Lip Augmentation
Conditions
Brief summary
To demonstrate non-inferiority of Kysse versus a control in lip fullness augmentation
Interventions
DEVICENew Dermal Filler
hyaluronic acid
DEVICEDevice: FDA Approved Dermal Filler
hyaluronic acid
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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 a signed written informed consent. * Males or non-pregnant, non-breastfeeding females, 22 years of age or older. * Seeking augmentation therapy for the lips
Exclusion criteria
* Allergy of hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins. * Allergy or hypersensitivity to lidocaine or other amide-type anesthetics, or topical anesthetics or nerve blocking agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS) | 8 weeks after last injection | The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness (grades 0-5, with a higher score reflecting greater lip fullness) was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline at 8 weeks after last injection of New Dermal Filler or Dermal Filler (control). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | 16, 24, 32, 40, and 48 weeks after last injection | The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness (grades 0-5, with a higher score reflecting greater lip fullness) was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline at X weeks after last injection of New Dermal Filler. |
| Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | 8, 16, 24, 32, 40, and 48 weeks after last injection | Based on Change from Baseline, New Dermal Filler using WAS. Scoring of the upper perioral rhytids and oral commissures was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Scoring of fold severity was based on visual assessment of the length and apparent depth of the wrinkle at a certain time-point and measured on a 6-point scale, with 0 being no wrinkle and 5 being very deep wrinkle/redundant fold. |
| Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | 8, 16, 24, 32, 40, and 48 weeks | Based on Response Rates (defined as at least 1 point improvement from baseline), New Dermal Filler using WAS. Scoring of the upper perioral rhytids and oral commissures was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Scoring of fold severity was based on visual assessment of the length and apparent depth of the wrinkle at a certain time-point and measured on a 6-point scale, with 0 being no wrinkle and 5 being very deep wrinkle/redundant fold. . |
| Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator | 8, 16, 24, 32, 40, and 48 weeks | Determined by Response Rates, Treating Investigator Assessment, New Dermal Filler |
| Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer | 8, 24, 40, and 48 weeks | Proportion of Improvement (Responders) Based on Independent Photographic Reviewer Assessment by Weeks after Last Injection, New Dermal Filler |
| Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q | 8, 16, 24, 32, 40, and 48 weeks | Subjects' satisfaction using the validated FACE-Q scales Satisfaction with Lips and Appraisal of Lines: Lips at baseline and at Week 8, 16, 24, 32, 40, and 48 weeks after last injection based on individual questions in each questionnaire as well as the Rasch transformed total scores and the change from baseline in the Rasch transformed scores. Rasch-transformed total score (0-100) according the FACE-Q manual; the higher total score indicated greater subject satisfaction.A positive change from baseline indicates an improvement. Baseline is defined as the last observation before initial treatment takes place at the baseline visit on Day 1. |
| Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment | 8, 16, 24, 32, 40, and 48 weeks | Responders defined as at least improved (improved, much improved, very much improved) as assessed by subject, upper and lower lip combined, New Dermal Filler |
Other
| Measure | Time frame |
|---|---|
| Evaluate All Reported Adverse Events | 48 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| New Dermal Filler hyaluronic acid
New Dermal Filler: hyaluronic acid | 183 |
| Dermal Filler hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid | 87 |
| Total | 270 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | could not complete final visit | 0 | 1 |
| Overall Study | Lost to Follow-up | 10 | 1 |
| Overall Study | moved out of state | 0 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 1 |
Baseline characteristics
| Characteristic | Dermal Filler | Total | New Dermal Filler |
|---|---|---|---|
| Age, Continuous | 53.6 years STANDARD_DEVIATION 10.8 | 52.8 years STANDARD_DEVIATION 12.7 | 52.4 years STANDARD_DEVIATION 13.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 44 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants | 226 Participants | 154 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type (FST) FST I | 4 Participants | 11 Participants | 7 Participants |
| Fitzpatrick Skin Type (FST) FST II | 31 Participants | 108 Participants | 77 Participants |
| Fitzpatrick Skin Type (FST) FST III | 34 Participants | 97 Participants | 63 Participants |
| Fitzpatrick Skin Type (FST) FST IV | 13 Participants | 36 Participants | 23 Participants |
| Fitzpatrick Skin Type (FST) FST V | 4 Participants | 14 Participants | 10 Participants |
| Fitzpatrick Skin Type (FST) FST VI | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 81 Participants | 254 Participants | 173 Participants |
| Region of Enrollment United States | 87 participants | 270 participants | 183 participants |
| Sex: Female, Male Female | 85 Participants | 261 Participants | 176 Participants |
| Sex: Female, Male Male | 2 Participants | 9 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 185 | 0 / 88 |
| other Total, other adverse events | 43 / 185 | 25 / 88 |
| serious Total, serious adverse events | 2 / 185 | 0 / 88 |
Outcome results
Primary
Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS)
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness (grades 0-5, with a higher score reflecting greater lip fullness) was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline at 8 weeks after last injection of New Dermal Filler or Dermal Filler (control).
Time frame: 8 weeks after last injection
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Dermal Filler | Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS) | Upper lip | 1.8 Change in MLFS score from baseline | Standard Deviation 0.96 |
| New Dermal Filler | Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS) | Lower lip | 1.8 Change in MLFS score from baseline | Standard Deviation 0.98 |
| Dermal Filler | Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS) | Upper lip | 1.7 Change in MLFS score from baseline | Standard Deviation 0.91 |
| Dermal Filler | Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS) | Lower lip | 1.8 Change in MLFS score from baseline | Standard Deviation 0.86 |
Secondary
Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator)
Based on Change from Baseline, New Dermal Filler using WAS. Scoring of the upper perioral rhytids and oral commissures was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Scoring of fold severity was based on visual assessment of the length and apparent depth of the wrinkle at a certain time-point and measured on a 6-point scale, with 0 being no wrinkle and 5 being very deep wrinkle/redundant fold.
Time frame: 8, 16, 24, 32, 40, and 48 weeks after last injection
Population: Number observed at each visit, New Dermal Filler
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Upper Perioral Lines, Week 8 | -2.2 change in WAS score from baseline | Standard Deviation 0.99 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Upper Perioral Lines, Week 16 | -1.8 change in WAS score from baseline | Standard Deviation 0.97 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Upper Perioral Lines, Week 24 | -1.7 change in WAS score from baseline | Standard Deviation 0.95 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Upper Perioral Lines, Week 32 | -1.6 change in WAS score from baseline | Standard Deviation 1 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Upper Perioral Lines, Week 40 | -1.5 change in WAS score from baseline | Standard Deviation 0.87 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Upper Perioral Lines, Week 48 | -1.6 change in WAS score from baseline | Standard Deviation 1.04 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Left oral commissure Week 8 | -1.5 change in WAS score from baseline | Standard Deviation 1.11 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Right oral commissure Week 8 | -1.4 change in WAS score from baseline | Standard Deviation 1.05 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Left oral commissure Week 16 | -1.4 change in WAS score from baseline | Standard Deviation 1.19 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Right oral commissure Week 16 | -1.3 change in WAS score from baseline | Standard Deviation 1.08 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Left oral commissure Week 24 | -1.3 change in WAS score from baseline | Standard Deviation 1.05 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Right oral commissure Week 24 | -1.2 change in WAS score from baseline | Standard Deviation 1.11 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Left oral commissure Week 32 | -1.3 change in WAS score from baseline | Standard Deviation 1.24 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Right oral commissure Week 32 | -1.2 change in WAS score from baseline | Standard Deviation 1.14 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Left oral commissure Week 40 | -1.1 change in WAS score from baseline | Standard Deviation 1.3 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Right oral commissure Week 40 | -1.1 change in WAS score from baseline | Standard Deviation 1.21 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Left oral commissure Week 48 | -1.2 change in WAS score from baseline | Standard Deviation 1.28 |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) | Right oral commissure Week 48 | -1.1 change in WAS score from baseline | Standard Deviation 1.25 |
Secondary
Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator)
Based on Response Rates (defined as at least 1 point improvement from baseline), New Dermal Filler using WAS. Scoring of the upper perioral rhytids and oral commissures was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Scoring of fold severity was based on visual assessment of the length and apparent depth of the wrinkle at a certain time-point and measured on a 6-point scale, with 0 being no wrinkle and 5 being very deep wrinkle/redundant fold. .
Time frame: 8, 16, 24, 32, 40, and 48 weeks
Population: Observed cases at each visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Upper Perioral Lines, Week 8 | 50 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Upper Perioral Lines, Week 16 | 47 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Upper Perioral Lines, Week 24 | 47 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Upper Perioral Lines, Week 32 | 47 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Upper Perioral Lines, Week 40 | 47 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Upper Perioral Lines, Week 48 | 44 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Left oral commissure Week 8 | 106 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Left oral commissure Week 16 | 102 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Left oral commissure Week 24 | 98 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Left oral commissure Week 32 | 94 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Left oral commissure Week 40 | 87 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Left oral commissure Week 48 | 90 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Right oral commissure Week 8 | 104 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Right oral commissure Week 16 | 101 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Right oral commissure Week 24 | 97 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Right oral commissure Week 32 | 89 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Right oral commissure Week 40 | 86 Participants |
| New Dermal Filler | Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) | Right oral commissure Week 48 | 83 Participants |
Secondary
Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness (grades 0-5, with a higher score reflecting greater lip fullness) was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline at X weeks after last injection of New Dermal Filler.
Time frame: 16, 24, 32, 40, and 48 weeks after last injection
Population: Observed cases at each visit, New Dermal Filler
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Dermal Filler | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Upper lip Week 16 | 1.6 score on a scale | Standard Deviation 0.92 |
| New Dermal Filler | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Lower lip Week 16 | 1.6 score on a scale | Standard Deviation 0.96 |
| New Dermal Filler | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Upper lip Week 24 | 1.4 score on a scale | Standard Deviation 0.94 |
| New Dermal Filler | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Lower lip Week 24 | 1.4 score on a scale | Standard Deviation 0.98 |
| New Dermal Filler | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Upper lip Week 32 | 1.2 score on a scale | Standard Deviation 0.91 |
| New Dermal Filler | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Lower lip Week 32 | 1.3 score on a scale | Standard Deviation 0.94 |
| New Dermal Filler | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Upper lip Week 40 | 1.2 score on a scale | Standard Deviation 0.98 |
| New Dermal Filler | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Lower lip Week 40 | 1.3 score on a scale | Standard Deviation 1 |
| New Dermal Filler | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Upper lip Week 48 | 1.0 score on a scale | Standard Deviation 0.91 |
| New Dermal Filler | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Lower lip Week 48 | 1.1 score on a scale | Standard Deviation 0.94 |
Secondary
Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale
Based on Response Rates (defined as at least 1 point improvement from baseline) after treatment with New Dermal Filler
Time frame: 16, 24, 32, 40, and 48 weeks
Population: Responder is defined as subjects with at least one point improvement from baseline MLFS (blinded evaluator). Response in both lips concurrently.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Dermal Filler | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Week 16 | 142 Participants |
| New Dermal Filler | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Week 24 | 129 Participants |
| New Dermal Filler | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Week 32 | 115 Participants |
| New Dermal Filler | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Week 40 | 110 Participants |
| New Dermal Filler | Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale | Week 48 | 101 Participants |
Secondary
Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer
Proportion of Improvement (Responders) Based on Independent Photographic Reviewer Assessment by Weeks after Last Injection, New Dermal Filler
Time frame: 8, 24, 40, and 48 weeks
Population: Observed cases at each visit. Response is defined as an improvement from baseline assessed via random, blinded pairing and review of the baseline and post-baseline photographs
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Dermal Filler | Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer | Upper lip, Week 48 | 152 Participants |
| New Dermal Filler | Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer | Upper lip, Week 8 | 168 Participants |
| New Dermal Filler | Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer | Lower lip, Week 8 | 164 Participants |
| New Dermal Filler | Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer | Upper lip, Week 24 | 149 Participants |
| New Dermal Filler | Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer | Lower lip, Week 24 | 144 Participants |
| New Dermal Filler | Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer | Upper lip, Week 40 | 149 Participants |
| New Dermal Filler | Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer | Lower lip, Week 40 | 138 Participants |
| New Dermal Filler | Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer | Lower lip, Week 48 | 147 Participants |
Secondary
Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment
Responders defined as at least improved (improved, much improved, very much improved) as assessed by subject, upper and lower lip combined, New Dermal Filler
Time frame: 8, 16, 24, 32, 40, and 48 weeks
Population: Observed cases at each visit, New Dermal Filler
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Dermal Filler | Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment | Week 8 | 170 Participants |
| New Dermal Filler | Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment | Week 16 | 161 Participants |
| New Dermal Filler | Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment | Week 24 | 148 Participants |
| New Dermal Filler | Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment | Week 32 | 140 Participants |
| New Dermal Filler | Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment | Week 40 | 131 Participants |
| New Dermal Filler | Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment | Week 48 | 132 Participants |
Secondary
Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator
Determined by Response Rates, Treating Investigator Assessment, New Dermal Filler
Time frame: 8, 16, 24, 32, 40, and 48 weeks
Population: Observed cases at each visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Dermal Filler | Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator | Upper and lower lip combined, Week 8 | 175 Participants |
| New Dermal Filler | Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator | Upper and lower lip combined, Week 16 | 169 Participants |
| New Dermal Filler | Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator | Upper and lower lip combined, Week 24 | 145 Participants |
| New Dermal Filler | Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator | Upper and lower lip combined, Week 32 | 137 Participants |
| New Dermal Filler | Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator | Upper and lower lip combined, Week 40 | 121 Participants |
| New Dermal Filler | Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator | Upper and lower lip combined, Week 48 | 114 Participants |
Secondary
Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q
Subjects' satisfaction using the validated FACE-Q scales Satisfaction with Lips and Appraisal of Lines: Lips at baseline and at Week 8, 16, 24, 32, 40, and 48 weeks after last injection based on individual questions in each questionnaire as well as the Rasch transformed total scores and the change from baseline in the Rasch transformed scores. Rasch-transformed total score (0-100) according the FACE-Q manual; the higher total score indicated greater subject satisfaction.A positive change from baseline indicates an improvement. Baseline is defined as the last observation before initial treatment takes place at the baseline visit on Day 1.
Time frame: 8, 16, 24, 32, 40, and 48 weeks
Population: Observed cases at each visit, New Dermal Filler
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New Dermal Filler | Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q | Baseline | 28.1 score on a scale | Standard Deviation 16.47 |
| New Dermal Filler | Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q | Week 8 | 83.3 score on a scale | Standard Deviation 20.23 |
| New Dermal Filler | Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q | Week 16 | 76.2 score on a scale | Standard Deviation 24.06 |
| New Dermal Filler | Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q | Week 24 | 74.9 score on a scale | Standard Deviation 24.34 |
| New Dermal Filler | Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q | Week 32 | 72.0 score on a scale | Standard Deviation 24.02 |
| New Dermal Filler | Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q | Week 40 | 69.0 score on a scale | Standard Deviation 25.48 |
| New Dermal Filler | Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q | Week 48 | 66.3 score on a scale | Standard Deviation 26.68 |
Other Pre-specified
Evaluate All Reported Adverse Events
Time frame: 48 weeks
Population: Safety population, Initial and Touch-up Treatment. One subject randomized to the dermal filler group received the new dermal filler in error. This subject is included in the new dermal filler group for safety analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Dermal Filler | Evaluate All Reported Adverse Events | Treatment Emergent Adverse Event (TEAE) | 72 Participants |
| New Dermal Filler | Evaluate All Reported Adverse Events | Serious TEAE | 2 Participants |
| New Dermal Filler | Evaluate All Reported Adverse Events | TEAE related to product and/or injection procedure | 39 Participants |
| New Dermal Filler | Evaluate All Reported Adverse Events | Serious TEAEs, related | 0 Participants |
| New Dermal Filler | Evaluate All Reported Adverse Events | Unrelated TEAE | 44 Participants |
| New Dermal Filler | Evaluate All Reported Adverse Events | No TEAEs | 113 Participants |
| Dermal Filler | Evaluate All Reported Adverse Events | Unrelated TEAE | 22 Participants |
| Dermal Filler | Evaluate All Reported Adverse Events | Treatment Emergent Adverse Event (TEAE) | 31 Participants |
| Dermal Filler | Evaluate All Reported Adverse Events | Serious TEAEs, related | 0 Participants |
| Dermal Filler | Evaluate All Reported Adverse Events | Serious TEAE | 0 Participants |
| Dermal Filler | Evaluate All Reported Adverse Events | No TEAEs | 57 Participants |
| Dermal Filler | Evaluate All Reported Adverse Events | TEAE related to product and/or injection procedure | 22 Participants |