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

Published:November 05, 2008DOI:https://doi.org/10.1016/j.bjps.2008.06.056

      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

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      References

        • Ayoub A.F.
        • Siebert P.
        • Moos K.F.
        • et al.
        A vision-based three-dimensional capture system for maxillofacial assessment and surgical planning.
        Br J Oral Maxillofac Surg. 1998; 36: 353-357
        • Ayoub A.
        • Garrahy A.
        • Hood C.
        • et al.
        Validation of a vision-based, three-dimensional facial imaging system.
        Cleft Palate Craniofac J. 2003; 40: 523-529
        • Hajeer M.Y.
        • Mao Z.
        • Millett D.T.
        • et al.
        A new three-dimensional method of assessing facial volumetric changes following orthognathic treatment.
        Cleft Palate Craniofac J. 2005; 42: 113-120
        • Pinheiro J.
        • Bates D.
        Mixed-effects models in S and S-PLUS. Statistics and Computing. vol. 172. Springer-Verlag, New York2000
        • Klein A.W.
        Skin filling. Collagen and other injectables of the skin.
        Dermatol Clin. 2001; 19: 491-508
        • Ferrario V.F.
        • Sforzac C.
        • Serrao G.
        A three-dimensional quantitative analysis of lips in normal young adults.
        Cleft Palate Craniofac J. 2000; 37: 48-54
        • Wall S.J.
        • Adamson P.A.
        Augmentation, enhancement, and implantation procedures for the lips.
        Otolaryngol Clin North Am. 2002; 35: 87-102
        • Bisson M.
        • Grobbellaar A.
        The aesthetic properties of lips: A comparison of models and non models.
        Angle Orthod. 2003; 74: 162-166
        • Klein A.W.
        • Elson M.L.
        The history of substances for soft tissue augmentation.
        Dermatol Surg. 2000; 26: 1096-1105
        • Pollack S.V.
        Some new injectable dermal filler materials: hylaform, restylane, and artecoll.
        J Cutan Med Surg. 1999; 3: 27-35
        • Troilius C.
        Soft tissue fillers: what options are available today?.
        Aesth Surg J. 1999; 19: 505-507
        • Olenius M.
        The first clinical study using a new biodegradeable implant for the treatment of lips, wrinkles and folds.
        Aesthetic Plast Surg. 1998; 22: 97-101
        • de Cassia Novaes W.
        • Berg A.
        Experiences with a new nonbiodegradable hydrogel (Aquamid): a pilot study.
        Aesthetic Plast Surg. 2003; 27: 376-380
        • Duranti F.
        • Salti G.
        • Bovani B.
        • et al.
        Injectable hyaluronic acid gel for soft tissue augmentation. A clinical and histological study.
        Dermatol Surg. 1998; 24: 1317-1325
        • Micheels P.
        Human anti-hyaluronic acid antibodies: is it possible?.
        Dermatol Surg. 2001; 27: 185-191
        • Lemperle G.
        • Holmes R.E.
        • Cohen S.R.
        • et al.
        A classification of facial wrinkles.
        Plast Reconstr Surg. 2001; 108: 1735-1750
        • Fitzpatrick R.E.
        • Goldman M.P.
        • Satur N.M.
        • et al.
        Pulsed carbon dioxide laser resurfacing of photo-aged facial skin.
        Arch Dermatol. 1996; 132: 395-402
        • Glogau R.G.
        Aesthetic and anatomical analysis of the aging skin.
        Semin Cutan Med Surg. 1996; 15: 134-138
        • Ashinoff R.
        Overview: soft tissue augmentation.
        Clin Plast Surg. 2000; 27: 479-487