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

Completed · Not applicable

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

In brief

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

Key facts

Study ID

NCT03777917

Run by

Merz North America, Inc.

People needed

66

Starts

2018-12-27

Expected to finish

2020-03-11

Last updated by the study team

2023-11-14

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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