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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Split-face injection of Juvéderm Ultra into vertical lip rhytids and radial cheek lines on one side of face
Split-face injection of Cosmoderm 1 into vertical lip rhytids and radial cheek lines on one side of face
Steven Fagien, MD, PA
Boca Raton, Florida, United States
Global Assessment of Improvement by Physician Evaluator
Global Assessment of Improvement by Physician Evaluator, including Facial Photographs, Vertical Lip Rhytids and Radial Cheek Line Rating Scales
Time frame: 3 days, 2 and 6 weeks, 4 and 6 months
Patient Efficacy, Pain, Adverse Event Assessments
* Facial Line Outcomes (FLO-11 version 1.0) Questionnaire - Patient * Self-Perception of Age (SPA version 2.0) measure - Patient * Global Assessment of Improvement - Patient * Self-Rated Pain Assessment Scale (0-10 point rating scale) * Treatment-emergent adverse events
Time frame: 3 days, 2 and 6 weeks, 4 and 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.