A Randomized, Evaluator-Blinded, Controlled Study Of The Effectiveness and Safety Of Small Particle Hyaluronic Acid Plus Lidocaine (SPHAL) For Lip Augmentation

Friday, April 25, 2014
Fredric S. Brandt, MD, Dermatology Research Institute LLC, Coral Gables, FL, Kenneth Beer, MD FAAD, Associate Clinical Professor, West Palm Beach, FL, Rhoda Narins, MD, Dermatology Surgery and Laser Center, New York, NY, Ava Shamban, MD, Ava T Shamban, MD, Inc, Santa Monica, CA, Mandeep Kaur, MD MS, Executive Director, Scottsdale, AZ, Jeffrey Dover, MD, Skincare Physicians, Massachusetts, MA and Mark Nestor, MD PhD, Director, Center for Cosmetic Enhancement Director, Center for Clinical and Cosmetic Research, Aventura, FL
Goals/Purpose: Voluminous lips are associated with youth and beauty, and are an important aesthetic feature of the lower face. Small Particle Hyaluronic Acid plus Lidocaine (SPHAL) has the same chemical composition as the 20 mg/mL family of injectable hyaluronic acid gels currently approved in the U.S. and differs in that the SPHAL gel particle is smaller.  Thus, it may be ideally suited for lip augmentation. Our objective was to compare the safety and effectiveness of SPHAL versus no treatment for lip augmentation. 

Methods/Technique: Adults (n=221; 18-65 y) scoring 1-2 on the validated Medicis Lip Fullness Scale (MLFS; 1=very thin, 5=very full) for both lips were randomized (3:1) to SPHAL or no treatment. Treatment success was defined as a blind-evaluated MLFS increase ≥1 point at week 8. Secondary effectiveness assessments (lip fullness augmentation and subject satisfaction) included the Global Aesthetic Improvement Scale (GAIS) score at weeks 8, 12, 16, 20, 24 weeks; and 2, 4 weeks after optional 6-month re-treatment/treatment. Safety was assessed throughout the trial (adverse events [AEs], standardized assessment of lip function).

Results/Complications: Overall, significantly more subjects treated with SPHAL for the upper lip (80.2% v 11.9%), lower lip (84.2% v 18.4%) and upper and lower lips combined (76.1% v 11.6%) were treatment successes at Week 8, compared with subjects receiving no treatment (P<.001 for all outcomes). GAIS response rates based on subject and investigator assessments demonstrated significant improvement at week 8 (90.1% and 96.5%, respectively [P<.001]) and week 24 (75.6%, and 83.8%, respectively [P<.001]), for upper and lower lips combined. Treatment emergent AEs (TEAEs) were less likely to occur in control subjects, compared with subjects treated with SPHAL.  Most common anticipated TEAEs in the initial SPHAL treatment group included lip bruising, swelling, and pain, and were mostly mild or moderate in severity. No anticipated device-related AEs or significant changes in lip function were noted; few serious AEs were reported, and all unrelated to treatment. In general, TEAEs were transient in nature and resolved in approximately 15 days or less. 

Conclusion: Treatment with SPHAL was effective and well tolerated for augmentation of lip fullness with improvement evident up to 6 months.

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