Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds

Completed · Phase 2

Conditions studied: Facial Wrinkles

In brief

This is a randomized, double-blind pivotal 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).

Key facts

Study ID: NCT00414544
Run by: Cosmeta
People needed: 145
Starts: 2006-10-01
Expected to finish: 2008-03-01
Last updated by the study team: 2011-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Patients 18 years of age or older
Patients with moderate nasolabial folds (3-4 WSRS scale)
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

You may not qualify if…

Patients with any aesthetic facial therapy within 6 months prior to
Patients with an any 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

Where it is running

Beauty Renewed — Tracy, California, United States
North Atlantic Plastic and Reconstructive Surgery — Roswell, Georgia, United States
SkinCare Physicians of Chestnut Hill — Chestnut Hill, Massachusetts, United States
Cosmetic Care Center, LLC — Edina, Minnesota, United States
Minnesota Clinical Study Center — Fridley, Minnesota, United States

Full record on ClinicalTrials.gov

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