A Multi-Center, Open-Label, Prospective Study of Cannula Injection of Small-Particle Hyaluronic Acid Plus Lidocaine (SPHAL) for Lip Augmentation
January 2018 | Volume 17 | Issue 1 | Original Article | 10 | Copyright © January 2018
Raj Chopra MD FACS,a Miles Graivier MD FACS,b Sabrina Fabi MD FAAD FAACS,c Mark Nestor MD PhD,d Patricia Meuse PhD,e Jay Mashburn PhDf
aDavid Geffen School of Medicine at UCLA, Los Angeles, CA; Facial Plastic and Cosmetic Surgery Medical Corp., Beverly Hills, CA bThe Graivier Center for Plastic Surgery, Roswell, GA cCosmetic Laser Dermatology, San Diego, CA; University of California, San Diego, CA dUniversity of Miami, Miller School of Medicine, Miami, FL; The Center for Clinical and Cosmetic Research, Aventura, FL eGalderma R&D, LCC, Fort Worth, TX fGalderma Laboratories, L.P., Fort Worth, TX
Abstract
BACKGROUND: The use of blunt-tipped microcannulas for injection of hyaluronic acid (HA) filler in the lip and perioral area has gained popularity as they provide important safety-related advantages compared to traditional hypodermic needles. This study was conducted to assess the safety and effectiveness associated with the use of a blunt-tipped microcannula for lip augmentation and correction of perioral rhytids using a small-particle, hyaluronic acid gel plus lidocaine (SPHAL).
METHODS: A multi-center, open-label, prospective, study enrolled 60 subjects. Subjects reported injection-related events (IREs) for 2 weeks posttreatment via diary. Adverse events (AEs) were collected throughout the study. Secondary assessments at 4 and 12 weeks posttreatment included treating investigator- and subject-reported improvement in lip fullness using the Global Aesthetic Improvement Scale (GAIS) and investigator-assessed improvement in lip fullness using the Medicis Lip Fullness Scale (MLFS).
RESULTS: Sixty subjects were enrolled and treated with a mean total volume (ie, both lips and optional perioral rhytids) of 2.2 mL. Treatment-emergent adverse events (TEAEs) reported and assessed as related to the product and/or injection procedure included injection site swelling (13.3%), injection site bruising (6.7%), and injection site pain (1.7%). These were typically mild and transient in nature. No serious AEs (SAEs) were reported. Following treatment, clinically significant improvement using the GAIS and MLFS was demonstrated throughout the study (GAIS improvement at week 12 for both lips: investigator-reported, 98.0%; subject-reported, 84.3%; MLFS improvement at week 12: investigator-reported, 96.1%).
CONCLUSION: SPHAL was well tolerated and effective following injection with a blunt-tipped microcannula. No unanticipated safety concerns were identified in the study population.
J Drugs Dermatol. 2018;17(1):10-16.
INTRODUCTION
The use of hyaluronic acid (HA)-based dermal fillers for lip augmentation is among the most frequently-performed minimally invasive cosmetic procedures in the U.S.1 The corrective needs of a patient can range from subtle enhancement of an already adequate shape and volume to a more comprehensive recontouring, including correction of perioral rhytides.2,3 The lip and perioral region are densely vascularized areas and are vulnerable to transient injection-related events (IREs), such as swelling and bruising.4 In addition, the relatively large size and superficial location of the labial arteries of the lips as well as the close location of the angular branch of the facial artery to the corner of the mouth also increase the risk of more serious IREs: vascular occlusion and embolization.5 The use of smaller needles typically associated with lip filler injections are more likely to penetrate the vessel as opposed to side-cut them with a larger bore needle. While rare, the insertion site of small-bore sharp needles at or near the commissure of the lip or into the body of the lip has been associated with more serious adverse events of vascular occlusion and embolization leading to tissue loss along the lip and angular vessel distributions.6 The use of flexible blunt-tipped microcannulas to assist with administration of filler in the lip mucosa and perioral area is gaining acceptance by many practitioners as it has several important safety-related advantages compared to a hypodermic needle. The primary advantage provided by using the microcannula is that it reduces patient discomfort associated with IREs including pain, swelling, redness, and incidence of hematoma, compared to hypodermic needle injections.7-10 Use of
