A double-blind, clinical evaluation of facial augmentation treatments: a comparison of PRI 1, PRI 2, Zyplast and Perlane.
BACKGROUND
Facial wrinkles are caused by weakening of the sub-dermal collagen support layer. Dermal fillers can be used to treat wrinkles, and this double-blind, randomised, single-centre study compared four fillers: PRI 1, PRI 2 (both porcine collagen), Zyplast (purified bovine collagen) and Perlane (cross-linked hyaluronic acid gel).


METHODS
79 females (aged 25-55 years) with wrinkles in the upper lip line border were randomised to PRI 1 (19 patients), PRI 2 (19 patients), Perlane (23 patients), Zyplast (18 patients). Patients were assessed at 1 week and 1, 3, 6, 9 and 12 months using 2D images and by mathematically derived facial volume changes using 3D stereophotogrammetry.


RESULTS
All treatments produced larger, less wrinkled, more prominent lips. PRI 1, PRI 2 and Zyplast showed similar lip volume gains, with Perlane showing the greatest upper lip volume increase. All treatments were comparable for rates of decrease in upper lip volume post-treatment, however, Perlane maintained higher lip volume gains at each time point. Investigators indicated PRI 1 was significantly easier to deliver than Zyplast. Patient satisfaction scores were similar, though there was a trend towards greater dissatisfaction for PRI 1 and PRI 2 at month 9 (p=0.052). Treatment was well-tolerated, with 'cold sore' being the most common adverse event.


CONCLUSIONS
Results showed that PRI 1 and PRI 2 were comparable to Perlane and Zyplast as dermal fillers. Further rigorous studies are required to establish the performance of dermal fillers and patient acceptability. We propose the utilisation of stereophotogrammetry for assessment of volume changes.
Downie
Jeff
J
Department of Oral and Maxillofacial Surgery, Southern General Hospital, 1345 Govan Road, Glasgow G51 4TF, UK.
Mao
Zhili
Z
Rachel Lo
Tsz-Wai
TW
Barry
Sarah
S
Bock
Mitchum
M
Siebert
J Paul
JP
Bowman
Adrian
A
Ayoub
Ashraf
A
D000328:Adult; D001672:Biocompatible Materials / Q000627:therapeutic use; D003094:Collagen / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use; D021621:Imaging, Three-Dimensional / Q000379:methods; D008046:Lip / Q000473:pathology / Q000601:surgery*; D008875:Middle Aged; D017060:Patient Satisfaction; D010780:Photogrammetry / Q000379:methods; D019736:Prostheses and Implants; D015361:Rhytidoplasty / Q000009:adverse effects / Q000379:methods*; D015595:Skin Aging; D016896:Treatment Outcome
D001672:Biocompatible Materials; C502935:Perlane; C422414:Permacol; C048470:glutaraldehyde-cross-linked collagen; D006820:Hyaluronic Acid; D003094:Collagen