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

Not Applicable

Completed

• Conditions: Correction of Volume Loss in the Infraorbital Hollow Area

• Registration Number: NCT03777917
• Lead Sponsor: Merz North America, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-14
• Study First Posted: 2018-12-17
• Study Start: 2018-12-27
• Primary Completion: 2019-06-18
• Study Completion: 2020-03-11
• Disposition First Submitted: 2020-06-15
• Results First Submitted: 2022-06-14
• Results First Submitted QC: 2022-09-01
• Disposition First Submitted QC: 2022-09-01
• Results First Posted: 2022-09-02
• Disposition First Posted: 2022-09-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Responder Rate Compared to the Untreated Control Group According to the Merz Infraorbital Hollow Assessment Scale (MIHAS).	Baseline up to Month 2	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes	Baseline and Month 2	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.
GAIS Scores as Assessed by Participants	Baseline up to Month 2	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).
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
Global Aesthetic Improvement Scale (GAIS) Scores	Baseline up to Month 2	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).
Responder Rate in the Treatment Group and the Untreated Control Group According to MIHAS as Assessed by Independent Panel Reviewers	Baseline up to Month 2	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.

Trial Locations

Locations (3)

Center for Sight, Merz Investigational Site #0010414; 🇺🇸 Sarasota, Florida, United States

Private Practice, Merz Investigational Site #0010413; 🇺🇸 New York, New York, United States

Center for Laser and Facial Surgery, Merz Investigational Site #0010353; 🇺🇸 Nashville, Tennessee, United States