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.
Study 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
Sex
ALL
Min age
30 Years
Max age
—
Healthy volunteers
Accepted
-Inclusion Criteria:
Men and women aged 30 years and older
Good general health, no relevant pre-existing conditions
Patients planning to undergo PLLA or CAHA 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
Primary outcome measure(s)
Inflammatory Reaction — From enrollment to the end of treatment at 6-8 week The effectiveness of biostimulatory treatments relies on inducing a localized inflammatory response. Ultrasound can be used to assess vascular dynamics and edema, serving as objective markers of inflammation.
Analysis of Injected Biostimulator-Deposits — From enrollment to the end of treatment at 6 -8 week Injected deposits: In the CaHa and PLLA treatment groups, deposits will be visualized via sonographic imaging, a 3-distance Volume measurement will be performed
Tissue Interaction — From enrollment to the end of treatment at 6-8 weeks Characterized through ultrasound, focusing on the visualization of the epidermis, dermis, superficial fat layer, fibrous layer (fascia/superficial musculoaponeurotic system), deep fat layer, and periosteum.
Adverse Events — From enrollment to the end of treatment at 6-8 week If AEs occur, they will be documented with photos and ultrasound, with appropriate treatment provided.
Trial sites (1)
Facility
City
Region
Status
University Hospital Hamburg Eppendorf
Hamburg
Free and Hanseatic City of Hamburg
Recruiting
More Universitätsklinikum Hamburg-Eppendorf trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.