Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds - Full Text View

Purpose

This is a randomized, double-blind study to evaluate the safety and effectiveness of CosmetaLife injectable dermal filler for the correction of wrinkles and folds, such as nasolabial folds (i.e., smile lines).

Condition	Intervention	Phase
Facial Wrinkles	Device: Injectable dermal filler	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double-Blind, Multicenter Comparison of the Safety and Efficacy of CosmetaLife™ Versus Control for the Correction of Nasolabial Folds

Further study details as provided by Cosmeta:

Primary Outcome Measures:

Safety and effectiveness of CosmetaLife at 6 months
Adverse event reporting

Secondary Outcome Measures:

Safety and effectiveness of CosmetaLife at 3, 9 and 12 months

Estimated Enrollment:	150
Study Start Date:	October 2006
Estimated Study Completion Date:	March 2008

Detailed Description:

Patients with negative allergy test results will be randomized to receive CosmetaLife in one nasolabial fold and Control in the nasolabial fold on the opposite side of the face. Each subject will serve as his or her own control, allowing for comparison of the outcome between the contra-lateral sides. Patients will be followed at 2 weeks and 3, 6, 9 and 12 months post treatment for assessment of safety and effectiveness.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients 18 years of age or older
Patients with moderate to severe nasolabial folds
Patients willing to provide written informed consent for their participation in the study
Patients willing to abstain from other facial cosmetic procedures through the 12 month follow-up visit

Exclusion Criteria:

Patients with any aesthetic facial therapy within 6 months prior to
Patients with an allergic reaction to the skin test
Patients with a history of autoimmune disorder, lidocaine reactions, allergy to heparin, other severe or chronic allergies
Patients with a current disease state that can effect the immunoresponse, or patients on immunosuppressive therapy
Patients with an active infection of any kind, skin disease, connective tissue disorder
Patients who are pregnant or lactating
Patients enrolled in another investigational clinical trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414544

Locations


United States, California
	Beauty Renewed
	Tracy, California, United States, 95376

United States, Georgia
	North Atlantic Plastic and Reconstructive Surgery
	Roswell, Georgia, United States, 30076

United States, Massachusetts
	SkinCare Physicians of Chestnut Hill
	Chestnut Hill, Massachusetts, United States, 02467

United States, Minnesota
	Minnesota Clinical Study Center
	Fridley, Minnesota, United States, 55432
	Cosmetic Care Center, LLC
	Edina, Minnesota, United States, 55424

Sponsors and Collaborators

Cosmeta

Investigators


Study Director:	David B. Masters, Ph.D.	Cosmeta™ Corp

More Information

Study ID Numbers:	CosmetaLife 1
First Received:	December 20, 2006
Last Updated:	February 9, 2007
ClinicalTrials.gov Identifier:	NCT00414544
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cosmeta:

Nasolabial folds

Dermal filler

Injectable dermal filler

Soft tissue augmentation

Study placed in the following topic categories:

Facies

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Cosmeta
Information provided by:	Cosmeta
ClinicalTrials.gov Identifier:	NCT00414544