Clinical trial NCT03777917: A Pilot Study to Assess the Effectiveness and Safety of Belotero Balance® Injection for Volume Augmentation of the Infraorbital Hollow
Official title: Pilot Study to Assess the Effectiveness and Safety of Belotero Balance® Injection for Volume Augmentation of the Infraorbital Hollow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Correction of Volume Loss in the Infraorbital Hollow Area
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-17
Enrollment: 66
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Responder Rate Compared to the Untreated Control Group According to the Merz Infraorbital Hollow Assessment Scale (MIHAS).
timeFrame: Baseline up to Month 2
Secondary outcomes:
measure: Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes
timeFrame: Baseline and Month 2
measure: Global Aesthetic Improvement Scale (GAIS) Scores
timeFrame: Baseline up to Month 2
measure: GAIS Scores as Assessed by Participants
timeFrame: Baseline up to Month 2
measure: Responder Rate in the Treatment Group and the Untreated Control Group According to MIHAS as Assessed by Independent Panel Reviewers
timeFrame: Baseline up to Month 2
measure: Number of Participants Reporting One or More Device and/or Injection Related Treatment-emergent Adverse Events (TEAEs) and Device and/or Injection Related Serious TEAEs
timeFrame: Treatment Group: Baseline up to Month 13; Untreated Control Group: Baseline up to Month 2
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Center for Sight, Merz Investigational Site #0010414
state: Florida
city: New York
country: United States
facility: Private Practice, Merz Investigational Site #0010413
state: New York
city: Nashville
country: United States
facility: Center for Laser and Facial Surgery, Merz Investigational Site #0010353
state: Tennessee
Study officials:
affiliation: Merz North America, Inc.
name: Merz Medical Expert
role: STUDY_DIRECTOR
References:
citation: Biesman B, Verma A, Cheng N, Duncan A. Development and Validation of a Photonumeric Scale for Evaluation of Infraorbital Hollowing. J Drugs Dermatol. 2023 Jan 1;22(1):74-81. doi: 10.36849/JDD.7191.