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Patient Satisfaction and Safety With Aesthetic OnabotulinumtoxinA After At Least 5 Years

A Retrospective Cross-Sectional Analysis of 4,402 Glabellar Treatments

Trindade de Almeida, Ada MD*; Carruthers, Jean MD, FRCSC; Cox, Sue Ellen MD; Goldman, Mitchel P. MD§; Wheeler, Sarah BS; Gallagher, Conor J. PhD

doi: 10.1097/DSS.0000000000000275
Original Article
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BACKGROUND Despite extensive clinical experience with onabotulinumtoxinA, few data exist on patient satisfaction or safety with continuous treatment.

OBJECTIVE This international multicenter study evaluated patient satisfaction and safety with long-term continuous facial aesthetic treatment with onabotulinumtoxinA.

METHODS Retrospective chart review with a cross-sectional design was used to assess onabotulinumtoxinA treatment, including dosing, concomitant facial aesthetic medications and procedures, and adverse events (AEs). Validated Facial Line Satisfaction Questionnaire, Self-Perception of Age measure, and Facial Line Outcomes questionnaire instruments, and a de novo questionnaire were used to determine patient satisfaction.

RESULTS A total of 207 patients consisted of the intent-to-treat population, with 194 in the per protocol analyses. Patients received a total of 4,402 glabellar treatments over a mean of 9.1 years, with a mean dose of 21.6 U per treatment. Overall, 92.3% of patients were mostly or very satisfied. Among the 89.7% of patients who reported looking younger, the mean perceived age was 6.9 years younger. Documented AEs were infrequent, mostly mild in severity, and declined in frequency over time.

LIMITATIONS This population was self-selecting as they chose to continue treatment for 5 or more years to be eligible.

CONCLUSION Continuous treatment with onabotulinumtoxinA for a mean of 9.1 years was associated with very high patient satisfaction.

*Hospital Do Servidor Publico Municipal, Sao Paulo, Brazil;

Carruthers Clinical Research, Vancouver, British Columbia, Canada;

Aesthetic Solutions, Chapel Hill, North Carolina;

§Goldman, Butterwick, Fitzpatrick, Groff and Fabi: Cosmetic Laser Dermatology, San Diego, California;

Allergan, Inc., Irvine, California

Address correspondence and reprint requests to: Ada Trindade de Almeida, MD, Rua Turiaçu, 390 cj, 114, Perdizes, 05005-000, Sao Paulo, Brazil, or e-mail: artrindal@uol.com.br

Supported by Allergan, Inc., Irvine, CA. Writing and editorial assistance was provided to the authors by Peloton Advantage, LLC, Parsippany, NJ, and funded by Allergan Inc., Irvine, CA.

Dr. A. Trindade de Almeida is a consultant for, has received research grants from, and serves as an advisory board member for Allergan, Inc., Irvine, CA. Dr. J. Carruthers is a consultant for, has received research grants from, and serves as an advisory board member for Allergan, Inc., Kythera Biopharmaceuticals, Calabasas, CA, and Merz, Greensboro, NC. Dr. M. P. Goldman is a consultant for and has received research grants from Allergan, Inc. and Merz, and is a speaker for Valeant Pharmaceuticals, Bridgewater, NJ. Dr. S. E. Cox is a consultant for, has received research grants from, and is an advisory board member for Allergan, Inc.; has received research grants from and is a stock shareholder of Kythera Biopharmaceuticals; has received research grants from Lithera, San Diego, CA; is a consultant and speaker for Merz; and is a consultant for and has received research grants from Medicis (Valeant). S. Wheeler and C. J. Gallagher are employees of Allergan, Inc., Irvine, CA.

© 2015 by the American Society for Dermatologic Surgery, Inc. Published by Lippincott Williams & Wilkins
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