Analysis of Safety and Tissue Interaction of Injectable Biosmulators.
Analysis of Safety and Tissue Interaction of Injectable Biosmulators.
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:
Regular outclinic 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 2 treatment groups:
Treatment Protocols:
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 3 defined time points after treatment:
-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
l.nguyen@uke.de+49 40 7410 - 54289
k.herberger@uke.de+49 40 7410 - 54289