Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow

Merz North America, Inc.150 enrolled

Overview

* Confirm the effectiveness of Belotero Balance® (+) Lidocaine (BBL) injection for the correction of volume loss in the infraorbital hollow (IOH) area by demonstrating superiority to untreated control. * Confirm the safety of BBL injection for the correction of volume loss in the IOH area.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Volume Loss in the Infraorbital Hollow Area

Interventions

Belotero Balance (+) Lidocaine, needleDEVICE

Injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles

Belotero Balance (+) Lidocaine, cannulaDEVICE

Injection of Belotero Balance (+) Lidocaine into the infraorbital hollows using cannulas

Untreated-control / delayed-treatment, needleDEVICE

Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles)

Eligibility

Sex: ALLMin age: 22 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Is a candidate for bilateral IOH treatment. * Has symmetrical right and left IOHs with the same MIHAS score of 2 or 3 (moderate or severe), as assessed live by the blinded evaluator. Exclusion Criteria: * Prior lower-eyelid surgery, including orbital or midface surgery, or a permanent implant or graft in the midfacial region that could interfere with effectiveness assessments. * Previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the midfacial region. * Previous lower-eyelid and/or malar-region treatments with any dermal fillers (e.g., collagen, hyaluronic acid (HA), calcium hydroxyapatite, poly L-lactic acid (PLLA)) within the past 24 months. * Any other medical condition with the potential to interfere with the study outcome assessments or compromise subject safety.

Locations (9)

Art of Skin MD, Merz Investigational Site #0010444

Solana Beach, California, United States

Moradi MD Face Beautiful Inc., Merz Investigational Site #0010358

Vista, California, United States

MetroDerm / Atlanta Center for Clinical Research, Merz Investigational Site #0010446

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Responder Rate Based on Merz Infraorbital Hollow Assessment Scale (MIHAS) at Week 8

Responder rate was defined as percentage of subjects with treatment response at Week 8 on MIHAS, as assessed live by a blinded evaluator. Responders were defined as subjects who achieved greater than or equal to (\>=) 1 grade improvement on both IOHs on the MIHAS. MIHAS (to assess infraorbital hollow) was a 5-point scale ranging as: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (extreme). A higher score indicated extreme signs of hollowing. This analysis was done using multiple imputation method to impute missing MIHAS scores. Percentage of subjects with response at Week 8 and corresponding confidence intervals were average values obtained from the multiple imputation approach.

Time frame: Week 8

Secondary Outcomes

Percentage of Subjects With Global Aesthetic Improvement Scale (GAIS) Score at Week 8, as Assessed by the Treating Investigator

The GAIS is a 7-point scale ranging as +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the investigator. An improvement on the GAIS was classified as "improved", "much improved", or "very much improved.

Time frame: Week 8

Percentage of Subjects With GAIS Score at Week 8, as Assessed by the Subject

The GAIS is a 7-point scale ranging as +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the subject. An improvement on the GAIS was classified as "improved", "much improved", or "very much improved.

Time frame: Week 8

Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes at Week 8

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

Data from ClinicalTrials.gov

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