A single-center dose-comparison study of botulinum neurotoxin type A in females with upper facial rhytids: assessing patients' perception of treatment outcomes.

摘要

BACKGROUND: Few studies evaluate patient-reported outcomes (PROs). OBJECTIVES: To assess the PROs of treatment with botulinum neurotoxin type A (BoNTA) in upper facial lines; to evaluate two new PRO instruments. METHODS: Prospective, randomized, double-blind study of 32 U, 64 U, or 96 U BoNTA divided among 16 sites. Measurements included the Facial Line Outcomes (FLO-11) Questionnaire version 1.0 and the Self-Perception of Age (SPA) measure version 2.0. RESULTS: Sixty females, mean age 42 +/- 8.7 years, were enrolled. Significant improvements (P<0.01) in mean FLO-11 scores occurred by week 2 for all groups and remained significant through week 16 for all groups except the 32-U group. Approximately 45-60% of the patients reported looking younger by a mean of 3.6-5.8 years. Conclusion: BoNTA treatment resulted in desired relaxed and younger appearance, as measured by the FLO-11 Questionnaire and the SPA measure.