NCT Number: NCT06993558
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.
Interested in participating?
Request Info30 year and older
All sexes
Interventional
Not applicable
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
Location status: Recruiting
Jair Mauricio Ceron Bohorquez, M.D.
SUB_INVESTIGATOR
Katarina Herberger, M.D. PHD
CONTACT
Lynhda Nguyen, M.D.
CONTACT
Regular outclinic 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 2 treatment groups:
Treatment Protocols:
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 3 defined time points after treatment:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
-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
1 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.
For 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.
Time frame: From enrollment to the end of treatment at 6-8 week
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 week
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 weeks
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 week
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 week
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 week
Measured using a five-point Likert scale.
Contact information is provided by the study sponsor or research team.
Katarina Herberger, MD. PHD.
CONTACT
Lynhda Nguyen, M.D.
CONTACT
Universitätsklinikum Hamburg-Eppendorf
Other
Analysis of Safety and Tissue Interaction of Injectable Biosmulators.
Acronym: Biostimulation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
