A Study of Belotero® Intense Lidocaine for Lip Augmentation
BILUS
A Prospective, Multicenter, Randomized, Comparator-controlled, Evaluator-blinded Study to Evaluate the Safety and Effectiveness of Belotero® Intense Lidocaine for Lip Augmentation
1 other identifier
interventional
220
2 countries
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2023
CompletedFirst Submitted
Initial submission to the registry
March 6, 2023
CompletedFirst Posted
Study publicly available on registry
March 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2024
CompletedResults Posted
Study results publicly available
August 18, 2026
CompletedAugust 18, 2026
July 1, 2026
8 months
March 6, 2023
July 24, 2026
July 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Baseline, Week 8
Secondary Outcomes (4)
Percentage of Subjects With Investigator's Global Aesthetic Improvement Scale (iGAIS) Scores
At Week 8
Percentage of Subjects With Subject's GAIS Scores (sGAIS)
At Week 8
Change From Baseline in Rasch-transformed Score of the FACE-Q Satisfaction With Lips
Baseline, Week 8
Number of Subjects With Related Serious or Related Delayed-onset Treatment Emergent Adverse Events (TEAEs)
Up to 48 weeks
Study Arms (2)
Belotero® Intense Lidocaine
EXPERIMENTALLips injected with BIL.
Restylane® Silk
ACTIVE COMPARATORLips injected with RS.
Interventions
Dermal hyaluronic acid (HA) filler for lip augmentation.
Eligibility Criteria
You may qualify if:
- Desires lip augmentation to correct volume and has very thin to medium upper and/or lower lip deficit
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Merz Investigation Site #0010463
Redondo Beach, California, 90277, United States
Merz Investigation Site #0010299
Santa Monica, California, 90404, United States
Merz Investigation Site #0010358
Vista, California, 92083, United States
Merz Investigation Site #0010170
Washington D.C., District of Columbia, 20037, United States
Merz Investigation Site #0010101
Coral Gables, Florida, 33146, United States
Merz Investigation Site #0010464
Alpharetta, Georgia, 30005, United States
Merz Investigation Site #0010446
Atlanta, Georgia, 30342, United States
Merz Investigation Site #0010466
Chicago, Illinois, 60654, United States
Merz Investigation Site #0010472
Purchase, New York, 10577, United States
Merz Investigation Site #0010468
Ardmore, Pennsylvania, 19003, United States
Merz Investigation Site #0010097
Nashville, Tennessee, 37215, United States
Merz Investigation Site #0010322
Austin, Texas, 78746, United States
Merz Investigation Site #0010467
Austin, Texas, 78746, United States
Merz Investigation Site #0010436
San Juan, 00917, Puerto Rico
Results Point of Contact
- Title
- Public Disclosure Manager
- Organization
- Merz Aesthetics
Study Officials
- STUDY DIRECTOR
Merz Medical Expert
Merz North America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2023
First Posted
March 17, 2023
Study Start
March 3, 2023
Primary Completion
October 16, 2023
Study Completion
September 26, 2024
Last Updated
August 18, 2026
Results First Posted
August 18, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share