A single-center dose-comparison study of botulinum neurotoxin type A in females with upper facial rhytids: assessing patients' perception of treatment outcomes.
BACKGROUND
Few studies evaluate patient-reported outcomes (PROs).


OBJECTIVE
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.


CONCLUSIONS
BoNTA treatment resulted in desired relaxed and younger appearance, as measured by the FLO-11 Questionnaire and the SPA measure.
Carruthers
Alastair
A
University of British Columbia, Department of Dermatology and Skin Science, Vancouver, BC, Canada. alastair@carruthers.net
Carruthers
Jean
J
D000328:Adult; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005145:Face; D005260:Female; D006801:Humans; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage*; D017060:Patient Satisfaction; D010865:Pilot Projects; D011446:Prospective Studies; D015595:Skin Aging; D013997:Time Factors
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A