Analysis of Safety and Tissue Interaction of Injectable Biosmulators
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Poly-L-Lactic Acid (Sculptra) injection, Calcium Hydroxyapatite.
- Who it may be relevant to
- Registry conditions: This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers. Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Analysis of Safety and Tissue Interaction of Injectable Biosmulators.
Overview
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.
Detailed description
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:
1. PLLA (Sculptra®, Sinclair Pharmaceuticals) 2. CaHA (Radiesse®, Merz Pharma)
Treatment Protocols:
* PLLA: 1-3 sessions at intervals of 4-6 weeks * CaHA: Single session
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:
1. 6 weeks 2. 6 months 3. 12 months
Interventions
- Procedure Poly-L-Lactic Acid (Sculptra) injection
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. - Procedure Calcium 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.
Primary outcome measures
- Inflammatory Reaction [Time frame: From enrollment to the end of treatment at 6-8 week]
- Analysis of Injected Biostimulator-Deposits [Time frame: From enrollment to the end of treatment at 6 -8 week]
- Tissue Interaction [Time frame: From enrollment to the end of treatment at 6-8 weeks]
- Adverse Events [Time frame: From enrollment to the end of treatment at 6-8 week]
Secondary outcome measures (2)
- Clinical Outcome [Time frame: From enrollment to the end of treatment at 6-8 week]
- Patient Satisfaction [Time frame: From enrollment to the end of treatment at 6-8 week]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Germany · 1 center
- University Hospital Hamburg Eppendorf — Hamburg
Publications
- Wortsman X, Quezada N, Penaloza O, Cavallieri F, Schelke L, Velthuis P. Ultrasonographic Patterns of Calcium Hydroxyapatite According to Dilution and Mix With Hyaluronic Acid. J Ultrasound Med. 2023 Sep;42(9):2065-2072. doi: 10.1002/jum.16226. Epub 2023 Mar 27. PMID 36972372
- Velthuis PJ, Jansen O, Schelke LW, Moon HJ, Kadouch J, Ascher B, Cotofana S. A Guide to Doppler Ultrasound Analysis of the Face in Cosmetic Medicine. Part 2: Vascular Mapping. Aesthet Surg J. 2021 Oct 15;41(11):NP1633-NP1644. doi: 10.1093/asj/sjaa411. PMID 33954749
- Velthuis PJ, Jansen O, Schelke LW, Moon HJ, Kadouch J, Ascher B, Cotofana S. A Guide to Doppler Ultrasound Analysis of the Face in Cosmetic Medicine. Part 1: Standard Positions. Aesthet Surg J. 2021 Oct 15;41(11):NP1621-NP1632. doi: 10.1093/asj/sjaa410. PMID 33954581
- Wortsman X, Alfageme F, Roustan G, Arias-Santiago S, Martorell A, Catalano O, Scotto di Santolo M, Zarchi K, Bouer M, Gonzalez C, Bard R, Mandava A, Gaitini D. Guidelines for Performing Dermatologic Ultrasound Examinations by the DERMUS Group. J Ultrasound Med. 2016 Mar;35(3):577-80. doi: 10.7863/ultra.15.06046. Epub 2016 Feb 17. PMID 26887446
- Kyriazidis I, Spyropoulou GA, Zambacos G, Tagka A, Rakhorst HA, Gasteratos K, Berner JE, Mandrekas A. Adverse Events Associated with Hyaluronic Acid Filler Injection for Non-surgical Facial Aesthetics: A Systematic Review of High Level of Evidence Studies. Aesthetic Plast Surg. 2024 Feb;48(4):719-741. doi: 10.1007/s00266-023-03465-1. Epub 2023 Aug 10. PMID 37563436
- Pavicic T. Complete biodegradable nature of calcium hydroxylapatite after injection for malar enhancement: an MRI study. Clin Cosmet Investig Dermatol. 2015 Feb 9;8:19-25. doi: 10.2147/CCID.S72878. eCollection 2015. PMID 25709485
- Amselem M. Radiesse((R)): a novel rejuvenation treatment for the upper arms. Clin Cosmet Investig Dermatol. 2015 Dec 29;9:9-14. doi: 10.2147/CCID.S93137. eCollection 2016. PMID 26766918
- Yutskovskaya Y, Kogan E, Leshunov E. A randomized, split-face, histomorphologic study comparing a volumetric calcium hydroxylapatite and a hyaluronic acid-based dermal filler. J Drugs Dermatol. 2014 Sep;13(9):1047-52. PMID 25226004
Identifiers
NCT: NCT06993558 · 2024-101412-BO-ff · University Hamburg Eppendorf