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Multicenter Study Clinical Trial
An open-label, pilot study to assess the effectiveness and safety of hyaluronic acid gel in the restoration of soft tissue fullness of the lips.
- Nowell Solish and Arthur Swift.
- The University of Toronto, Toronto, Ontario, Canada. n.solish@utoronto.ca
- J Drugs Dermatol. 2011 Feb 1; 10 (2): 145-9.
BackgroundThere have been few systematic investigations of the effectiveness, safety and tolerability of aesthetic lip augmentation using hyaluronic acid (HA) fillers.ObjectivesEvaluate the effectiveness of small gel particle hyaluronic acid filler (Restylane Injectable Gel [SGP-HA]; Medicis Aesthetics Inc., Scottsdale, AZ) in lip augmentation using the Medicis Lip Fullness Scale (MLFS). Assess subjective improvement in lip appearance using the Global Aesthetic Improvement Scale (GAIS).Patients, Materials And MethodsInvestigators treated 21 adults. The primary efficacy endpoint was an increase in lip fullness at least one grade on MLFS at eight weeks post-treatment. Adverse events were reported using patient diaries.ResultsSixteen of 18 evaluable subjects (89%) had an improvement at least one grade on MLFS in both lips. MLFS and GAIS scores were consistent, suggesting clinically significant aesthetic improvement. Adverse effects were transient and mostly mild to moderate in severity.ConclusionLip augmentation with SGP-HA was well tolerated and resulted in clinically meaningful increases in lip fullness.
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