NCT00414544

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Cosmeta · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

Patients with negative reaction skin 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 (split face design). Each subject will serve as his or her own control, allowing for comparison of the outcome between the contralateral sides. Patients will be followed at 2 weeks and 3, 6, 9 and 12 months post treatment for assessment of safety and effectiveness.

Conditions

• Facial Wrinkles

Interventions

Type	Name	Description
DEVICE	CosmetaLife	Dermal filler
DEVICE	Restylane	Dermal filler

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-09-01
• Completion: 2008-03-01
• First posted: 2006-12-21
• Last updated: 2011-06-27
• Results posted: 2011-06-10

Locations

5 sites across 1 country: United States