Abstract: Patient Satisfaction with Onabotulinumtoxina Treatment of Glabellar and Lateral Canthal Lines Evaluated Using the Flsq: A New Patient-Reported Outcome Measure (Plastic Surgery 2014)

Saturday, October 11, 2014: 2:25 PM

Jason Rivers, MD, FRCPC, DABD, FAAD , Department of Dermatology and Skin Science, University of British Columbia, Vancouver, BC, Canada

Vince Bertucci, MD, FRCPC , Division of Dermatology, University of Toronto, Toronto, ON, Canada

Channy Muhn, MD, FRCPC , Division of Dermatology, McMaster University, Hamilton, ON, Canada

Nathan Rosen, MD, FRCPC , Division of Dermatology, McMaster University, Hamilton, ON, Canada

Kevin Smith, MD, FRCPC , Niagara Falls Dermatology & Skin Care Centre, Niagara Falls, ON, Canada

Nowell Solish, MD, FRCPC , Division of Dermatology, Women’s College Hospital, Toronto, ON, Canada

Sarah Darmody, BS , Allergan, Inc., Irvine, CA

Selena Daniels, PharmD, MS , Allergan, Inc., Irvine, CA

Conor Gallagher, PhD , Allergan, Inc., Irvine, CA

Presentation PDF file

E-Poster

Objective: Determine subject satisfaction with onabotulinumtoxinA treatment of glabellar lines (GL) and lateral canthal lines (LCL) using the Facial Line Satisfaction Questionnaire (FLSQ), a recently developed and validated patient-reported outcome measure.

Materials and Methods: This randomized, double-blind, placebo-controlled, multicenter study enrolled subjects with moderate or severe GL and with LCL. Subjects received a total of 44 U of onabotulinumtoxinA (20 U for GL; 24 U for LCL) or placebo. Assessments were performed at 30, 60, 90, and 120 days after treatment. The FLSQ Follow-up Version is a 13-item instrument with 5 domains: treatment satisfaction, treatment impact, treatment expectations, recommending treatment, and continuing treatment. A validated stand-alone question from FLSQ (#5) was used to assess overall satisfaction with GL and LCL. Additional assessments included severity of GL and LCL using the Facial Wrinkle Scale with photonumeric guide (FWS), and investigator- and subject-evaluated improvement in facial lines on the Global Aesthetic Improvement Scale (GAIS).

Results: Of 125 subjects enrolled in the study, 117 (mean age, 46.7 years; females, 83.6%) met the criteria for the per-protocol analysis. Most subjects (82.0%) receiving onabotulinumtoxinA were “satisfied”/“very satisfied” with treatment effect on GL and LCL at the primary time point of day 60 versus placebo (0%; P<.001). Similar results were seen at all time points (Figure). Treatment exceeded or met expectations in at least 85% of subjects at all time points. On the FWS, 83.6% and 86.9% of subjects achieved none or mild for GL and at least a 1-grade improvement for LCL at day 30 versus placebo (1.8% and 8.9%, respectively). Most subjects were “improved”/“much improved” on the GAIS at day 60 as assessed by the investigator and subject (86.9% and 82.0%, respectively). Adverse events were infrequent and typical of those seen in similar clinical trials, with 6 subjects experiencing 7 onabotulinumtoxinA-related adverse events (one moderate [headache], the rest mild in severity). No subjects experienced ptosis.

Conclusions: High and sustained satisfaction in subjects treated with onabotulinumtoxinA for GL and LCL was achieved. At least 85% of subjects reported that treatment met or exceeded expectations at all time points.

Figure. Subject satisfaction with treatment effect on GL and LCL.

24739 Patient Satisfaction with Onabotulinumtoxina Treatment of Glabellar and Lateral Canthal Lines Evaluated Using the Flsq: A New Patient-Reported Outcome Measure