Clinical trial NCT06993558: Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators
Official title: Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers
Keywords: Ultrasound
Biostimulation
Poly-L-Lactic-Acid
Calcium-Hydroxylapatit
Radio Frequency Microneedling
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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

Eligibility 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

Primary outcomes:
measure: Inflammatory Reaction
timeFrame: From enrollment to the end of treatment at 6-8 week
measure: Analysis of Injected Biostimulator-Deposits
timeFrame: From enrollment to the end of treatment at 6 -8 week
measure: Tissue Interaction
timeFrame: From enrollment to the end of treatment at 6-8 weeks
measure: Adverse Events
timeFrame: From enrollment to the end of treatment at 6-8 week
Secondary outcomes:
measure: Clinical Outcome
timeFrame: From enrollment to the end of treatment at 6-8 week
measure: Patient Satisfaction
timeFrame: From enrollment to the end of treatment at 6-8 week
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hospital Hamburg Eppendorf
Study officials:
affiliation: Medical Contour
name: Jair Mauricio Ceron Bohorquez, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.