Actively Recruiting
Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators
Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2025-05-29
90
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 30 years and older
- Good general health with no relevant pre-existing conditions
- Planning to undergo CaHA, PLLA, or RFMN treatment for skin laxity or volume loss
- Able to give informed consent
- Willing and able to attend follow-up visits
You will not qualify if you...
- Under 30 years of age
- Pregnant or breastfeeding
- Significant open wounds or lesions in treatment area
- Metallic implants in the treatment area
- Psychiatric disorders such as psychosis or body dysmorphic disorder
- Missing informed consent or data privacy declarations
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Hamburg Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
Actively Recruiting
Research Team
L
Lynhda Nguyen, M.D.
CONTACT
K
Katarina Herberger, MD. PHD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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