. doi: 10.7863/ultra.15.06046. Epub 2016 Feb 17.'}, {'pmid': '37563436', 'type': 'BACKGROUND', 'citation': 'Kyriazidis I, Spyropoulou GA, Zambacos G, Tagka A, Rakhorst HA, Gasteratos K, Berner JE, Mandrekas A. Adverse Events Associated with Hyaluronic Acid Filler Injection for Non-surgical Facial Aesthetics: A Systematic Review of High Level of Evidence Studies. Aesthetic Plast Surg. 2024 Feb;48(4):719-741. doi: 10.1007/s00266-023-03465-1. Epub 2023 Aug 10.'}, {'pmid': '25709485', 'type': 'BACKGROUND', 'citation': 'Pavicic T. Complete biodegradable nature of calcium hydroxylapatite after injection for malar enhancement: an MRI study. Clin Cosmet Investig Dermatol. 2015 Feb 9;8:19-25. doi: 10.2147/CCID.S72878. eCollection 2015.'}, {'pmid': '26766918', 'type': 'BACKGROUND', 'citation': 'Amselem M. Radiesse((R)): a novel rejuvenation treatment for the upper arms. Clin Cosmet Investig Dermatol. 2015 Dec 29;9:9-14. doi: 10.2147/CCID.S93137. eCollection 2016.'}, {'pmid': '25226004', 'type': 'BACKGROUND', 'citation': 'Yutskovskaya Y, Kogan E, Leshunov E. A randomized, split-face, histomorphologic study comparing a volumetric calcium hydroxylapatite and a hyaluronic acid-based dermal filler. J Drugs Dermatol. 2014 Sep;13(9):1047-52.'}], 'seeAlsoLinks': [{'url': 'https://www.prnewswire.com/news-releases/american-society-of-plastic-surgeons-reveals-2022s-most-sought-after-procedures-301938919.html', 'label': "American Society of Plastic Surgeons Reveals 2022's Most Sought-After Procedures"}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to analyse tissue changes in the pre-auricular region after injectable (Poly-L-Lactic-Acid/Calcium-Hydroxylapatit/ and energy-based (Radiofrequency Microneedling) biostimulatory interventions in healthy volunteers. The main questions it aims to answer are:\n\nHow is the Safety Profile of Biostimulatory Treatments? How are the Tissue Interactions after Biostiomulatory Treatments?\n\nParticipants will:\n\n* Recieve one of 3 possible biostumulatory treatments (PLLA/CAHA/RFM)\n* Attend 5 follow-up appointments after treatment for checkups, surveillance and examinations.', 'detailedDescription': 'Patients undergoing biostimulatory treatments will be invited to participate in this study involving photographic evaluations and ultrasound imaging. Following detailed oral and written explanations, patients will provide informed consent.\n\nParticipants will be assigned to one of three treatment groups:\n\n1. PLLA (Sculptra®, Sinclair Pharmaceuticals)\n2. CaHA (Radiesse®, Merz Pharma; HarmonyCa®, Allergan)\n3. RFMN (Genius®, Lutronic Medical Systems)\n\nTreatment Protocols:\n\n* PLLA: 1-3 sessions at intervals of 4-6 weeks\n* CaHA: Single session\n* RFMN: 1-3 sessions at intervals of 6-8 weeks\n\nThese interventions will follow routine clinical protocols, with more frequent follow-ups involving photography and ultrasound imaging as part of the study.\n\nFollow-Up Assessments\n\nPatients will undergo follow-up evaluations at 5 defined time points after treatment:\n\n1. 6 weeks\n2. 6 months\n3. 12 months 4.18 months\n\n5\\. 24 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '-Inclusion Criteria:\n\nMen and women aged 30 years and older\n\nGood general health, no relevant pre-existing conditions\n\nPatients planning to undergo CaHa, PLLA, or RFMN treatment as part of routine care due to skin laxity or volume loss\n\nCognitive ability and willingness to provide informed consent\n\nWillingness and ability to attend follow-up visits\n\n-Exclusion Criteria:\n\nAge under 30 years\n\nPregnant or breastfeeding individuals\n\nSignificant open wounds or lesions in the treatment area\n\nMetallic implants in the treatment area\n\nPsychiatric disorders (psychosis, body dysmorphic disorders)\n\nMissing informed consent and/or data privacy declarations'}, 'identificationModule': {'nctId': 'NCT06993558', 'acronym': 'Biostimulation', 'briefTitle': 'Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators.', 'orgStudyIdInfo': {'id': '2024-101412-BO-ff'}, 'secondaryIdInfos': [{'id': 'University Hamburg Eppendorf', 'type': 'OTHER', 'domain': 'Medicine Faculty - Clinic and Polyclinic for Dermatology and Venerology'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injectable Biostimulator 1', 'description': 'Injection to the face with a blunt canula', 'interventionNames': ['Procedure: Poly-L-Lactic Acid (Sculptra) injection']}, {'type': 'EXPERIMENTAL', 'label': 'Injectable Biostimulator 2', 'description': 'Will be injected to the face with blunt canula', 'interventionNames': ['Procedure: Calcium Hydroxyapatite']}, {'type': 'EXPERIMENTAL', 'label': 'Energy-based Biostimulator', 'description': '1-3 Treatments with 6-8 weeks of intervall', 'interventionNames': ['Procedure: Radiofrequency Microneedling']}], 'interventions': [{'name': 'Poly-L-Lactic Acid (Sculptra) injection', 'type': 'PROCEDURE', 'description': '1 to 2 sessions at intervals of 4 to 6 weeks are planned with PLLA (Sculptra®, Galderma Laboratories). PLLA will be injected into the face or neck region using a blunt cannula. For reconstitution, 7 ml of saline solution and 1 ml of 1 % lidocaine will be used. 5 minutes of massaging for 5 times a day are recommended.', 'armGroupLabels': ['Injectable Biostimulator 1']}, {'name': 'Calcium Hydroxyapatite', 'type': 'PROCEDURE', 'description': 'For CaHA treatment (Radiesse®, Merz Pharma; HarmonyCa®, Allergan), 1 session is planned. The face (cheeks, jawline) or neck will be augmented using a blunt cannula, either diluted (Radiesse® 1:0.2 - 1:2) or undiluted (HarmonyCA®) depending on the product and the region being treated.', 'armGroupLabels': ['Injectable Biostimulator 2']}, {'name': 'Radiofrequency Microneedling', 'type': 'PROCEDURE', 'description': 'For RFMN treatment (Genius®, Lutronic Medical Systems), 1 to 3 sessions at intervals of 6 to 8 weeks are planned. Prior to treatment, subjects were given topical anesthesia (23% lidocaine, 3.5% tetracaine) under occlusion for at least 1.5 hours. The face will be treated with an RFMN system, using parameters adjusted for each anatomical location. Each region received three passes with 50 - 70 % overlap, starting with the longest needle setting. A minimum total energy of 1000 J will be aimed. Treatment will be performed using forced cooled air (Cryo6, Zimmer Aesthe cDivision).', 'armGroupLabels': ['Energy-based Biostimulator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'state': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Katarina Herberger, M.D. PHD', 'role': 'CONTACT', 'email': 'k.herberger@uke.de', 'phone': '+49 40 7410 - 54289'}, {'name': 'Lynhda Nguyen, M.D.', 'role': 'CONTACT', 'email': 'l.nguyen@uke.de', 'phone': '+49 40 7410 - 54289'}, {'name': 'Jair Mauricio Ceron Bohorquez, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Hamburg Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Lynhda Nguyen, M.D.', 'role': 'CONTACT', 'email': 'l.nguyen@uke.de', 'phone': '+49 40 7410 - 54289'}, {'name': 'Katarina Herberger, MD. PHD.', 'role': 'CONTACT', 'email': 'k.herberger@uke.de', 'phone': '+49 40 7410 - 54289'}], 'overallOfficials': [{'name': 'Jair Mauricio Ceron Bohorquez, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Contour'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual Participant Data (IPD) may not be shared due to concerns about participant privacy and data protection regulations, limitations in the original informed consent, intellectual property or commercial interests, and the significant resources required to prepare and anonymize the data. Additionally, ethical considerations and institutional or regulatory policies may further restrict data sharing to ensure participant confidentiality and prevent potential misuse.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.med. Lynhda Nguyen', 'investigatorFullName': 'Lynhda Nguyen', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}