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: * Recieve one of 3 possible biostumulatory treatments (PLLA/CAHA/RFM) * Attend 5 follow-up appointments after treatment for checkups, surveillance and examinations.
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: 1. PLLA (Sculptra®, Sinclair Pharmaceuticals) 2. CaHA (Radiesse®, Merz Pharma; HarmonyCa®, Allergan) 3. RFMN (Genius®, Lutronic Medical Systems) Treatment Protocols: * PLLA: 1-3 sessions at intervals of 4-6 weeks * CaHA: Single session * RFMN: 1-3 sessions at intervals of 6-8 weeks 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: 1. 6 weeks 2. 6 months 3. 12 months 4.18 months 5\. 24 months
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
90
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.
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.
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).
University Hospital Hamburg Eppendorf
Hamburg, Hamburg, Germany
RECRUITINGInflammatory 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 6-8 week
Clinical Outcome
Assessed using the Physician and Subject Global Aesthetic Improvement Scale (PGAIS, SGAIS) based on standardized photo documentation.
Time frame: From enrollment to the end of treatment at 6-8 week
Patient Satisfaction
Measured using a five-point Likert scale.
Time frame: From enrollment to the end of treatment at 6-8 week
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