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NCT06993558
Analysis of Safety and Tissue Interaction of Injectable Biosmulators
Conditions: This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers
Sex: All
Ages: 30 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 90
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Location: University Hospital Hamburg Eppendorf Hamburg Free and Hanseatic City of Hamburg
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 Criteria
-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
Source: ClinicalTrials.gov (NCT06993558). StuddyBuddy aggregates publicly available trial information.