Patient-reported outcomes with botulinum toxin type A treatment of glabellar rhytids: a double-blind, randomized, placebo-controlled study.

Author: Fagien S, Cox SE, Finn JC, Werschler WP, Kowalski JW

Author affiliation: Private Practice Aesthetic Oculoplastic Surgery, Boca Raton, Florida 33431, USA. sfagien@aol.com

Publication date & source: 2007.01, Dermatol Surg., 33(1 Spec No.):S2-9.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: Global patient-reported outcomes do not evaluate specific aspects of treatment that are important to patients. OBJECTIVE: The objective was to evaluate self-perception of age and specific outcomes that are important to patients receiving botulinum toxin type A or placebo for moderate to severe glabellar lines (using the Facial Line Outcomes Questionnaire to assess how much facial lines bother them, make them look older, detract from their facial appearance, prevent a smooth facial appearance, and make them look tired, stressed, or angry). METHODS AND MATERIALS: In the double-blind phase of this 12-week study, 70 patients were randomly assigned to treatment with 20 U botulinum toxin type A (BOTOX Cosmetic) or placebo. At Week 4, those still with moderate or severe glabellar lines were offered open-label 20 U botulinum toxin type A. RESULTS: Median glabellar line severity was significantly lower after botulinum toxin treatment than after placebo. Compared with placebo, botulinum toxin also resulted in significantly superior patient assessments and a greater proportion of patients considering they looked younger than their current age. CONCLUSIONS: Botulinum toxin type A can achieve specific goals of treatment that are important to patients and help them feel that they look younger than their current age.

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