Patricia Ogilvie1, Alexander Z Rivkin2, Steven Dayan3, Steven G Yoelin4, Barry M Weichman5, Julie K Garcia6. 1. Skin Concept, Munich, Germany. 2. David Geffen School of Medicine, UCLA, Los Angeles, California. 3. DeNova Research, Chicago, Illinois. 4. Medical Associates Inc., Newport Beach, California. 5. Peloton Advantage, Parsippany, New Jersey. 6. Allergan plc, Irvine, California.
Abstract
BACKGROUND: Patient-reported outcomes are important measures of treatment benefit in facial aesthetic medicine. OBJECTIVE: Evaluate prespecified subject-reported satisfaction and impact outcomes with onabotulinumtoxinA treatment of forehead lines (FHL) and glabellar lines (GL). METHODS: The study randomized (3:1) 391 adults with moderate to severe FHL and GL to onabotulinumtoxinA (FHL, 20 U; GL, 20 U) orplacebo in double-blind period 1 (days 0-180); subjects could receive up to 2 additional onabotulinumtoxinA treatments in open-label period 2. Patient-reported outcomes were assessed using the validated Facial Line Satisfaction Questionnaire (FLSQ) and the 11-item Facial Line Outcomes (FLO-11) Questionnaire. RESULTS: The proportion of subjects mostly or very satisfied with treatment was significantly greater with onabotulinumtoxinA than with placebo (90.3% vs 1.0%; p < .0001). Responder rates on FLSQ Impact Domain (73.9% vs 18.9%), FLO-11 Item 1 (85.4% vs 3.6%), Item 4 (77.2% vs 11.2%), Item 5 (83.5% vs 7.8%), and total score (86.0% vs 6.9%) were significantly greater with onabotulinumtoxinA than with placebo on Day 30 (p < .0001). Responder rates favoring onabotulinumtoxinA in Period 1 were generally maintained with repeated treatment during Period 2. CONCLUSION: Subjects were highly satisfied with onabotulinumtoxinA treatment and reported significant improvements in appearance-related psychological and emotional impacts of their facial lines.
RCT Entities:
BACKGROUND:Patient-reported outcomes are important measures of treatment benefit in facial aesthetic medicine. OBJECTIVE: Evaluate prespecified subject-reported satisfaction and impact outcomes with onabotulinumtoxinA treatment of forehead lines (FHL) and glabellar lines (GL). METHODS: The study randomized (3:1) 391 adults with moderate to severe FHL and GL to onabotulinumtoxinA (FHL, 20 U; GL, 20 U) or placebo in double-blind period 1 (days 0-180); subjects could receive up to 2 additional onabotulinumtoxinA treatments in open-label period 2. Patient-reported outcomes were assessed using the validated Facial Line Satisfaction Questionnaire (FLSQ) and the 11-item Facial Line Outcomes (FLO-11) Questionnaire. RESULTS: The proportion of subjects mostly or very satisfied with treatment was significantly greater with onabotulinumtoxinA than with placebo (90.3% vs 1.0%; p < .0001). Responder rates on FLSQ Impact Domain (73.9% vs 18.9%), FLO-11 Item 1 (85.4% vs 3.6%), Item 4 (77.2% vs 11.2%), Item 5 (83.5% vs 7.8%), and total score (86.0% vs 6.9%) were significantly greater with onabotulinumtoxinA than with placebo on Day 30 (p < .0001). Responder rates favoring onabotulinumtoxinA in Period 1 were generally maintained with repeated treatment during Period 2. CONCLUSION: Subjects were highly satisfied with onabotulinumtoxinA treatment and reported significant improvements in appearance-related psychological and emotional impacts of their facial lines.
Authors: Cristina Pires Camargo; Jun Xia; Caroline S Costa; Rolf Gemperli; Maria Dc Tatini; Max K Bulsara; Rachel Riera Journal: Cochrane Database Syst Rev Date: 2021-07-05