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Analysis of Safety and Tissue Interaction of Injectable Biosmulators

RecruitingNA

Sponsor: Universitätsklinikum Hamburg-Eppendorf

Conditions: This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers

Interventions: Poly-L-Lactic Acid (Sculptra) injection, Calcium Hydroxyapatite

Countries: Germany

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 overview

Sex: ALL

Age: 30 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (1)

Hamburg, Free and Hanseatic City of Hamburg, Germany