MedTrace Logo

Safety, Effectiveness and Participant Satisfaction Study of a Dermal Filler (of RADIESSE® (+) Lidocaine) in the Treatment of Ageing Signs in the Face

NCT03650387 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2023-12-05

Study results available
· View outcomes & findings →

Summary

The primary objective is to collect clinical data to confirm performance and safety for RADIESSE® (+) Lidocaine, when used in accordance with its labelling in the treatment of nasolabial folds, marionette lines and/or upper cheek volume loss.

Conditions

  • Signs of Facial Aging With Volume Loss in the Upper Cheeks, Nasolabial Folds and Marionette Lines

Interventions

DEVICE

RADIESSE® (+) Lidocaine

RADIESSE® (+) Lidocaine will be injected as per its current approved labelling and investigator's usual practice

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    collaborator INDUSTRY

  • Merz North America, Inc.

    lead INDUSTRY

Principal Investigators

  • Merz Medical Expert · Merz Pharmaceuticals GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2020-05-26
Completion
2020-05-26
FDA Device
Yes

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 NCT03650387 on ClinicalTrials.gov