Safety and Effectiveness of Aquamid as Compared to Restylane for the Aesthetic Treatment of Nasolabial Folds
Not Applicable
Completed
- Conditions
- Facial Wrinkles
- Registration Number
- NCT00407914
- Lead Sponsor
- Contura
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 315
Inclusion Criteria
- interested on soft tissue augmentation for the nasolabial folds
- moderate to severe nasolabial fold
Exclusion Criteria
- sensitivity to anesthetics
- allergy to hyaluronic acid
- previous treatment with permanent fillers in the treated area
- recent previous aesthetic procedure in the treatment area
- infected skin areas or autoimmune diseases affecting the skin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Wrinkle Assessment Scale Baseline, 3, 6, 9, 12 Months Adverse device effects continuosly
- Secondary Outcome Measures
Name Time Method Global Aesthetic Improvement Scale Optimal treatment, 3, 6, 9 and 12 Months Injection site reactions After injection Adverse events continuosly