Lip AugmentationBILUSNCT05773066
A Study of Belotero® Intense Lidocaine for Lip Augmentation
A study testing Belotero® Intense Lidocaine and Restylane® Silk in people with Lip Augmentation, run by Merz North America, Inc. at 14 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Lip Augmentation
- What is being tested?
- Belotero® Intense Lidocaine and Restylane® Silk
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 3 Mar 2023to 26 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Desires lip augmentation to correct volume and has very thin to medium upper and/or lower lip deficit
Who cannot join
- Any previous surgery, including plastic surgery or permanent implant or graft in the lower third part of the face
- Any previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the face
- Any treatment with porcine-based collagen fillers or with Juvéderm® Voluma XC, Restylane® Lyft Lidocaine, Calcium hydroxyapatite (CaHA) within the past 24 months and/or other dermal fillers within the past 12 months in the lips, in the lower third part of the face, and/or the nose
- Any previous treatment with dermal therapies within the past 3 months in the lower third part of the face
- Has undergone oral surgery in the past 30 days
- Lip volume deficit due to medical conditions
- Known history of allergic/anaphylactic reactions/hypersensitivity to lidocaine or any of the device components
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Merz Investigation Site #0010464
Alpharetta, Georgia, 30005
Merz Investigation Site #0010468
Ardmore, Pennsylvania, 19003
Merz Investigation Site #0010446
Atlanta, Georgia, 30342
Merz Investigation Site #0010322
Austin, Texas, 78746
Merz Investigation Site #0010467
Austin, Texas, 78746
Merz Investigation Site #0010466
Chicago, Illinois, 60654
Merz Investigation Site #0010101
Coral Gables, Florida, 33146
Merz Investigation Site #0010097
Nashville, Tennessee, 37215
Merz Investigation Site #0010472
Purchase, New York, 10577
Merz Investigation Site #0010463
Redondo Beach, California, 90277
Merz Investigation Site #0010299
Santa Monica, California, 90404
Merz Investigation Site #0010358
Vista, California, 92083
Merz Investigation Site #0010170
Washington D.C., District of Columbia, 20037
About this study
Official title: A Prospective, Multicenter, Randomized, Comparator-controlled, Evaluator-blinded Study to Evaluate the Safety and Effectiveness of Belotero® Intense Lidocaine for Lip Augmentation
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.
Read the detailed description
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.
- Conditions
- Lip Augmentation
- Being tested
- Belotero® Intense Lidocaine, Restylane® Silk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belotero® Intense LidocaineDevice
Dermal hyaluronic acid (HA) filler for lip augmentation.
Restylane® SilkDevice
HA gel for lip augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Belotero® Intense Lidocaine | Experimental | Lips injected with BIL. Receives: Device: Belotero® Intense Lidocaine |
| Restylane® Silk | Active comparator | Lips injected with RS. Receives: Device: Restylane® Silk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 8
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start3 Mar 2023
- Primary completion16 Oct 2023
- Study completion26 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lip AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773066
- Sponsor's protocol ID
- M930041001
- Acronym
- BILUS
- Status last verified
- Jul 2026
- First submitted
- 6 Mar 2023
- Last updated
- 18 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Comparator-controlled, Evaluator-blinded Study to Evaluate the Safety and Effectiveness of Belotero® Intense Lidocaine for Lip Augmentation
- ClinicalTrials.gov ID
- NCT05773066
- Acronym / sponsor ID
- BILUS / M930041001
- Conditions
- Lip Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Posted 18 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belotero® Intense Lidocaine | Experimental | Device: Belotero® Intense LidocaineLips injected with BIL. |
| Restylane® Silk | Active comparator | Device: Restylane® SilkLips injected with RS. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Desires lip augmentation to correct volume and has very thin to medium upper and/or lower lip deficit
Key exclusion criteria (7 listed)
- Any previous surgery, including plastic surgery or permanent implant or graft in the lower third part of the face
- Any previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the face
- Any treatment with porcine-based collagen fillers or with Juvéderm® Voluma XC, Restylane® Lyft Lidocaine, Calcium hydroxyapatite (CaHA) within the past 24 months and/or other dermal fillers within the past 12 months in the lips, in the lower third part of the face, and/or the nose
- Any previous treatment with dermal therapies within the past 3 months in the lower third part of the face
- Has undergone oral surgery in the past 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belotero® Intense LidocaineDermal hyaluronic acid (HA) filler for lip augmentation. | Device | Belotero® Intense Lidocaine |
| Restylane® SilkHA gel for lip augmentation. | Device | Restylane® Silk |
Primary outcome
Responder Rate at Week 8, According to the MLFAS
Time frame: At Week 8
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.
Mean Change of Treated Lips From Baseline to Week 8, According to the Merz Lip Fullness Assessment Scale (MLFAS)
Time frame: Baseline, Week 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.
4 secondary outcomes
Percentage of Subjects With Investigator's Global Aesthetic Improvement Scale (iGAIS) Scores
Time frame: At Week 8
Percentage of Subjects With Subject's GAIS Scores (sGAIS)
Time frame: At Week 8
Change From Baseline in Rasch-transformed Score of the FACE-Q Satisfaction With Lips
Time frame: Baseline, Week 8
Number of Subjects With Related Serious or Related Delayed-onset Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merz Medical Expert study director
Merz North America, Inc.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Belotero® Intense Lidocaine and Restylane® Silk in people with Lip Augmentation, run by Merz North America, Inc. at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Rate at Week 8, According to the MLFAS (time frame: At Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.