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

Merz Pharmaceuticals

Status: Completed

Conditions: Volume Loss in the Infraorbital Hollow Area

Treatments: Device: Untreated-control / delayed-treatment, cannulas; Device: Untreated-control / delayed-treatment, needle; Device: Belotero Balance (+) Lidocaine, cannula; Device: Belotero Balance (+) Lidocaine, needle

Study type: Interventional

Funder types: Industry

Identifiers

NCT04594239

M930121002

Details and patient eligibility

About

• 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.

Enrollment: 150 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 4 patient groups

Treatment, needle

Experimental group

Treatment:

Device: Belotero Balance (+) Lidocaine, needle

Treatment, cannula

Experimental group

Treatment:

Device: Belotero Balance (+) Lidocaine, cannula

Untreated-control / delayed-treatment, needle

Other group

Treatment:

Device: Untreated-control / delayed-treatment, needle

Untreated-control / delayed-treatment, cannula

Other group

Treatment:

Device: Untreated-control / delayed-treatment, cannulas