Study objective: To establish the safety and efficacy of small-gel particle hyaluronic acid (SGP-HA;Restylane?, Medicis Aesthetics Inc., Scottsdale, AZ) for lip augmentation. Study design: This was a Phase 3, prospect...Study objective: To establish the safety and efficacy of small-gel particle hyaluronic acid (SGP-HA;Restylane?, Medicis Aesthetics Inc., Scottsdale, AZ) for lip augmentation. Study design: This was a Phase 3, prospective, open-label, evaluator-blinded, single-center pilot study of SGP-HA use in lip augmentation. The primary efficacy objectives were to investigate the efficacy of SGP-HA in lip augmentation and to assess subject satisfaction with the procedure 12 weeks after treatment. Secondary efficacy objectives were to validate 3D imaging to measure lip augmentation, identify subject satisfaction at all points in time, and identify the duration of lip augmentation and palpability of SGP-HA in the lips. The primary safety objective was to assess the incidence, duration, and severity of all adverse experiences. Results: All 20 subjects and the treating investigator indicated improvement in the appearance of subjects’ lips at weeks 2, 6, and 12. SGP-HA administered for augmentation was well tolerated. Four (20%) subjects treated with SGP-HA experienced 7 treatment-emergent adverse events (TEAEs). Conclusions: Results of this study show promising efficacy and an absence of safety issues with the use of SGP-HA in lip augmentation.展开更多
文摘Study objective: To establish the safety and efficacy of small-gel particle hyaluronic acid (SGP-HA;Restylane?, Medicis Aesthetics Inc., Scottsdale, AZ) for lip augmentation. Study design: This was a Phase 3, prospective, open-label, evaluator-blinded, single-center pilot study of SGP-HA use in lip augmentation. The primary efficacy objectives were to investigate the efficacy of SGP-HA in lip augmentation and to assess subject satisfaction with the procedure 12 weeks after treatment. Secondary efficacy objectives were to validate 3D imaging to measure lip augmentation, identify subject satisfaction at all points in time, and identify the duration of lip augmentation and palpability of SGP-HA in the lips. The primary safety objective was to assess the incidence, duration, and severity of all adverse experiences. Results: All 20 subjects and the treating investigator indicated improvement in the appearance of subjects’ lips at weeks 2, 6, and 12. SGP-HA administered for augmentation was well tolerated. Four (20%) subjects treated with SGP-HA experienced 7 treatment-emergent adverse events (TEAEs). Conclusions: Results of this study show promising efficacy and an absence of safety issues with the use of SGP-HA in lip augmentation.
