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

Downie, Jeff; Mao, Zhili; Rachel Lo, Tsz-Wai; Barry, Sarah; Bock, Mitchum; Siebert, J. Paul; Bowman, Adrian; Ayoub, Ashraf

doi:10.1016/j.bjps.2008.06.056

« Previous Next »Journal of Plastic, Reconstructive & Aesthetic Surgery
Volume 62, Issue 12 , Pages 1636-1643, December 2009

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

Jeff Downie
- Department of Oral and Maxillofacial Surgery, Southern General Hospital, 1345 Govan Road, Glasgow G51 4TF, UK
Zhili Mao
- Department of Computing Science, University of Glasgow, Glasgow G12 8QQ, UK
Tsz-Wai Rachel Lo
- Department of Computing Science, University of Glasgow, Glasgow G12 8QQ, UK
Sarah Barry
- Department of Statistics, University of Glasgow, Glasgow G12 8QQ, UK
Mitchum Bock
- Department of Statistics, University of Glasgow, Glasgow G12 8QQ, UK
J. Paul Siebert
- Department of Computing Science, University of Glasgow, Glasgow G12 8QQ, UK
Adrian Bowman
- Department of Computing Science, University of Glasgow, Glasgow G12 8QQ, UK
Ashraf Ayoub
- Glasgow Dental Hospital and School, BACS Section, Faculty of Medicine, Glasgow University, 378 Sauchiehall Street, Glasgow G2 3JZ, UK
- Corresponding author. Tel.: +44 141 211 9604; fax: +44 141 211 9601.

Received 5 September 2007; accepted 9 June 2008. published online 05 November 2008.

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.

Keywords: Dermal fillers, Collagen, Lip, Ageing, Stereophotogrammetry, 3D soft tissue analysis