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

Merz Pharmaceuticals

Status: Completed

Conditions: Correction of Volume Loss in the Infraorbital Hollow Area

Treatments: Device: Belotero Balance®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03777917

M930121001

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Belotero Balance®

Experimental group

Treatment:

Device: Belotero Balance®

No treatment

No Intervention group