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Multicenter Study of the Safety and Efficacy of Dermal Filler, Belotero® Soft

NCT00877279 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2013-11-15

No results posted yet for this study

Summary

This study is to determine the safety and effectiveness of Belotero® Soft compared to active comparator in the correction of mild facial wrinkles, such as nasolabial folds.

Conditions

  • Facial Wrinkles

Interventions

DEVICE

CosmoDerm1

CosmoDerm1 is a single use syringe, injected into the mid dermal layer.

DEVICE

Belotero Soft

Dermal Filler

Sponsors & Collaborators

  • Merz North America, Inc.

    lead INDUSTRY

Principal Investigators

  • Rhoda Narins, MD · Dermatology Surgery and Laser Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-03-31
Completion
2008-03-31

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 NCT00877279 on ClinicalTrials.gov