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Evaluation of Pain With Belotero® Balance With Integral Lidocaine for Correction of the Nasolabial Folds

NCT03319719 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2019-10-01

Study results available
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Summary

Demonstrate the effectiveness of Belotero Balance with lidocaine (Test group) for the reduction of injection-related pain in comparison to Belotero Balance without lidocaine (Control group) for the correction of NLFs.

Identify and describe adverse events (AEs) and serious adverse events (SAEs) during the course of the study. Additionally, common treatment site responses (CTRs) will be assessed.

Conditions

  • Correction of Moderate to Severe Nasolabial Folds

Interventions

DEVICE

Belotero® Balance with integral lidocaine

Mode of application: intradermal injection. Maximum treatment volume: 3 mL per nasolabial fold over two Treatment sessions.

DEVICE

Belotero® Balance

Mode of application: intradermal injection. Maximum treatment volume: 3 mL per nasolabial fold over two Treatment sessions.

Sponsors & Collaborators

  • Merz North America, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter Kreymerman, MD, FACS · Merz North America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2017-12-06
Completion
2017-12-06
FDA Device
Yes

Countries

  • United States

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 NCT03319719 on ClinicalTrials.gov