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

Merz North America, Inc.64 enrolled

Overview

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.

The purpose of the study is to see if Belotero® Soft is safe and effective for correction of mild facial wrinkles, such as nasolabial folds. The second objective of the study is to see if Belotero® Soft works better than the active comparator. Subjects will receive Belotero® Soft injection to one side of the face and the active comparator to the other side of the face.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Facial Wrinkles

Interventions

CosmoDerm1DEVICE

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

Belotero SoftDEVICE

Dermal Filler

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects must have bilateral facial wrinkles, such as nasolabial folds Exclusion Criteria: * Other nasolabial fold correction within 6 months prior to study entry.

Locations (5)

Skin Care & Laser Physicians of Beverly Hills

Los Angeles, California, United States

Maas Clinic

San Francisco, California, United States

Savin Dermatology Center

New Haven, Connecticut, United States

William Coleman, III, MD

Metairie, Louisiana, United States

Outcomes

Primary Outcomes

The severity of the facial wrinkle

Time frame: 2 weeks and 4 weeks

Secondary Outcomes

Investigator and subject assessments

Time frame: 2 weeks and 4 weeks

Data from ClinicalTrials.gov

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