Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation
Not Applicable
Completed
- Conditions
- Lip Augmentation and Correction of Perioral Rhytids
- Registration Number
- NCT02703948
- Lead Sponsor
- Galderma R&D
- Brief Summary
This is a multi-center, open-label, single-arm study to assess the safety of an injection technique with Restylane Silk in lip augmentation and correction of perioral rhytids .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Subjects willing to comply with the requirements of the study and providing written informed consent including release of copyright of photography images.
- Males or females, 22 years of age or older
- Subjects seeking augmentation therapy for the lips.
Exclusion Criteria
- History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins.
- History of allergy or hypersensitivity to lidocaine, other amide type anesthetics, or topical anesthetics or nerve blocking agents
- Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
United States, California
🇺🇸San Diego, California, United States
United States, Florida
🇺🇸Miami, Florida, United States
United States, Georgia
🇺🇸Roswell, Georgia, United States
United States, California🇺🇸San Diego, California, United States