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Evaluation of the Merz Cheek Fullness Assessment Scale in the Treatment of Midface Volume Deficit

NCT03321825 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-01-19

No results posted yet for this study

Summary

Evaluation of the sensitivity of the Merz Cheeks Fullness Assessment Scale (MCFAS) and the clinical relevance of aesthetically pleasing outcomes by detecting changes in cheek appearance after Belotero® Volume Lidocaine injection.

The safety objectives include the identification and description of adverse events (AEs), adverse device effects (ADEs), serious adverse events (SAEs), serious adverse device effects (SADEs), anticipated serious adverse device effects (ASADEs) and unanticipated adverse device effects (UADEs) during the course of the study. Additionally, common treatment site responses (CTRs) will be assessed.

Conditions

  • Moderate to Severe Midface Volume Deficit

Interventions

DEVICE

Belotero® Volume Lidocaine

Mode of application: subdermal injection

Sponsors & Collaborators

  • Merz North America, Inc.

    lead INDUSTRY

Principal Investigators

  • Merz Scientific Expert · Merz Pharmaceuticals GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-29
Primary Completion
2018-01-08
Completion
2018-01-08

Countries

  • Canada

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 NCT03321825 on ClinicalTrials.gov