Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow

• Confirm the effectiveness of Belotero Balance® (+) Lidocaine (BBL) injection for the correction of volume loss in the infraorbital hollow (IOH) area by demonstrating superiority to untreated control.
• Confirm the safety of BBL injection for the correction of volume loss in the IOH area.

Study Overview

• Status: Completed
• Conditions: Volume Loss in the Infraorbital Hollow Area
• Intervention / Treatment: Device: Belotero Balance (+) Lidocaine, needle; Device: Belotero Balance (+) Lidocaine, cannula; Device: Untreated-control / delayed-treatment, needle; Device: Untreated-control / delayed-treatment, cannulas

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • Jose Raul Montes Eyes and Facial Rejuvenation, Merz Investigational Site #0010436
• United States
  • California
    • Solana Beach, California, United States, 92075
      • Art of Skin MD, Merz Investigational Site #0010444
    • Vista, California, United States, 92083
      • Moradi MD Face Beautiful Inc., Merz Investigational Site #0010358
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • MetroDerm / Atlanta Center for Clinical Research, Merz Investigational Site #0010446
  • New York
    • Brooklyn, New York, United States, 11229
      • Project Glammers, Merz Investigational Site #0010443
    • Mount Kisco, New York, United States, 10549
      • The Center for Dermatology, Cosmetic & Laser Surgery, Merz Investigational Site #0010442
    • West Islip, New York, United States, 11795
      • Mariwalla Dermatology, Merz Investigational Site #0010445
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • HKB Surgeons, Merz Investigational Site #0010447
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Nashville Centre for Laser & Facial Surgery, Merz Investigational Site #0010353

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Is a candidate for bilateral IOH treatment.
• Has symmetrical right and left IOHs with the same MIHAS score of 2 or 3 (moderate or severe), as assessed live by the blinded evaluator.

Exclusion Criteria:

• Prior lower-eyelid surgery, including orbital or midface surgery, or a permanent implant or graft in the midfacial region that could interfere with effectiveness assessments.
• Previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the midfacial region.
• Previous lower-eyelid and/or malar-region treatments with any dermal fillers (e.g., collagen, hyaluronic acid (HA), calcium hydroxyapatite, poly L-lactic acid (PLLA)) within the past 24 months.
• Any other medical condition with the potential to interfere with the study outcome assessments or compromise subject safety.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment, needle	Device: Belotero Balance (+) Lidocaine, needle; Injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles
Experimental: Treatment, cannula	Device: Belotero Balance (+) Lidocaine, cannula; Injection of Belotero Balance (+) Lidocaine into the infraorbital hollows using cannulas
Other: Untreated-control / delayed-treatment, needle	Device: Untreated-control / delayed-treatment, needle; Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles)
Other: Untreated-control / delayed-treatment, cannula	Device: Untreated-control / delayed-treatment, cannulas; Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using cannulas)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate Based on Merz Infraorbital Hollow Assessment Scale (MIHAS) at Week 8	Responder rate was defined as percentage of subjects with treatment response at Week 8 on MIHAS, as assessed live by a blinded evaluator. Responders were defined as subjects who achieved greater than or equal to (>=) 1 grade improvement on both IOHs on the MIHAS. MIHAS (to assess infraorbital hollow) was a 5-point scale ranging as: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (extreme). A higher score indicated extreme signs of hollowing. This analysis was done using multiple imputation method to impute missing MIHAS scores. Percentage of subjects with response at Week 8 and corresponding confidence intervals were average values obtained from the multiple imputation approach.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Global Aesthetic Improvement Scale (GAIS) Score at Week 8, as Assessed by the Treating Investigator	The GAIS is a 7-point scale 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. An improvement on the GAIS was classified as "improved", "much improved", or "very much improved.	Week 8
Percentage of Subjects With GAIS Score at Week 8, as Assessed by the Subject	The GAIS is a 7-point scale 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 subject. An improvement on the GAIS was classified as "improved", "much improved", or "very much improved.	Week 8
Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes at Week 8	The FACE-Q is a set of standardized patient-reported outcome scales for subjects undergoing facial cosmetic procedures. Subjects answered 7 questions of the FACE-Q satisfaction with eyes using a 4- point scale where: 1(very dissatisfied), 2 (somewhat dissatisfied), 3 (somewhat satisfied), 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 Treatment-Emergent Adverse Events (TEAEs) Related to BBL	TEAEs are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment. A TEAE was considered to be "related" if a causal relationship between BBL and the TEAE is at least reasonably possible.	BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks
Number of Subjects With Treatment-Emergent Serious Adverse Events (TESAEs) Related to BBL	TESAEs included TEAEs that resulted in death, required either inpatient hospitalization or the prolongation of hospitalization, were life-threatening, resulted in a persistent or significant disability/incapacity or resulted in a congenital anomaly/birth defect. A TESAE was considered to be "related" if a causal relationship between BBL and the TESAE is at least reasonably possible.	BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 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): August 31, 2020
• Primary Completion (Actual): April 8, 2021
• Study Completion (Actual): June 21, 2022

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

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; Immunologic Factors; Protective Agents; Membrane Transport Modulators; Adjuvants, Immunologic; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Viscosupplements; Lidocaine; Hyaluronic Acid
• Other Study ID Numbers: M930121002

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
• product manufactured in and exported from the U.S.: No