Lip Augmentation
Conditions
Brief summary
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Kysse.
Interventions
DEVICEHyaluronic acid
Injectable gel for lip augmentation
Sponsors
Galderma R&D
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Signed and dated informed consent to participate in the study * Adult women and men who intend to undergo lip augmentation
Exclusion criteria
* Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics * Subjects with a previous implant other than HA in or near the intended treatment site * Participation in any other clinical study within three (3) months before treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess Treatment With Restylane Kysse Using GAIS | 8 weeks after last treatment | The 5-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the lips compared to pre-treatment. The rating is very much improved, much improved, improved, no change, or worse. Responders are those with a rating of at least improved. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restylane Kysse Hyaluronic acid
Hyaluronic acid: Injectable gel for lip augmentation | 19 |
| Restylane Kysse With Other HA Hyaluronic acid
Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds | 40 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Restylane Kysse | Total | Restylane Kysse With Other HA |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 56 Participants | 38 Participants |
| Age, Continuous | 36.1 years STANDARD_DEVIATION 13.26 | 46.2 years STANDARD_DEVIATION 13.34 | 50.9 years STANDARD_DEVIATION 10.53 |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Race White | 17 Participants | 53 Participants | 36 Participants |
| Region of Enrollment Canada | 19 participants | 59 participants | 40 participants |
| Sex: Female, Male Female | 18 Participants | 56 Participants | 38 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 40 |
| other Total, other adverse events | 10 / 19 | 25 / 40 |
| serious Total, serious adverse events | 0 / 19 | 0 / 40 |
Outcome results
Primary
Assess Treatment With Restylane Kysse Using GAIS
The 5-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the lips compared to pre-treatment. The rating is very much improved, much improved, improved, no change, or worse. Responders are those with a rating of at least improved.
Time frame: 8 weeks after last treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Restylane Kysse | Assess Treatment With Restylane Kysse Using GAIS | 18 Participants |
| Restylane Kysse With Other HA | Assess Treatment With Restylane Kysse Using GAIS | 38 Participants |