Trial Outcomes & Findings for A Study of Belotero® Intense Lidocaine for Lip Augmentation (NCT NCT05773066)
NCT ID: NCT05773066
Last Updated: 2026-08-18
Results Overview
Responder rate was defined as percentage of subjects with greater than or equal to (\>=) 1-point improvement on subject's treated lips compared to baseline as assessed live by a blinded evaluator. MLFAS was a validated 5-grade scale used to assess the volume of the upper and lower lips, where Grade 0=very thin lips with minimal volume and Grade 4=very full lips with significant volume. A positive number change from baseline indicated improvement.
COMPLETED
NA
220 participants
At Week 8
2026-08-18
Participant Flow
Subjects were recruited from 14 investigational sites in the United States.
Of the 250 screened, 30 were exited as screen failures. 165 subjects were randomized to Belotero® Intense Lidocaine (BIL) group, and 55 subjects were randomized to Restylane® Silk (RS) group.
Participant milestones
| Measure |
Belotero® Intense Lidocaine (BIL)
Subjects were randomized to receive BIL (Dermal hyaluronic acid \[HA\] filler for lip augmentation) single injection in the submucosal or subcutaneous plane of lips at Day 1 as an initial treatment, on Week 4 and then on Week 48 as an optional injection.
|
Restylane® Silk (RS)
Subjects were randomized to receive RS (HA gel for lip augmentation) injection in a submucosal plane of lips as an initial injection on Day 1 and Week 4.
|
|---|---|---|
|
Overall Study
STARTED
|
165
|
55
|
|
Overall Study
COMPLETED
|
149
|
46
|
|
Overall Study
NOT COMPLETED
|
16
|
9
|
Reasons for withdrawal
| Measure |
Belotero® Intense Lidocaine (BIL)
Subjects were randomized to receive BIL (Dermal hyaluronic acid \[HA\] filler for lip augmentation) single injection in the submucosal or subcutaneous plane of lips at Day 1 as an initial treatment, on Week 4 and then on Week 48 as an optional injection.
|
Restylane® Silk (RS)
Subjects were randomized to receive RS (HA gel for lip augmentation) injection in a submucosal plane of lips as an initial injection on Day 1 and Week 4.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
9
|
3
|
Baseline Characteristics
A Study of Belotero® Intense Lidocaine for Lip Augmentation
Baseline characteristics by cohort
| Measure |
Belotero® Intense Lidocaine (BIL)
n=165 Participants
Subjects were randomized to receive BIL (Dermal hyaluronic acid \[HA\] filler for lip augmentation) single injection in the submucosal or subcutaneous plane of lips at Day 1 as an initial treatment, on Week 4 and then on Week 48 as an optional injection.
|
Restylane® Silk (RS)
n=55 Participants
Subjects were randomized to receive RS (HA gel for lip augmentation) injection in a submucosal plane of lips as an initial injection on Day 1 and Week 4.
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 12.26 • n=298 Participants
|
47.3 years
STANDARD_DEVIATION 10.26 • n=102 Participants
|
46.7 years
STANDARD_DEVIATION 11.77 • n=400 Participants
|
|
Sex: Female, Male
Female
|
161 Participants
n=298 Participants
|
51 Participants
n=102 Participants
|
212 Participants
n=400 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=298 Participants
|
4 Participants
n=102 Participants
|
8 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=298 Participants
|
14 Participants
n=102 Participants
|
47 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
132 Participants
n=298 Participants
|
41 Participants
n=102 Participants
|
173 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
2 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=298 Participants
|
2 Participants
n=102 Participants
|
8 Participants
n=400 Participants
|
|
Race (NIH/OMB)
White
|
153 Participants
n=298 Participants
|
50 Participants
n=102 Participants
|
203 Participants
n=400 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=298 Participants
|
2 Participants
n=102 Participants
|
7 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
PRIMARY outcome
Timeframe: At Week 8Population: The Per protocol set (PPS) included all subjects in the intent to treat (ITT) without important deviations in statistical sense or other reasons for exclusion.
Responder rate was defined as percentage of subjects with greater than or equal to (\>=) 1-point improvement on subject's treated lips compared to baseline as assessed live by a blinded evaluator. MLFAS was a validated 5-grade scale used to assess the volume of the upper and lower lips, where Grade 0=very thin lips with minimal volume and Grade 4=very full lips with significant volume. A positive number change from baseline indicated improvement.
Outcome measures
| Measure |
Belotero® Intense Lidocaine (BIL)
n=158 Participants
Subject were randomized to receive BIL (Dermal hyaluronic acid \[HA\] filler for lip augmentation) single injection in the submucosal or subcutaneous plane of lips at Day 1 as an initial treatment, on Week 4 and then on Week 48 as an optional injection.
|
Restylane® Silk (RS)
n=52 Participants
Subjects were randomized to receive RS (HA gel for lip augmentation) injection in a submucosal plane of lips as an initial injection on Day 1 and Week 4.
|
|---|---|---|
|
Responder Rate at Week 8, According to the MLFAS
|
91.1 percentage of subjects
Interval 85.6 to 95.1
|
90.4 percentage of subjects
Interval 79.0 to 96.8
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: The PPS included all the subjects in the ITT without important deviations in statistical sense or other reasons for exclusion.
MLFAS was a validated 5-grade scale used to assess the volume of the upper and lower lips, where Grade 0=very thin lips with minimal volume and Grade 4=very full lips with significant volume, as assessed live by a blinded evaluator. A positive number change from baseline indicated improvement.
Outcome measures
| Measure |
Belotero® Intense Lidocaine (BIL)
n=158 Participants
Subject were randomized to receive BIL (Dermal hyaluronic acid \[HA\] filler for lip augmentation) single injection in the submucosal or subcutaneous plane of lips at Day 1 as an initial treatment, on Week 4 and then on Week 48 as an optional injection.
|
Restylane® Silk (RS)
n=52 Participants
Subjects were randomized to receive RS (HA gel for lip augmentation) injection in a submucosal plane of lips as an initial injection on Day 1 and Week 4.
|
|---|---|---|
|
Mean Change of Treated Lips From Baseline to Week 8, According to the Merz Lip Fullness Assessment Scale (MLFAS)
|
1.31 score on a scale
Standard Deviation 0.513
|
1.23 score on a scale
Standard Deviation 0.519
|
SECONDARY outcome
Timeframe: At Week 8Population: The PPS included all subjects in the ITT without important deviations in statistical sense or other reasons for exclusion.
The treating investigator assessed the subject's treated lips compared to pre-treatment photos using the 7-point GAIS ranging as +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the investigator, where the higher the iGAIS score, the greater the improvement.
Outcome measures
| Measure |
Belotero® Intense Lidocaine (BIL)
n=158 Participants
Subject were randomized to receive BIL (Dermal hyaluronic acid \[HA\] filler for lip augmentation) single injection in the submucosal or subcutaneous plane of lips at Day 1 as an initial treatment, on Week 4 and then on Week 48 as an optional injection.
|
Restylane® Silk (RS)
n=52 Participants
Subjects were randomized to receive RS (HA gel for lip augmentation) injection in a submucosal plane of lips as an initial injection on Day 1 and Week 4.
|
|---|---|---|
|
Percentage of Subjects With Investigator's Global Aesthetic Improvement Scale (iGAIS) Scores
Improved (+1)
|
7.6 percentage of subjects
|
13.5 percentage of subjects
|
|
Percentage of Subjects With Investigator's Global Aesthetic Improvement Scale (iGAIS) Scores
No Change (0)
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Investigator's Global Aesthetic Improvement Scale (iGAIS) Scores
Worse (-1)
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Investigator's Global Aesthetic Improvement Scale (iGAIS) Scores
Much Worse (-2)
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Investigator's Global Aesthetic Improvement Scale (iGAIS) Scores
Very Much Worse (-3)
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Investigator's Global Aesthetic Improvement Scale (iGAIS) Scores
Very much improved (+3)
|
50.6 percentage of subjects
|
53.8 percentage of subjects
|
|
Percentage of Subjects With Investigator's Global Aesthetic Improvement Scale (iGAIS) Scores
Much improved (+2)
|
41.8 percentage of subjects
|
32.7 percentage of subjects
|
SECONDARY outcome
Timeframe: At Week 8Population: The PPS included all subjects in the ITT without important deviations in statistical sense or other reasons for exclusion.
Subjects assessed their treated lips compared to pre-treatment photos using the 7-point GAIS ranging as +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the investigator, where the higher the iGAIS score, the greater the improvement.
Outcome measures
| Measure |
Belotero® Intense Lidocaine (BIL)
n=158 Participants
Subject were randomized to receive BIL (Dermal hyaluronic acid \[HA\] filler for lip augmentation) single injection in the submucosal or subcutaneous plane of lips at Day 1 as an initial treatment, on Week 4 and then on Week 48 as an optional injection.
|
Restylane® Silk (RS)
n=52 Participants
Subjects were randomized to receive RS (HA gel for lip augmentation) injection in a submucosal plane of lips as an initial injection on Day 1 and Week 4.
|
|---|---|---|
|
Percentage of Subjects With Subject's GAIS Scores (sGAIS)
Very much improved (+3)
|
53.8 percentage of subjects
|
53.8 percentage of subjects
|
|
Percentage of Subjects With Subject's GAIS Scores (sGAIS)
Much improved (+2)
|
37.3 percentage of subjects
|
28.8 percentage of subjects
|
|
Percentage of Subjects With Subject's GAIS Scores (sGAIS)
Improved (+1)
|
8.9 percentage of subjects
|
17.3 percentage of subjects
|
|
Percentage of Subjects With Subject's GAIS Scores (sGAIS)
No change (0)
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Subject's GAIS Scores (sGAIS)
Worse (-1)
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Subject's GAIS Scores (sGAIS)
Much worse (-2)
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Subject's GAIS Scores (sGAIS)
Very much worse (-3)
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: The PPS included subjects in the ITT without important deviations in statistical sense or other reasons for exclusion.
FACE-Q was a set of validated, standardized patient-reported outcome scales for subjects received facial cosmetic procedures. The subject rated the level of satisfaction with their lips by answering 7 questions of the FACE-Q satisfaction using a 4- point scale where 1=Very Dissatisfied and 4=Very Satisfied. The sum FACE-Q scores were Rasch-transformed and ranged from 0 to 100. Higher scores reflected a better outcome (greater satisfaction).
Outcome measures
| Measure |
Belotero® Intense Lidocaine (BIL)
n=158 Participants
Subject were randomized to receive BIL (Dermal hyaluronic acid \[HA\] filler for lip augmentation) single injection in the submucosal or subcutaneous plane of lips at Day 1 as an initial treatment, on Week 4 and then on Week 48 as an optional injection.
|
Restylane® Silk (RS)
n=52 Participants
Subjects were randomized to receive RS (HA gel for lip augmentation) injection in a submucosal plane of lips as an initial injection on Day 1 and Week 4.
|
|---|---|---|
|
Change From Baseline in Rasch-transformed Score of the FACE-Q Satisfaction With Lips
|
50.7 score on a scale
Standard Deviation 22.00
|
51.7 score on a scale
Standard Deviation 23.18
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: The SES is the subset of all subjects who were exposed to the IMD or comparator device at least once.
TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of BIL. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Delayed-onset TEAEs were those with onset \> 21 days after last treatment.
Outcome measures
| Measure |
Belotero® Intense Lidocaine (BIL)
n=165 Participants
Subject were randomized to receive BIL (Dermal hyaluronic acid \[HA\] filler for lip augmentation) single injection in the submucosal or subcutaneous plane of lips at Day 1 as an initial treatment, on Week 4 and then on Week 48 as an optional injection.
|
Restylane® Silk (RS)
n=55 Participants
Subjects were randomized to receive RS (HA gel for lip augmentation) injection in a submucosal plane of lips as an initial injection on Day 1 and Week 4.
|
|---|---|---|
|
Number of Subjects With Related Serious or Related Delayed-onset Treatment Emergent Adverse Events (TEAEs)
Related Serious TEAEs
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Related Serious or Related Delayed-onset Treatment Emergent Adverse Events (TEAEs)
Related Delayed-onset TEAEs
|
4 Participants
|
3 Participants
|
Adverse Events
Belotero® Intense Lidocaine (BIL)
Restylane® Silk (RS)
Serious adverse events
| Measure |
Belotero® Intense Lidocaine (BIL)
n=165 participants at risk
Subjects were randomized to receive BIL (Dermal hyaluronic acid \[HA\] filler for lip augmentation) single injection in the submucosal or subcutaneous plane of lips at Day 1 as an initial treatment, on Week 4 and then on Week 48 as an optional injection.
|
Restylane® Silk (RS)
n=55 participants at risk
Subjects were randomized to receive RS (HA gel for lip augmentation) injection in a submucosal plane of lips as an initial injection on Day 1 and Week 4.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.61%
1/165 • BIL Treatment: Up to 60 weeks; RS Treatment: Up to 48 weeks
SES. The investigator reported AEs systematically at each visit.
|
0.00%
0/55 • BIL Treatment: Up to 60 weeks; RS Treatment: Up to 48 weeks
SES. The investigator reported AEs systematically at each visit.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.61%
1/165 • BIL Treatment: Up to 60 weeks; RS Treatment: Up to 48 weeks
SES. The investigator reported AEs systematically at each visit.
|
0.00%
0/55 • BIL Treatment: Up to 60 weeks; RS Treatment: Up to 48 weeks
SES. The investigator reported AEs systematically at each visit.
|
Other adverse events
| Measure |
Belotero® Intense Lidocaine (BIL)
n=165 participants at risk
Subjects were randomized to receive BIL (Dermal hyaluronic acid \[HA\] filler for lip augmentation) single injection in the submucosal or subcutaneous plane of lips at Day 1 as an initial treatment, on Week 4 and then on Week 48 as an optional injection.
|
Restylane® Silk (RS)
n=55 participants at risk
Subjects were randomized to receive RS (HA gel for lip augmentation) injection in a submucosal plane of lips as an initial injection on Day 1 and Week 4.
|
|---|---|---|
|
General disorders
Injection site mass
|
16.4%
27/165 • BIL Treatment: Up to 60 weeks; RS Treatment: Up to 48 weeks
SES. The investigator reported AEs systematically at each visit.
|
10.9%
6/55 • BIL Treatment: Up to 60 weeks; RS Treatment: Up to 48 weeks
SES. The investigator reported AEs systematically at each visit.
|
|
General disorders
Injection site induration
|
7.3%
12/165 • BIL Treatment: Up to 60 weeks; RS Treatment: Up to 48 weeks
SES. The investigator reported AEs systematically at each visit.
|
7.3%
4/55 • BIL Treatment: Up to 60 weeks; RS Treatment: Up to 48 weeks
SES. The investigator reported AEs systematically at each visit.
|
|
Infections and infestations
COVID-19
|
4.2%
7/165 • BIL Treatment: Up to 60 weeks; RS Treatment: Up to 48 weeks
SES. The investigator reported AEs systematically at each visit.
|
5.5%
3/55 • BIL Treatment: Up to 60 weeks; RS Treatment: Up to 48 weeks
SES. The investigator reported AEs systematically at each visit.
|
|
Investigations
Visual acuity tests abnormal
|
3.6%
6/165 • BIL Treatment: Up to 60 weeks; RS Treatment: Up to 48 weeks
SES. The investigator reported AEs systematically at each visit.
|
5.5%
3/55 • BIL Treatment: Up to 60 weeks; RS Treatment: Up to 48 weeks
SES. The investigator reported AEs systematically at each visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
- Publication restrictions are in place
Restriction type: OTHER