NCT01212809

Comparative Study of Reconstituted JUVÉDERM® Ultra vs COSMODERM® 1 for Lip and Cheek Lines, Folds or Wrinkles

A Prospective, Open Label, Randomized, Comparative, Split-Face Study Evaluating Reconstituted JUVÉDERM® Ultra Injectable Gel Versus COSMODERM® 1 Human Based Collagen Implant for the Treatment of Vertical Lip Rhytids and Radial Cheek Lines

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Steven Fagien · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to evaluate the differences in the performance of two well known injectable dermal fillers commonly used for the cosmetic treatment of age lines above the lips and on the cheeks when compared to each other in the same patient. The products being tested are Juvéderm® Ultra and CosmoDerm® 1.

Detailed description

This is a single center, prospective, open label, randomized, comparative, split-face study in adult females or males aged 25 to 70 years seeking treatment with reconstituted Juvéderm® Ultra and CosmoDerm® 1 human-based collagen implant for moderate to severe vertical lip rhytids and/or radial cheek lines.

Conditions

• Intrinsic Aging of Skin

Interventions

Type	Name	Description
DEVICE	Juvéderm Ultra	Split-face injection of Juvéderm Ultra into vertical lip rhytids and radial cheek lines on one side of face
DEVICE	Cosmoderm 1	Split-face injection of Cosmoderm 1 into vertical lip rhytids and radial cheek lines on one side of face

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-04-01
• Completion: 2011-06-01
• First posted: 2010-10-01
• Last updated: 2011-09-12

Locations

1 site across 1 country: United States