MedTrace Logo

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

NCT06993558 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-05-29

No results posted yet for this study

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

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.

PROCEDURE

Radiofrequency 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 & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Jair Mauricio Ceron Bohorquez, M.D. · Medical Contour

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-22
Primary Completion
2026-03-22
Completion
2026-09-22

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06993558 on ClinicalTrials.gov