Status:
COMPLETED
A Pilot Study to Assess the Effectiveness and Safety of Belotero Balance® Injection for Volume Augmentation of the Infraorbital Hollow
Lead Sponsor:
Merz North America, Inc.
Conditions:
Correction of Volume Loss in the Infraorbital Hollow Area
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The pilot study aims to define safety, effectiveness, and patient-reported outcomes for Belotero Balance® use in the infraorbital hollows.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2020
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03777917
Start Date
December 27 2018
End Date
March 11 2020
Last Update
November 14 2023
Active Locations (3)
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1
Center for Sight, Merz Investigational Site #0010414
Sarasota, Florida, United States, 34239
2
Private Practice, Merz Investigational Site #0010413
New York, New York, United States, 10021
3
Center for Laser and Facial Surgery, Merz Investigational Site #0010353
Nashville, Tennessee, United States, 37203