An interventional study of Belotero® Intense Lidocaine and Restylane® Silk in Lip Augmentation, sponsored by Merz North America, Inc.. Completed at 14 sites in 2 countries. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Merz North America, Inc. (part of Merz Pharma) · Not applicable, Interventional, and Treatment
The purpose of this study is to demonstrate the safety and effectiveness of Belotero Intense Lidocaine (BIL) for lip augmentation in subjects with upper and/or lower lip deficit.
For all subjects, standardized photographs of the lips will be taken at the screening visit (prior to treatment) and at multiple intervals throughout the study to be used for comparisons and study assessments.
Subjects will receive an injection of either BIL or Restylane Silk (RS) in the upper and/or lower lips. A touch-up injection will be given 4 weeks after the initial treatment if the subject fails to show improvement in 1 or both lips or if the subject does not achieve optimal aesthetic correction. Subjects treated with BIL have the option of a retreatment with BIL 48 weeks post last injection.
Merz North America, Inc. is the lead sponsor of 53 studies on the registry; 2 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 19 (95%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lips injected with BIL.
Device: Belotero® Intense Lidocaine
Lips injected with RS.
Device: Restylane® Silk
Dermal hyaluronic acid (HA) filler for lip augmentation.
HA gel for lip augmentation.
Responder Rate at Week 8, According to the MLFAS
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.
Time frame: At Week 8
Mean Change of Treated Lips From Baseline to Week 8, According to the Merz Lip Fullness Assessment Scale (MLFAS)
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.
Time frame: Baseline, Week 8
Percentage of Subjects With Investigator's Global Aesthetic Improvement Scale (iGAIS) Scores
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.
Time frame: At Week 8
Percentage of Subjects With Subject's GAIS Scores (sGAIS)
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.
Time frame: At Week 8
Change From Baseline in Rasch-transformed Score of the FACE-Q Satisfaction With Lips
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).
Time frame: Baseline, Week 8
Number of Subjects With Related Serious or Related Delayed-onset Treatment Emergent Adverse Events (TEAEs)
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.
Time frame: Up to 48 weeks
Subjects were recruited from 14 investigational sites in the United States.
| Milestone | Belotero® Intense Lidocaine (BIL) | Restylane® Silk (RS) |
|---|---|---|
| Started | 165 | 55 |
| Completed | 149 | 46 |
| Not completed | 16 | 9 |
| Withdrew: Withdrawal by subject | 6 | 6 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Lost to follow-up | 9 | 3 |
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.
| percentage of subjects | Belotero® Intense Lidocaine (BIL) | Restylane® Silk (RS) |
|---|---|---|
| Responder Rate at Week 8, According to the MLFAS | 91.1 (85.6 to 95.1) | 90.4 (79.0 to 96.8) |
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.
| score on a scale | Belotero® Intense Lidocaine (BIL) | Restylane® Silk (RS) |
|---|---|---|
| Mean Change of Treated Lips From Baseline to Week 8, According to the Merz Lip Fullness Assessment Scale (MLFAS) | 1.31 ± 0.513 | 1.23 ± 0.519 |
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.
| percentage of subjects | Belotero® Intense Lidocaine (BIL) | Restylane® Silk (RS) |
|---|---|---|
| Very much improved (+3) | 50.6 | 53.8 |
| Much improved (+2) | 41.8 | 32.7 |
| Improved (+1) | 7.6 | 13.5 |
| No Change (0) | 0.0 | 0.0 |
| Worse (-1) | 0.0 | 0.0 |
| Much Worse (-2) | 0.0 | 0.0 |
| Very Much Worse (-3) | 0.0 | 0.0 |
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.
| percentage of subjects | Belotero® Intense Lidocaine (BIL) | Restylane® Silk (RS) |
|---|---|---|
| Very much improved (+3) | 53.8 | 53.8 |
| Much improved (+2) | 37.3 | 28.8 |
| Improved (+1) | 8.9 | 17.3 |
| No change (0) | 0.0 | 0.0 |
| Worse (-1) | 0.0 | 0.0 |
| Much worse (-2) | 0.0 | 0.0 |
| Very much worse (-3) | 0.0 | 0.0 |
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).
| score on a scale | Belotero® Intense Lidocaine (BIL) | Restylane® Silk (RS) |
|---|---|---|
| Change From Baseline in Rasch-transformed Score of the FACE-Q Satisfaction With Lips | 50.7 ± 22.00 | 51.7 ± 23.18 |
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.
| Participants | Belotero® Intense Lidocaine (BIL) | Restylane® Silk (RS) |
|---|---|---|
| Related Serious TEAEs | 0 | 0 |
| Related Delayed-onset TEAEs | 4 | 3 |
Collected over BIL Treatment: Up to 60 weeks; RS Treatment: Up to 48 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Belotero® Intense Lidocaine (BIL) | 0/165 (0%) | 2/165 (1.2%) | 41/165 (24.8%) |
| Restylane® Silk (RS) | 0/55 (0%) | 0/55 (0%) | 12/55 (21.8%) |
| Event | Belotero® Intense Lidocaine (BIL) | Restylane® Silk (RS) |
|---|---|---|
| CholecystitisHepatobiliary disorders | 1/165 | 0/55 |
| Femur fractureInjury, poisoning and procedural complications | 1/165 | 0/55 |
| Event | Belotero® Intense Lidocaine (BIL) | Restylane® Silk (RS) |
|---|---|---|
| Injection site massGeneral disorders | 27/165 | 6/55 |
| Injection site indurationGeneral disorders | 12/165 | 4/55 |
| COVID-19Infections and infestations | 7/165 | 3/55 |
| Visual acuity tests abnormalInvestigations | 6/165 | 3/55 |
The safety evaluation set (SES) included all subjects who were exposed to the investigational medical device (IMD) or comparator device at least once.
| Age, Continuous(years) | Belotero® Intense Lidocaine (BIL) | Restylane® Silk (RS) | Total |
|---|---|---|---|
| Mean | 46.5 ± 12.26 | 47.3 ± 10.26 | 46.7 ± 11.77 |
| Sex: Female, Male(Participants) | Belotero® Intense Lidocaine (BIL) | Restylane® Silk (RS) | Total |
|---|---|---|---|
| Female | 161 | 51 | 212 |
| Male | 4 | 4 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Belotero® Intense Lidocaine (BIL) | Restylane® Silk (RS) | Total |
|---|---|---|---|
| Hispanic or Latino | 33 | 14 | 47 |
| Not Hispanic or Latino | 132 | 41 | 173 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Belotero® Intense Lidocaine (BIL) | Restylane® Silk (RS) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 2 | 8 |
| White | 153 | 50 | 203 |
| More than one race | 5 | 2 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2023 to primary completion in Oct 2023, 7 months.
Results were first posted in Aug 2026, 2 years 10 months after primary completion. A results delay was requested in Oct 2024.
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