Safety and Effectiveness of Aquamid as Compared to Restylane for the Aesthetic Treatment of Nasolabial Folds
NCT00407914 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 315
Last updated 2009-10-08
Summary
The purpose of this study is to compare the effectiveness of Aquamid and Restylane in aesthetically enhancing nasolabial folds 6 months after treatment and to evaluate the safety of Aquamid through 12 months after treatment.
The study includes an extended follow up to 24 months.
Conditions
- Facial Wrinkles
Interventions
- DEVICE
-
Aquamid
Subcutaneous injection
- DEVICE
-
Restylane
Injection in dermis
Sponsors & Collaborators
-
Contura
lead INDUSTRY
Principal Investigators
-
Silvia Codony · Contura
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2006-12-31
- Primary Completion
- 2008-08-31
- Completion
- 2009-07-31
Countries
- United States
Study Locations
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