Facial Wrinkles
Conditions
Keywords
wrinkles, soft tissue filler, Aquamid
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.
Interventions
DEVICEAquamid
Subcutaneous injection
DEVICERestylane
Injection in dermis
Sponsors
Contura
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrinkle Assessment Scale | Baseline, 3, 6, 9, 12 Months |
| Adverse device effects | continuosly |
Secondary
| Measure | Time frame |
|---|---|
| Global Aesthetic Improvement Scale | Optimal treatment, 3, 6, 9 and 12 Months |
| Injection site reactions | After injection |
| Adverse events | continuosly |
Countries
United States
Outcome results
None listed