This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers
Conditions
Keywords
Ultrasound, Biostimulation, Poly-L-Lactic-Acid, Calcium-Hydroxylapatit, Radio Frequency Microneedling
Brief 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/ 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.
Detailed description
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 three treatment groups: 1. PLLA (Sculptra®, Sinclair Pharmaceuticals) 2. CaHA (Radiesse®, Merz Pharma; HarmonyCa®, Allergan) 3. RFMN (Genius®, Lutronic Medical Systems) Treatment Protocols: * PLLA: 1-3 sessions at intervals of 4-6 weeks * CaHA: Single session * RFMN: 1-3 sessions at intervals of 6-8 weeks 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 5 defined time points after treatment: 1. 6 weeks 2. 6 months 3. 12 months 4.18 months 5\. 24 months
Interventions
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.
PROCEDURECalcium Hydroxyapatite
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.
PROCEDURERadiofrequency Microneedling
For RFMN treatment (Genius®, Lutronic Medical Systems), 1 to 3 sessions at intervals of 6 to 8 weeks are planned. Prior to treatment, subjects were given topical anesthesia (23% lidocaine, 3.5% tetracaine) under occlusion for at least 1.5 hours. The face will be treated with an RFMN system, using parameters adjusted for each anatomical location. Each region received three passes with 50 - 70 % overlap, starting with the longest needle setting. A minimum total energy of 1000 J will be aimed. Treatment will be performed using forced cooled air (Cryo6, Zimmer Aesthe cDivision).
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Healthy patients scheduled for biostimulatory treatment (one of three different modalities) at the outpatient clinic will be enrolled in the study. Upon completion of the treatment protocol, participants will undergo a series of follow-up visits. These follow-ups will include standardized 3D photographic documentation, ultrasound assessments, as well as both patient-reported outcome measures and physician-administered evaluations/questionnaires.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
-Inclusion Criteria: Men and women aged 30 years and older Good general health, no relevant pre-existing conditions Patients planning to undergo CaHa, PLLA, or RFMN 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Reaction | From enrollment to the end of treatment at 6-8 week | The effectiveness of biostimulatory treatments relies on inducing a localized inflammatory response. Ultrasound and optical coherence tomography (OCT) can be used to assess vascular dynamics and edema, serving as objective markers of inflammation. |
| Analysis of Injected Biostimulator-Deposits | 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 |
| Tissue Interaction | From enrollment to the end of treatment at 6-8 weeks | Characterized through ultrasound and OCT, focusing on the visualization of the epidermis, dermis, superficial fat layer, fibrous layer (fascia/superficial musculoaponeurotic system), deep fat layer, and periosteum. |
| Adverse Events | From enrollment to the end of treatment at 6-8 week | If AEs occur, they will be documented with photos, ultrasound, and OCT, with appropriate treatment provided. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome | 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 photo documentation. |
| Patient Satisfaction | From enrollment to the end of treatment at 6-8 week | Measured using a five-point Likert scale. |
Countries
Germany
Contacts
Primary ContactLynhda Nguyen, M.D.
Backup ContactKatarina Herberger, MD. PHD.
Outcome results
None listed