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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-27

Study Completion Date

2020-03-11

Brief Summary

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

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Detailed Description

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Conditions

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Correction of Volume Loss in the Infraorbital Hollow Area

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Belotero Balance®

Group Type EXPERIMENTAL

Belotero Balance®

Intervention Type DEVICE

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

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Belotero Balance®

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No