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Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds

NCT04647721 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2023-01-23

Study results available
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Summary

Effectiveness: The purpose of this study is to demonstrate the non-inferiority of Radiesse (CaHA) to Restylane (HA) following subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs.

Safety: To evaluate the incidence and type of adverse events and serious adverse events.

Conditions

  • Correction of Moderate to Severe Nasolabial Folds (NLFs)

Interventions

DEVICE

Radiesse injectable implant (dermal filler)

Subdermal injection.

DEVICE

Restylane injectable implant (dermal filler)

Subdermal injection.

Sponsors & Collaborators

  • Merz North America, Inc.

    lead INDUSTRY

Principal Investigators

  • Merz Medical Expert · Merz North America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2021-11-08
Completion
2022-04-27
FDA Device
Yes

Countries

  • China

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 NCT04647721 on ClinicalTrials.gov