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Completed

NCT Number: NCT03777917

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

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

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Key information

Conditions

Correction of Volume Loss in the Infraorbital Hollow Area

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Sight, Merz Investigational Site #0010414, Sarasota, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Belotero Balance®

Device

Belotero® Balance for infraorbital hollows. Mode of application: subdermal injection.

Primary outcomes

  1. Responder Rate Compared to the Untreated Control Group According to the Merz Infraorbital Hollow Assessment Scale (MIHAS).

    Time frame: Baseline up to Month 2

    MIHAS was a 5 point scale ranging as: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (extreme). Responder rate was defined as percentage of participants with treatment response who achieved greater than or equal to (>=) 1 grade improvement on both IOHs on the MIHAS.

Secondary outcomes

  1. Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes

    Time frame: Baseline and Month 2

    The FACE-Q is a set of standardized patient-reported outcome scales for participants undergoing facial cosmetic procedures. The participants answered 7 questions of the FACE-Q satisfaction with eyes scale using a 4 point scale where: 1 (very dissatisfied), 2 (somewhat dissatisfied), 3 (somewhat satisfied), 4 (very satisfied). The sum scores of the FACE-Q satisfaction with eyes questionnaire and the Rasch-transformed scores ranging from 0 to 100 were summarized by treatment arm. Higher scores reflected a better outcome.

  2. Global Aesthetic Improvement Scale (GAIS) Scores

    Time frame: Baseline up to Month 2

    7 point rating scale ranging from: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), -3 (very much worse).

  3. GAIS Scores as Assessed by Participants

    Time frame: Baseline up to Month 2

    Participants evaluated their IOHs on 7 point rating scale ranging from: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), -3 (very much worse).

  4. Responder Rate in the Treatment Group and the Untreated Control Group According to MIHAS as Assessed by Independent Panel Reviewers

    Time frame: Baseline up to Month 2

    MIHAS was a 5 point scale ranging as: 0 (none to minimal), 1 (mild), 2 (moderate), 3 (severe), 4 (extreme). Responder rate was defined as percentage of participants with treatment response who achieved >=1 improvement on both IOHs compared to baseline. A participant was considered a responder if a treatment response of at least a 1-point change on both IOHs was determined by independent panel reviewers.

  5. 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

    Time frame: Treatment Group: Baseline up to Month 13; Untreated Control Group: Baseline up to Month 2

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 17, 2018
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.