A Pilot Study to Assess the Effectiveness and Safety of Belotero Balance® Injection for Volume Augmentation of the Infraorbital Hollow

Pilot Study to Assess the Effectiveness and Safety of Belotero Balance® Injection for Volume Augmentation of the Infraorbital Hollow

The pilot study aims to define safety, effectiveness, and patient-reported outcomes for Belotero Balance® use in the infraorbital hollows.

Study Overview

• Status: Completed
• Conditions: Correction of Volume Loss in the Infraorbital Hollow Area
• Intervention / Treatment: Device: Belotero Balance®

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Sarasota, Florida, United States, 34239
      • Center for Sight, Merz Investigational Site #0010414
  • New York
    • New York, New York, United States, 10021
      • Private Practice, Merz Investigational Site #0010413
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Center for Laser and Facial Surgery, Merz Investigational Site #0010353

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Has right and left infraorbital hollow (IOH) volume deficit with a rating of 2 or 3 (moderate or severe) on the MIHAS.
• Has the same MIHAS score on both IOHs (i.e., IOHs are symmetrical).
• Is at least 22 years of age.

Exclusion Criteria:

• Ever been treated with fat injections or permanent and/or semi-permanent dermal fillers in the midfacial region.
• Received lower eyelid and/or malar region treatments with any absorbable or temporary fillers such as porcine-based collagen fillers, hyaluronic acid (HA) products, RADIESSE®, poly L-lactic acid (PLLA) or received mesotherapy treatment to the area within the past 24 months or plans to receive such treatments during participation in the study.

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
No Intervention: No treatment
Experimental: Belotero Balance®	Device: Belotero Balance®; Belotero® Balance for infraorbital hollows. Mode of application: subdermal injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate Compared to the Untreated Control Group According to the Merz Infraorbital Hollow Assessment Scale (MIHAS).	MIHAS was a 5 point scale ranging as: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (extreme). Responder rate was defined as percentage of participants with treatment response who achieved greater than or equal to (>=) 1 grade improvement on both IOHs on the MIHAS.	Baseline up to Month 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes	The FACE-Q is a set of standardized patient-reported outcome scales for participants undergoing facial cosmetic procedures. The participants answered 7 questions of the FACE-Q satisfaction with eyes scale using a 4 point scale where: 1 (very dissatisfied), 2 (somewhat dissatisfied), 3 (somewhat satisfied), 4 (very satisfied). The sum scores of the FACE-Q satisfaction with eyes questionnaire and the Rasch-transformed scores ranging from 0 to 100 were summarized by treatment arm. Higher scores reflected a better outcome.	Baseline and Month 2
Global Aesthetic Improvement Scale (GAIS) Scores	7 point rating scale ranging from: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), -3 (very much worse).	Baseline up to Month 2
GAIS Scores as Assessed by Participants	Participants evaluated their IOHs on 7 point rating scale ranging from: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), -3 (very much worse).	Baseline up to Month 2
Responder Rate in the Treatment Group and the Untreated Control Group According to MIHAS as Assessed by Independent Panel Reviewers	MIHAS was a 5 point scale ranging as: 0 (none to minimal), 1 (mild), 2 (moderate), 3 (severe), 4 (extreme). Responder rate was defined as percentage of participants with treatment response who achieved >=1 improvement on both IOHs compared to baseline. A participant was considered a responder if a treatment response of at least a 1-point change on both IOHs was determined by independent panel reviewers.	Baseline up to Month 2
Number of Participants Reporting One or More Device and/or Injection Related Treatment-emergent Adverse Events (TEAEs) and Device and/or Injection Related Serious TEAEs		Treatment Group: Baseline up to Month 13; Untreated Control Group: Baseline up to Month 2

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Biesman B, Verma A, Cheng N, Duncan A. Development and Validation of a Photonumeric Scale for Evaluation of Infraorbital Hollowing. J Drugs Dermatol. 2023 Jan 1;22(1):74-81. doi: 10.36849/JDD.7191.

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2018
• Primary Completion (Actual): June 18, 2019
• Study Completion (Actual): March 11, 2020

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: M930121001

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