A Single-Center Dose-Comparison Study of Botulinum Neurotoxin Type A in Females With Upper Facial Rhytids: Assessing Patients’ Perception of TreatmentOutcomes

October 2009 | Volume 8 | Issue 10 | Original Article | 924 | Copyright © October 2009

Alastair Carruthers MD and Jean Carruthers MD

Abstract
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.