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

NACompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

August 31, 2020

Primary Completion Date

April 8, 2021

Study Completion Date

June 21, 2022

Conditions
Volume Loss in the Infraorbital Hollow Area
Interventions
DEVICE

Belotero Balance (+) Lidocaine, needle

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

DEVICE

Belotero Balance (+) Lidocaine, cannula

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

DEVICE

Untreated-control / delayed-treatment, needle

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

DEVICE

Untreated-control / delayed-treatment, cannulas

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

Trial Locations (9)

10549

The Center for Dermatology, Cosmetic & Laser Surgery, Merz Investigational Site #0010442, Mount Kisco

11229

Project Glammers, Merz Investigational Site #0010443, Brooklyn

11795

Mariwalla Dermatology, Merz Investigational Site #0010445, West Islip

28078

HKB Surgeons, Merz Investigational Site #0010447, Huntersville

30342

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

37203

Nashville Centre for Laser & Facial Surgery, Merz Investigational Site #0010353, Nashville

92075

Art of Skin MD, Merz Investigational Site #0010444, Solana Beach

92083

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

00917

Jose Raul Montes Eyes and Facial Rejuvenation, Merz Investigational Site #0010436, San Juan

All Listed Sponsors
lead

Merz North America, Inc.

INDUSTRY

NCT04594239 - Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow | Biotech Hunter | Biotech Hunter