Clinical trial NCT04594239: Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow
Official title: Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Volume Loss in the Infraorbital Hollow Area
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-20
Enrollment: 150
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Responder Rate Based on Merz Infraorbital Hollow Assessment Scale (MIHAS) at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Subjects With Global Aesthetic Improvement Scale (GAIS) Score at Week 8, as Assessed by the Treating Investigator
timeFrame: Week 8
measure: Percentage of Subjects With GAIS Score at Week 8, as Assessed by the Subject
timeFrame: Week 8
measure: Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes at Week 8
timeFrame: Baseline, Week 8
measure: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Related to BBL
timeFrame: BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks
measure: Number of Subjects With Treatment-Emergent Serious Adverse Events (TESAEs) Related to BBL
timeFrame: BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks
Other outcomes:
Locations:
city: Solana Beach
country: United States
facility: Art of Skin MD, Merz Investigational Site #0010444
state: California
city: Vista
country: United States
facility: Moradi MD Face Beautiful Inc., Merz Investigational Site #0010358
state: California
city: Atlanta
country: United States
facility: MetroDerm / Atlanta Center for Clinical Research, Merz Investigational Site #0010446
state: Georgia
city: Brooklyn
country: United States
facility: Project Glammers, Merz Investigational Site #0010443
state: New York
city: Mount Kisco
country: United States
facility: The Center for Dermatology, Cosmetic & Laser Surgery, Merz Investigational Site #0010442
state: New York
city: West Islip
country: United States
facility: Mariwalla Dermatology, Merz Investigational Site #0010445
state: New York
city: Huntersville
country: United States
facility: HKB Surgeons, Merz Investigational Site #0010447
state: North Carolina
city: Nashville
country: United States
facility: Nashville Centre for Laser & Facial Surgery, Merz Investigational Site #0010353
state: Tennessee
city: San Juan
country: Puerto Rico
facility: Jose Raul Montes Eyes and Facial Rejuvenation, Merz Investigational Site #0010436
Study officials:
affiliation: Merz North America, Inc.
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: