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Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Summary
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.
Official title: Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators.
Key Details
Gender
All
Age Range
30 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-03-22
Completion Date
2026-09-22
Last Updated
2025-05-29
Healthy Volunteers
Yes
Interventions
Poly-L-Lactic Acid (Sculptra) injection
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.
Calcium Hydroxyapatite
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
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).
Locations (1)
University Hospital Hamburg Eppendorf
Hamburg, Hamburg, Germany