NCT02703948CompletedNot Applicable
Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Restylane Silk with Lidocaine
Other
Intervention: Restylane Silk with Lidocaine (Device)
Outcomes
Primary Outcomes
Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
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