NCT06993558

Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators

Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.
PROCEDURE	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).

Timeline

• Start date: 2025-03-22
• Primary completion: 2026-03-22
• Completion: 2026-09-22
• First posted: 2025-05-29
• Last updated: 2025-05-29

Locations

1 site across 1 country: Germany