Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®.

PHASE3CompletedINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

July 31, 2007

Study Completion Date

December 31, 2008

Conditions
Facial Wrinkles
Interventions
DEVICE

Belotero

Belotero, injectable hyaluronic acid gel device, implanted into the nasolabial fold in the Treatment Phase of the study (multiple injections of 0.1 to 0.2 mL, up to a maximum of 3 mL over 2 treatment sessions). Dose was based on the severity of the wrinkle, with a maximum dose to achieve 100% correction to be administered.

DEVICE

Zyplast

Zyplast Collagen Implant, an injectable dermal collagen device, implanted into the nasolabial fold in the Treatment Phase of the study (average injection of 1.0 mL). Dose was based on the severity of the wrinkle, with a maximum dose to achieve 100% correction to be administered. Zyplast was obtained by each site from commercially available supplies.

Trial Locations (6)

10604

Dermatology Surgery and Laser Center, White Plains

35205

Total Skin and Beauty Dermatology Center, Birmingham

70006

William Coleman, III, MD, Metairie

90069

Skin Care & Laser Physicians of Beverly Hills, Los Angeles

94115

Maas Clinic, San Francisco

06511

Savin Dermatology, New Haven

All Listed Sponsors
lead

Merz North America, Inc.

INDUSTRY

NCT00876265 - Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®. | Biotech Hunter | Biotech Hunter