Safety, Efficacy, and Patient Satisfaction With OnabotulinumtoxinA for the Treatment of Upper Facial Lines in Japanese Subjects

• Published in: Dermatologic surgery Vol. 46; no. 4; p. 483
• Main Authors: Kawashima, Makoto, Harii, Kiyonori, Horiuchi, Yuki, Seidman, Emily, Lei, Xiaofang, Hopfinger, René, Lee, Elisabeth
• Format: Journal Article
• Language: English
• Published: United States 01.04.2020
• Subjects: Adult; Botulinum Toxins, Type A - administration & dosage; Botulinum Toxins, Type A - adverse effects; Cosmetic Techniques - adverse effects; Double-Blind Method; Eye; Female; Forehead; Humans; Japan; Male; Middle Aged; Neuromuscular Agents - administration & dosage; Neuromuscular Agents - adverse effects; Patient Reported Outcome Measures; Patient Satisfaction; Rejuvenation; Skin Aging - drug effects; Treatment Outcome; Japan
• ISSN: 1524-4725
• DOI: 10.1097/DSS.0000000000002143

OnabotulinumtoxinA treatment for glabellar lines (GL) or crow's-feet lines (CFL) was previously studied in Japanese subjects. To assess safety and efficacy of repeated onabotulinumtoxinA for moderate to severe GL and CFL in Japanese subjects. This 13-month, double-blind, Phase 3 study randomized subjects to onabotulinumtoxinA 44 U (n = 48) or 32 U (n = 53) for CFL and GL for up to 5 treatments (CFL: 24 U or 12 U; GL: 20 U). Outcomes included proportion of subjects achieving none/mild severity at maximum smile (CFL) and maximum frown (GL), using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A); proportion of ≥1-grade improvement responders at maximum smile and at rest (CFL), at maximum frown and at rest (GL); subject-reported outcomes; and safety. Most subjects were responders (none/mild on FWS-A; CFL: 89.6% [44 U], 84.9% [32 U]; GL: 93.8% [44 U], 98.1% [32 U]) on Day 30. Across treatment groups, responder rates were consistent over time and treatments. Most subjects were satisfied with improved CFL appearance and with treatment. Incidence of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs across groups was similar. All TEAEs but one (peritonitis) were mild or moderate. Repeated onabotulinumtoxinA was effective and well tolerated.