[Trial of device that is not approved or cleared by the U.S. FDA] (BILUS)

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: Withheld
• 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.

• 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, 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?

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
Mean Change of Treated Lips From Baseline to Visit 3 (V3), According to the Merz Lip Fullness Assessment Scale (MLFAS)	MLFAS is a validated 5-grade scale used to assess the volume of the upper and lower lips, where Grade 0=thin lips with minimal volume and Grade 4=very full lips with significant volume. A positive number change from baseline indicates improvement.	Baseline (Day 1) and Week 8 post last injection, up to 12 Weeks (V3)
Responder Rates at V3, According to the MLFAS	Response is defined as greater than or equal to (>=) 1-point improvement on subject's treated lips compared to baseline. MLFAS is a validated 5-grade scale used to assess the volume of the upper and lower lips, where Grade 0=thin lips with minimal volume and Grade 4=very full lips with significant volume. A positive number change from baseline indicates improvement.	Week 8 post last injection, up to 12 Weeks (V3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator's Global Aesthetic Improvement Scale (GAIS) Scores	The treating investigator will assess the subject's treated lips compared to pre-treatment photos using the 7-point GAIS, where +3=Very much improved and -3=Very much worse.	Week 8 post last injection, up to 12 Weeks (V3)
Subject's GAIS Scores	Subjects will assess their treated lips compared to pre-treatment photos using the 7-point GAIS, where +3=Very much improved and -3=Very much worse.	Week 8 post last injection, up to 12 Weeks (V3)
Change From Baseline in Rasch-transformed Score of the FACE-Q Satisfaction with Lips	FACE-Q is a set of validated, standardized patient-reported outcome scales for subjects receiving facial cosmetic procedures. The subject will rate the level of satisfaction with their lips by answering questions using a scale where 1=Very Dissatisfied and 4=Very Satisfied. Sum scores will then be Rasch-transformed as 0 to 100, where higher scores indicate better outcome.	Baseline (Day 1) and Week 8 post last injection, up to 12 Weeks (V3)
Number of Subjects With Related Serious or Related Delayed-onset Treatment Emergent Adverse Events (TEAEs)	TEAEs are defined as adverse events (AEs) with onset or worsening on or after date of first administration of BIL. A serious TEAE is 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 are those with onset greater than (>) 21 days after last treatment.	Baseline (Day 1) up to Week 48 post last treatment, up to 52 Weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: March 3, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 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): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: September 1, 2023

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

Drug and device information, study documents

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