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

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.

Study Overview

• Status: Completed
• Conditions: Lip Augmentation
• Intervention / Treatment: Device: Belotero® Intense Lidocaine; Device: Restylane® Silk

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 Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • Merz Investigation Site #0010436
• United States
  • California
    • Redondo Beach, California, United States, 90277
      • Merz Investigation Site #0010463
    • Santa Monica, California, United States, 90404
      • Merz Investigation Site #0010299
    • Vista, California, United States, 92083
      • Merz Investigation Site #0010358
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • Merz Investigation Site #0010170
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Merz Investigation Site #0010101
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Merz Investigation Site #0010464
    • Atlanta, Georgia, United States, 30342
      • Merz Investigation Site #0010446
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Merz Investigation Site #0010466
  • New York
    • Purchase, New York, United States, 10577
      • Merz Investigation Site #0010472
  • Pennsylvania
    • Ardmore, Pennsylvania, United States, 19003
      • Merz Investigation Site #0010468
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Merz Investigation Site #0010097
  • Texas
    • Austin, Texas, United States, 78746
      • Merz Investigation Site #0010322
    • Austin, Texas, United States, 78746
      • Merz Investigation Site #0010467

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Desires lip augmentation to correct volume and has very thin to medium upper and/or lower lip deficit

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Belotero® Intense Lidocaine; Lips injected with BIL.	Device: Belotero® Intense Lidocaine; Dermal hyaluronic acid (HA) filler for lip augmentation.
Active Comparator: Restylane® Silk; Lips injected with RS.	Device: Restylane® Silk; HA gel for lip augmentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	Up to 48 weeks

Collaborators and Investigators

• Sponsor: Merz North America, Inc.
• Investigators: Study Director: Merz Medical Expert, Merz North America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Actual): October 16, 2023
• Study Completion (Actual): September 26, 2024

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: July 24, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: M930041001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes