A multicenter, open-label, prospective study of cannula injection of small particle hyaluronic acid plus lidocaine for lip augmentation
Mark Nestor, MD, PhD; Miles Graivier, MD, FACS; Raj Chopra, MD, FACS; Sabrina Fabi, MD, FAAD, FAACS; Patricia Meuse, PhD; Jay Mashburn, PhD
Background: The use of blunt-tipped microcannulas is on the rise in augmenting facial soft tissue with dermal fillers.
Purpose: This study was conducted to assess the safety and effectiveness of Restylane® Silk (Q-Med AB, Uppsala, Sweden), a small particle, hyaluronic acid gel plus lidocaine (SPHAL), in conjunction with a small blunt-tipped cannula (range 25G - 30G) for lip augmentation and correction of perioral rhytids.
Design/Methods: An open-label, non-comparative 12 week prospective study conducted in 4 U.S. centers evaluated the safety and effectiveness of SPHAL in conjunction with a blunt-tipped cannula. Adverse events (AEs) were collected throughout the study. Subjects reported pre-defined, expected post-treatment injection site reactions during the first 2 weeks post-treatment via diary. Effectiveness assessments at 4 and 12 weeks post-treatment included treating investigator- and subject-reported Global Aesthetic Improvement Scale (GAIS) scores and treating investigator-reported evaluations using Medicis Lip Fullness Scale (MLFS).
Results: Sixty subjects, aged >23 years (93% women; 88% Caucasian; mean age, 46.5 years), were enrolled. Mean (SD) total volume injected (ie, both lips and perioral rhytids) was 2.2 (0.6) mL. Of the 27 treatment emergent adverse events (TEAEs) reported, 21 were assessed as related to the product and/or injection procedure - injection site swelling (13.3%), injection site bruising (6.7%), and injection site pain (1.7%). Related events were typically mild and transient in nature (median duration - 5 days). No serious AEs (SAEs) were reported. Following treatment, clinically significant improvement using the GAIS and MLFS was demonstrated in a vast majority of subjects through study end (GAIS improvement at week 12: investigator-reported, 98%; subject-reported, 84%; MLFS improvement at week 12: investigator-reported, 96%).
Conclusion: SPHAL was well tolerated and effective following injection with a blunt-tipped microcannula. No new safety concerns were identified in the study population.