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Analysis of Safety and Tissue Interaction of Injectable Biosmulators

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

Last updated 2026-07-15

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) 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.

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.

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
2025-07-31
Primary Completion
2026-07-31
Completion
2027-09-15

Countries

  • Germany

Study Locations

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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