Trial Outcomes & Findings for New Dermal Filler for Lip Augmentation (NCT NCT03320824)
NCT ID: NCT03320824
Last Updated: 2022-08-26
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
273 participants
Primary outcome timeframe
8 weeks after last injection
Results posted on
2022-08-26
Participant Flow
Participant milestones
| Measure |
New Dermal Filler
hyaluronic acid
New Dermal Filler: hyaluronic acid
|
Dermal Filler
hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid
|
|---|---|---|
|
Overall Study
STARTED
|
184
|
89
|
|
Overall Study
COMPLETED
|
166
|
85
|
|
Overall Study
NOT COMPLETED
|
18
|
4
|
Reasons for withdrawal
| Measure |
New Dermal Filler
hyaluronic acid
New Dermal Filler: hyaluronic acid
|
Dermal Filler
hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
1
|
|
Overall Study
Lost to Follow-up
|
10
|
1
|
|
Overall Study
moved out of state
|
0
|
1
|
|
Overall Study
could not complete final visit
|
0
|
1
|
Baseline Characteristics
New Dermal Filler for Lip Augmentation
Baseline characteristics by cohort
| Measure |
New Dermal Filler
n=183 Participants
hyaluronic acid
New Dermal Filler: hyaluronic acid
|
Dermal Filler
n=87 Participants
hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
176 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
154 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
173 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
183 participants
n=5 Participants
|
87 participants
n=7 Participants
|
270 participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST I
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST II
|
77 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST III
|
63 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST IV
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST V
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST VI
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after last injectionThe 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).
Outcome measures
| Measure |
New Dermal Filler
n=176 Participants
hyaluronic acid
New Dermal Filler: hyaluronic acid
|
Dermal Filler
n=85 Participants
hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid
|
|---|---|---|
|
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
|
1.7 Change in MLFS score from baseline
Standard Deviation 0.91
|
|
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
|
1.8 Change in MLFS score from baseline
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: 16, 24, 32, 40, and 48 weeks after last injectionPopulation: Observed cases at each visit, New Dermal Filler
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.
Outcome measures
| Measure |
New Dermal Filler
n=183 Participants
hyaluronic acid
New Dermal Filler: hyaluronic acid
|
Dermal Filler
hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 1.00
|
—
|
|
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 outcome
Timeframe: 16, 24, 32, 40, and 48 weeksPopulation: Responder is defined as subjects with at least one point improvement from baseline MLFS (blinded evaluator). Response in both lips concurrently.
Based on Response Rates (defined as at least 1 point improvement from baseline) after treatment with New Dermal Filler
Outcome measures
| Measure |
New Dermal Filler
n=183 Participants
hyaluronic acid
New Dermal Filler: hyaluronic acid
|
Dermal Filler
hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid
|
|---|---|---|
|
Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale
Week 16
|
142 Participants
|
—
|
|
Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale
Week 24
|
129 Participants
|
—
|
|
Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale
Week 32
|
115 Participants
|
—
|
|
Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale
Week 40
|
110 Participants
|
—
|
|
Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale
Week 48
|
101 Participants
|
—
|
SECONDARY outcome
Timeframe: 8, 16, 24, 32, 40, and 48 weeks after last injectionPopulation: Number observed at each visit, New Dermal Filler
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.
Outcome measures
| Measure |
New Dermal Filler
n=183 Participants
hyaluronic acid
New Dermal Filler: hyaluronic acid
|
Dermal Filler
hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 1.00
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 1.30
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: 8, 16, 24, 32, 40, and 48 weeksPopulation: Observed cases at each visit
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. .
Outcome measures
| Measure |
New Dermal Filler
n=183 Participants
hyaluronic acid
New Dermal Filler: hyaluronic acid
|
Dermal Filler
hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: 8, 16, 24, 32, 40, and 48 weeksPopulation: Observed cases at each visit, New Dermal Filler
Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by subject, upper and lower lip combined, New Dermal Filler
Outcome measures
| Measure |
New Dermal Filler
n=183 Participants
hyaluronic acid
New Dermal Filler: hyaluronic acid
|
Dermal Filler
hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: 8, 16, 24, 32, 40, and 48 weeksPopulation: Observed cases at each visit
Determined by Response Rates, Treating Investigator Assessment, New Dermal Filler
Outcome measures
| Measure |
New Dermal Filler
n=183 Participants
hyaluronic acid
New Dermal Filler: hyaluronic acid
|
Dermal Filler
hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: 8, 24, 40, and 48 weeksPopulation: 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
Proportion of Improvement (Responders) Based on Independent Photographic Reviewer Assessment by Weeks after Last Injection, New Dermal Filler
Outcome measures
| Measure |
New Dermal Filler
n=183 Participants
hyaluronic acid
New Dermal Filler: hyaluronic acid
|
Dermal Filler
hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid
|
|---|---|---|
|
Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer
Upper lip, Week 8
|
168 Participants
|
—
|
|
Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer
Lower lip, Week 8
|
164 Participants
|
—
|
|
Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer
Upper lip, Week 24
|
149 Participants
|
—
|
|
Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer
Lower lip, Week 24
|
144 Participants
|
—
|
|
Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer
Upper lip, Week 40
|
149 Participants
|
—
|
|
Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer
Lower lip, Week 40
|
138 Participants
|
—
|
|
Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer
Upper lip, Week 48
|
152 Participants
|
—
|
|
Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer
Lower lip, Week 48
|
147 Participants
|
—
|
SECONDARY outcome
Timeframe: 8, 16, 24, 32, 40, and 48 weeksPopulation: Observed cases at each visit, New Dermal Filler
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.
Outcome measures
| Measure |
New Dermal Filler
n=183 Participants
hyaluronic acid
New Dermal Filler: hyaluronic acid
|
Dermal Filler
hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid
|
|---|---|---|
|
Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q
Baseline
|
28.1 score on a scale
Standard Deviation 16.47
|
—
|
|
Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q
Week 8
|
83.3 score on a scale
Standard Deviation 20.23
|
—
|
|
Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q
Week 16
|
76.2 score on a scale
Standard Deviation 24.06
|
—
|
|
Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q
Week 24
|
74.9 score on a scale
Standard Deviation 24.34
|
—
|
|
Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q
Week 32
|
72.0 score on a scale
Standard Deviation 24.02
|
—
|
|
Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q
Week 40
|
69.0 score on a scale
Standard Deviation 25.48
|
—
|
|
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 outcome
Timeframe: 48 weeksPopulation: 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
Outcome measures
| Measure |
New Dermal Filler
n=185 Participants
hyaluronic acid
New Dermal Filler: hyaluronic acid
|
Dermal Filler
n=88 Participants
hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid
|
|---|---|---|
|
Evaluate All Reported Adverse Events
Treatment Emergent Adverse Event (TEAE)
|
72 Participants
|
31 Participants
|
|
Evaluate All Reported Adverse Events
Serious TEAE
|
2 Participants
|
0 Participants
|
|
Evaluate All Reported Adverse Events
TEAE related to product and/or injection procedure
|
39 Participants
|
22 Participants
|
|
Evaluate All Reported Adverse Events
Serious TEAEs, related
|
0 Participants
|
0 Participants
|
|
Evaluate All Reported Adverse Events
Unrelated TEAE
|
44 Participants
|
22 Participants
|
|
Evaluate All Reported Adverse Events
No TEAEs
|
113 Participants
|
57 Participants
|
Adverse Events
New Dermal Filler
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
Dermal Filler
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
New Dermal Filler
n=185 participants at risk
hyaluronic acid
New Dermal Filler: hyaluronic acid
|
Dermal Filler
n=88 participants at risk
hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.54%
1/185 • Number of events 1 • 1 year
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.
|
0.00%
0/88 • 1 year
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.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.54%
1/185 • Number of events 1 • 1 year
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.
|
0.00%
0/88 • 1 year
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.
|
Other adverse events
| Measure |
New Dermal Filler
n=185 participants at risk
hyaluronic acid
New Dermal Filler: hyaluronic acid
|
Dermal Filler
n=88 participants at risk
hyaluronic acid
Device: FDA Approved Dermal Filler: hyaluronic acid
|
|---|---|---|
|
General disorders
Injection site bruising
|
7.6%
14/185 • Number of events 37 • 1 year
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.
|
10.2%
9/88 • Number of events 71 • 1 year
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.
|
|
General disorders
injection site mass
|
10.3%
19/185 • Number of events 34 • 1 year
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.
|
11.4%
10/88 • Number of events 22 • 1 year
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.
|
|
General disorders
injection site nodule
|
5.4%
10/185 • Number of events 18 • 1 year
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.
|
6.8%
6/88 • Number of events 18 • 1 year
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs agree not to present or publish any data or reports collected individually or by subgroup of sites prior to full, initial publication based on all data obtained from all sites.
- Publication restrictions are in place
Restriction type: OTHER