NCT03777917

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

December 27, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2020

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

September 2, 2022

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

December 4, 2018

Results QC Date

June 14, 2022

Last Update Submit

November 10, 2023

Conditions

Correction of Volume Loss in the Infraorbital Hollow Area

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline up to Month 2

Secondary Outcomes (5)

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

    Baseline and Month 2

  • Global Aesthetic Improvement Scale (GAIS) Scores

    Baseline up to Month 2

  • GAIS Scores as Assessed by Participants

    Baseline up to Month 2

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

    Baseline up to Month 2

  • 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

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

Study Arms (2)

Belotero Balance®

EXPERIMENTAL
Device: Belotero Balance®

No treatment

NO INTERVENTION

Interventions

Belotero Balance®DEVICE

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

Belotero Balance®

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Center for Sight, Merz Investigational Site #0010414

Sarasota, Florida, 34239, United States

Location

Private Practice, Merz Investigational Site #0010413

New York, New York, 10021, United States

Location

Center for Laser and Facial Surgery, Merz Investigational Site #0010353

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

  • 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.

    PMID: 36607759BACKGROUND

Results Point of Contact

Title
Public Disclosure Manager
Organization
Merz Pharmaceuticals GmbH
Aesthetic.Trials@merz.com
+49 69 1503 1

Study Officials

  • Merz Medical Expert

    Merz North America, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2018

First Posted

December 17, 2018

Study Start

December 27, 2018

Primary Completion

June 18, 2019

Study Completion

March 11, 2020

Last Updated

November 14, 2023

Results First Posted

September 2, 2022

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(3)