118
Participants
Start Date
December 31, 2006
Primary Completion Date
July 31, 2007
Study Completion Date
December 31, 2008
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.
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.
Dermatology Surgery and Laser Center, White Plains
Total Skin and Beauty Dermatology Center, Birmingham
William Coleman, III, MD, Metairie
Skin Care & Laser Physicians of Beverly Hills, Los Angeles
Maas Clinic, San Francisco
Savin Dermatology, New Haven
Merz North America, Inc.
INDUSTRY