Lip Augmentation and Correction of Perioral Rhytids
Conditions
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 .
Interventions
DEVICERestylane Silk with Lidocaine
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine | 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restylane Silk With Lidocaine Restylane Silk with Lidocaine | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Restylane Silk With Lidocaine |
|---|---|
| Age, Continuous | 46.5 years STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 53 Participants |
| Region of Enrollment United States | 60 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 11 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Restylane Silk With Lidocaine | Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine | 11 Participants |