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

Not Applicable

Completed

Conditions: Volume Loss in the Infraorbital Hollow Area

Interventions: Device: Untreated-control / delayed-treatment, cannulas
Device: Untreated-control / delayed-treatment, needle
Device: Belotero Balance (+) Lidocaine, needle
Device: Belotero Balance (+) Lidocaine, cannula

Registration Number: NCT04594239

Lead Sponsor: Merz North America, Inc.

Brief Summary: * 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 150

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Untreated-control / delayed-treatment, cannula	Untreated-control / delayed-treatment, cannulas	-
Untreated-control / delayed-treatment, needle	Untreated-control / delayed-treatment, needle	-
Treatment, needle	Belotero Balance (+) Lidocaine, needle	-
Treatment, cannula	Belotero Balance (+) Lidocaine, cannula	-

Primary Outcome Measures

Name	Time	Method
Responder Rate Based on Merz Infraorbital Hollow Assessment Scale (MIHAS) at Week 8	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With Global Aesthetic Improvement Scale (GAIS) Score at Week 8, as Assessed by the Treating Investigator	Week 8	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.
Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes at Week 8	Baseline, 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).
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Related to BBL	BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks	TEAEs are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment. A TEAE was considered to be "related" if a causal relationship between BBL and the TEAE is at least reasonably possible.
Percentage of Subjects With GAIS Score at Week 8, as Assessed by the Subject	Week 8	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.
Number of Subjects With Treatment-Emergent Serious Adverse Events (TESAEs) Related to BBL	BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks	TESAEs included TEAEs that resulted in death, required either inpatient hospitalization or the prolongation of hospitalization, were life-threatening, resulted in a persistent or significant disability/incapacity or resulted in a congenital anomaly/birth defect. A TESAE was considered to be "related" if a causal relationship between BBL and the TESAE is at least reasonably possible.

Trial Locations

Locations (9): MetroDerm / Atlanta Center for Clinical Research, Merz Investigational Site #0010446
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Atlanta, Georgia, United States
Project Glammers, Merz Investigational Site #0010443
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Brooklyn, New York, United States
Nashville Centre for Laser & Facial Surgery, Merz Investigational Site #0010353
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Nashville, Tennessee, United States
Jose Raul Montes Eyes and Facial Rejuvenation, Merz Investigational Site #0010436
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San Juan, Puerto Rico
Art of Skin MD, Merz Investigational Site #0010444
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Solana Beach, California, United States
Moradi MD Face Beautiful Inc., Merz Investigational Site #0010358
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Vista, California, United States
Mariwalla Dermatology, Merz Investigational Site #0010445
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West Islip, New York, United States
The Center for Dermatology, Cosmetic & Laser Surgery, Merz Investigational Site #0010442
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Mount Kisco, New York, United States
HKB Surgeons, Merz Investigational Site #0010447
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Huntersville, North Carolina, United States