ArteFill: a long-lasting injectable wrinkle filler material--summary of the U.S. Food and Drug Administration trials and a progress report on 4- to 5-year outcomes.
ArteFill, the successor product to Artecoll, is an injectable wrinkle filler composed of polymethylmethacrylate microspheres and bovine collagen, which offers long-lasting and probably permanent augmentation of wrinkles and skin contour deformities. The pivotal U.S. Food and Drug Administration study consisted of 251 subjects at eight centers in the United States who received injections of ArteFill or bovine collagen dermal filler (control) in 1334 wrinkles of the glabella, nasolabial folds, radial upper lip lines, and corners of the mouth. The efficacy data generated by masked observers using a photographic Facial Fold Assessment Scale demonstrated a significant improvement with ArteFill compared with collagen at 6 months (p < 0.001) in the nasolabial folds. In the ArteFill group, 12-month follow-up was obtained for 111 subjects (86.7 percent) and showed persistence of significant wrinkle correction. A subgroup of 69 patients who received ArteFill were recalled 4 to 5 years later. Five patients reported six late adverse events that occurred from 2 to 5 years after the initial injection; four of the adverse events were mild cases of lumpiness and two were severe. The total number of late adverse events was six of 272 (2.2 percent) wrinkles injected. Among the 272 wrinkles evaluated at 5 years, two events (0.7 percent) in one patient were rated as severe (a nodular, minimally inflammatory to noninflammatory reaction in both nasolabial folds). Investigator Facial Fold Assessment ratings at 4 to 5 years were improved from baseline by 1.67 points (p < 0.001).
Cohen
Steven R
SR
Division of Plastic Surgery, Department of Dermatology, University of California, USA. scohen@facesplus.com
Berner
Carl F
CF
Busso
Mariano
M
Gleason
Mathew C
MC
Hamilton
Douglas
D
Holmes
Ralph E
RE
Romano
James J
JJ
Rullan
Peter P
PP
Thaler
Millard P
MP
Ubogy
Zeena
Z
Vecchione
Thomas R
TR
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001672:Biocompatible Materials / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002921:Cicatrix / Q000628:therapy*; D003094:Collagen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003357:Cosmetic Techniques / Q000009:adverse effects; D004890:Erythema / Q000209:etiology; D005145:Face; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008422:Materials Testing; D008863:Microspheres; D008875:Middle Aged; D017060:Patient Satisfaction; D019904:Polymethyl Methacrylate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012060:Rejuvenation; D012720:Severity of Illness Index; D016037:Single-Blind Method; D015595:Skin Aging; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
D001672:Biocompatible Materials; D003094:Collagen; D019904:Polymethyl Methacrylate