Overview
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.
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:
- PLLA (Sculptra®, Sinclair Pharmaceuticals)
- CaHA (Radiesse®, Merz Pharma; HarmonyCa®, Allergan)
- 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:
- 6 weeks
- 6 months
- 12 months 4.18 months
- 24 months
Eligibility
-Inclusion Criteria:
Men and women aged 30 years and older
Good general health, no relevant pre-existing conditions
Patients planning to undergo CaHa, PLLA, or RFMN 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