A double-blind, clinical evaluation of facial augmentation treatments: a comparison of PRI 1, PRI 2, Zyplast® and Perlane®

Summary 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.