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Correction of Volume Loss in the Infr...

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

Sponsored by Merz North America, Inc.

About this trial

Last updated 3 years ago

Study ID

M930121002

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
22 to 65 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

- Confirm the effectiveness of Belotero Balance® (+) Lidocaine injection for the correction of volume loss in the infraorbital hollow (IOH) area by demonstrating superiority to untreated control - Identify the incidence of adverse events (AEs) and serious adverse events (SAEs)

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status