N/A
N=66
A Pilot Study to Assess the Effectiveness and Safety of Belotero Balance® Injection for Volume Augmentation of the Infraorbital Hollow
Correction of Volume Loss in the Infraorbital Hollow Area
Bottom Line
View on ClinicalTrials.gov: NCT03777917 ↗Enrolled (actual)
66
Serious AEs
1.5%
Results posted
Sep 2022
Primary outcome: Primary: Responder Rate Compared to the Untreated Control Group According to the Merz Infraorbital Hollow Assessment Scale (MIHAS). — 81.6; 9.5 percentage of participants — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Belotero Balance® (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Merz North America, Inc.
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate Compared to the Untreated Control Group According to the Merz Infraorbital Hollow Assessment Scale (MIHAS). |
81.6; 9.5 | < 0.0001 sig |
| SECONDARY Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes |
28.8; 2.1 | — |
| SECONDARY Global Aesthetic Improvement Scale (GAIS) Scores |
23; 4; 11; 0; 0; 0 | — |
| SECONDARY GAIS Scores as Assessed by Participants |
11; 9; 15; 2; 1; 0 | — |
| SECONDARY Responder Rate in the Treatment Group and the Untreated Control Group According to MIHAS as Assessed by Independent Panel Reviewers |
36.8; 9.5 | — |
| SECONDARY 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 |
2; 0; 0; 0 | — |
Summary
The pilot study aims to define safety, effectiveness, and patient-reported outcomes for Belotero Balance® use in the infraorbital hollows.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03777917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.