Analysis of Safety and Tissue Interaction of Injectable Biosmulators
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorUniversitätsklinikum Hamburg-Eppendorf
About this trial
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
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Poly-L-Lactic Acid (Sculptra) injection
Procedure/Surgery1 to 2 sessions at intervals of 4 to 6 weeks are planned with PLLA (Sculptra®, Galderma Laboratories). PLLA will be injected into the face or neck region using a blunt cannula. For reconstitution, 7 ml of saline solution and 1 ml of 1 % lidocaine will be used. 5 minutes of massaging for 5 times a day are recommended.
Calcium Hydroxyapatite
Procedure/SurgeryFor CaHA treatment (Radiesse®, Merz Pharma; HarmonyCa®, Allergan), 1 session is planned. The face (cheeks, jawline) or neck will be augmented using a blunt cannula, either diluted (Radiesse® 1:0.2 - 1:2) or undiluted (HarmonyCA®) depending on the product and the region being treated.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Injectable Biostimulator 1Experimental treatment 1 intervention
Group B: Injectable Biostimulator 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Inflammatory Reaction
The effectiveness of biostimulatory treatments relies on inducing a localized inflammatory response. Ultrasound can be used to assess vascular dynamics and edema, serving as objective markers of inflammation.
Time frame
From enrollment to the end of treatment at 6-8 week2
Analysis of Injected Biostimulator-Deposits
Injected deposits: In the CaHa and PLLA treatment groups, deposits will be visualized via sonographic imaging, a 3-distance Volume measurement will be performed
Time frame
From enrollment to the end of treatment at 6 -8 week3
Tissue Interaction
Characterized through ultrasound, focusing on the visualization of the epidermis, dermis, superficial fat layer, fibrous layer (fascia/superficial musculoaponeurotic system), deep fat layer, and periosteum.
Time frame
From enrollment to the end of treatment at 6-8 weeks4
Adverse Events
If AEs occur, they will be documented with photos and ultrasound, with appropriate treatment provided.
Time frame
From enrollment to the end of treatment at 6-8 weekSecondary outcomes
1
Clinical Outcome
Assessed using the Physician and Subject Global Aesthetic Improvement Scale (PGAIS, SGAIS) based on standardized 3D photo documentation.
Time frame
From enrollment to the end of treatment at 6-8 week2
Patient Satisfaction
Measured using a five-point Likert scale.
Time frame
From enrollment to the end of treatment at 6-8 weekSponsors and contacts
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Source ClinicalTrials.gov