N/A
N=150
Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow
Volume Loss in the Infraorbital Hollow Area
Bottom Line
View on ClinicalTrials.gov: NCT04594239 ↗Enrolled (actual)
150
Serious AEs
0.5%
Results posted
Jan 2024
Primary outcome: Primary: Responder Rate Based on Merz Infraorbital Hollow Assessment Scale (MIHAS) at Week 8 — 80.6; 87.4; 73.7; 1.9 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Belotero Balance (+) Lidocaine, needle (Device); Belotero Balance (+) Lidocaine, cannula (Device); Untreated-control / delayed-treatment, needle (Device); Untreated-control / delayed-treatment, cannulas (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Merz North America, Inc.
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate Based on Merz Infraorbital Hollow Assessment Scale (MIHAS) at Week 8 |
80.6; 87.4; 73.7; 1.9 | — |
| SECONDARY Percentage of Subjects With Global Aesthetic Improvement Scale (GAIS) Score at Week 8, as Assessed by the Treating Investigator |
47.8; 44.2; 41.3; 25.6; 8.7; 30.2 | — |
| SECONDARY Percentage of Subjects With GAIS Score at Week 8, as Assessed by the Subject |
34.8; 30.2; 45.7; 37.2; 19.6; 32.6 | — |
| SECONDARY Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes at Week 8 |
27.4; 24.6 | — |
| SECONDARY Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Related to BBL |
5; 6; 1; 1 | — |
| SECONDARY Number of Subjects With Treatment-Emergent Serious Adverse Events (TESAEs) Related to BBL |
0; 0; 0; 0 | — |
Summary
* 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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04594239). 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.