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| ID | Type | Description | Link |
|---|---|---|---|
| University Hamburg Eppendorf | Other Identifier | Medicine Faculty - Clinic and Polyclinic for Dermatology and Venerology |
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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:
How is the Safety Profile of Biostimulatory Treatments? How are the Tissue Interactions after Biostiomulatory Treatments?
Participants will:
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.
Participants will be assigned to one of three treatment groups:
Treatment Protocols:
These interventions will follow routine clinical protocols, with more frequent follow-ups involving photography and ultrasound imaging as part of the study.
Follow-Up Assessments
Patients will undergo follow-up evaluations at 5 defined time points after treatment:
5. 24 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injectable Biostimulator 1 | Experimental | Injection to the face with a blunt canula |
|
| Injectable Biostimulator 2 | Experimental | Will be injected to the face with blunt canula |
|
| Energy-based Biostimulator | Experimental | 1-3 Treatments with 6-8 weeks of intervall |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poly-L-Lactic Acid (Sculptra) injection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Reaction | 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. | From enrollment to the end of treatment at 6-8 week |
| Analysis of Injected Biostimulator-Deposits | Injected deposits: In the CaHa and PLLA treatment groups, deposits will be visualized via sonographic imaging, a 3-distance Volume measurement will be performed | From enrollment to the end of treatment at 6 -8 week |
| Tissue Interaction | 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. | From enrollment to the end of treatment at 6-8 weeks |
| Adverse Events | If AEs occur, they will be documented with photos, ultrasound, and OCT, with appropriate treatment provided. | From enrollment to the end of treatment at 6-8 week |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome | Assessed using the Physician and Subject Global Aesthetic Improvement Scale (PGAIS, SGAIS) based on standardized photo documentation. | From enrollment to the end of treatment at 6-8 week |
| Patient Satisfaction |
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-Inclusion Criteria:
Men and women aged 30 years and older
Good general health, no relevant pre-existing conditions
Patients planning to undergo CaHa, PLLA, or RFMN treatment as part of routine care due to skin laxity or volume loss
Cognitive ability and willingness to provide informed consent
Willingness and ability to attend follow-up visits
-Exclusion Criteria:
Age under 30 years
Pregnant or breastfeeding individuals
Significant open wounds or lesions in the treatment area
Metallic implants in the treatment area
Psychiatric disorders (psychosis, body dysmorphic disorders)
Missing informed consent and/or data privacy declarations
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lynhda Nguyen, M.D. | Contact | +49 40 7410 - 54289 | l.nguyen@uke.de | |
| Katarina Herberger, MD. PHD. | Contact | +49 40 7410 - 54289 | k.herberger@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Jair Mauricio Ceron Bohorquez, M.D. | Medical Contour | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hamburg Eppendorf | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36972372 | Background | 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. | |
| 33954749 | Background | 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. |
| Label | URL |
|---|---|
| American Society of Plastic Surgeons Reveals 2022's Most Sought-After Procedures | View source |
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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.
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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.
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|
| Calcium Hydroxyapatite | Procedure | 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. |
|
| Radiofrequency Microneedling | Procedure | 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). |
|
Measured using a five-point Likert scale.
| From enrollment to the end of treatment at 6-8 week |
| 33954581 | Background | 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. |
| 26887446 | Background | 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. |
| 37563436 | Background | 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. |
| 25709485 | Background | 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. |
| 26766918 | Background | 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. |
| 25226004 | Result | 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. |
| ID | Term |
|---|---|
| C033616 | poly(lactide) |
| C482305 | New-Fill |
| D007267 | Injections |
| D017886 | Durapatite |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D006882 | Hydroxyapatites |
| D001031 | Apatites |
| D002130 | Calcium Phosphates |
| D010710 | Phosphates |
| D010756 | Phosphoric Acids |
| D017976 | Phosphorus Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D017610 | Calcium Compounds |
| D008903 | Minerals |
| D017553 | Phosphorus Compounds |
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