Analysis of Safety and Tissue Interaction of Injectable and Energy-based Biosmulators

NCT06993558 | Recruiting

• 2 other identifiers: 2024-101412-BO-ffUniversity Hamburg Eppendorf
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Inflammatory Reaction

  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.

  From enrollment to the end of treatment at 6-8 week

• 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

  From enrollment to the end of treatment at 6 -8 week

• Tissue Interaction

  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.

  From enrollment to the end of treatment at 6-8 weeks

• Adverse Events

  If AEs occur, they will be documented with photos, ultrasound, and OCT, with appropriate treatment provided.

  From enrollment to the end of treatment at 6-8 week

Secondary Outcomes (2)

• Clinical Outcome

  From enrollment to the end of treatment at 6-8 week

• Patient Satisfaction

  From enrollment to the end of treatment at 6-8 week

Study Arms (3)

Injectable Biostimulator 1

EXPERIMENTAL

Injection to the face with a blunt canula

Procedure: Poly-L-Lactic Acid (Sculptra) injection

Injectable Biostimulator 2

EXPERIMENTAL

Will be injected to the face with blunt canula

Procedure: Calcium Hydroxyapatite

Energy-based Biostimulator

EXPERIMENTAL

1-3 Treatments with 6-8 weeks of intervall

Procedure: Radiofrequency Microneedling

Interventions

Poly-L-Lactic Acid (Sculptra) injection PROCEDURE

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.

Injectable Biostimulator 1

Calcium Hydroxyapatite PROCEDURE

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.

Injectable Biostimulator 2

Radiofrequency Microneedling PROCEDURE

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).

Energy-based Biostimulator

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Hospital Hamburg Eppendorf

Hamburg, Hamburg, 20246, Germany

RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• American Society of Plastic Surgeons Reveals 2022's Most Sought-After Procedures

MeSH Terms

Interventions

poly(lactide); New-Fill; Injections; Durapatite

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Hydroxyapatites; Apatites; Calcium Phosphates; Phosphates; Phosphoric Acids; Phosphorus Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Calcium Compounds; Minerals; Phosphorus Compounds

Study Officials

• Jair Mauricio Ceron Bohorquez, M.D.

  Medical Contour

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynhda Nguyen, M.D.

CONTACT

+49 40 7410 - 54289; l.nguyen@uke.de

Katarina Herberger, MD. PHD.

CONTACT

+49 40 7410 - 54289; k.herberger@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med. Lynhda Nguyen

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 29, 2025
• Study Start: March 22, 2025
• Primary Completion: March 22, 2026
• Study Completion (Estimated): September 22, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

DE (1)