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OpenTrials
Completed

NCT Number: NCT00877279

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

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.

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Key information

Conditions

Facial Wrinkles

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Skin Care & Laser Physicians of Beverly Hills, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CosmoDerm1

Device

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

Belotero Soft

Device

Dermal Filler

Primary outcomes

  1. The severity of the facial wrinkle

    Time frame: 2 weeks and 4 weeks

Secondary outcomes

  1. Investigator and subject assessments

    Time frame: 2 weeks and 4 weeks

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Registry information

Official study title

A Randomized,Blinded,Controlled,Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero® Soft, After Superficial to Mid Dermal Implantation for Correction of Mild Facial Wrinkles Over 4 Weeks.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 7, 2009
Registry last updated
Nov 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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