RecruitingNot ApplicableNCT06993558

Analysis of Safety and Tissue Interaction of Injectable Biosmulators

Analysis of Safety and Tissue Interaction of Injectable Biosmulators.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrollment

90 participants

Start Date

Jul 31, 2025

Study Type

INTERVENTIONAL

Conditions

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

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) biostimulatory interventions in healthy volunteers. The main questions it aims to answer are: How is the Safety Profile of injectable Biostimulatory Treatments? How are the Tissue Interactions after injectable Biostiomulatory Treatments? Participants will: * Recieve one of 2 possible biostumulatory treatments (PLLA/CAHA/ * Attend 4 follow-up appointments after treatment for checkups, surveillance and examinations.

Eligibility

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Calcium Hydroxyapatite and a procedure called Poly-L-Lactic Acid (Sculptra) injection for people with this study aims to evaluate the safety profile and tissue changes after biostimulatory treatments to the face in healthy volunteers. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPoly-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.

PROCEDURECalcium 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.

Locations(1)

University Hospital Hamburg Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, Germany

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NCT06993558