Safety, Efficacy, and Patient Satisfaction With OnabotulinumtoxinA for the Treatment of Upper Facial Lines in Japanese Subjects
| Autor: | Kiyonori Harii, Emily Seidman, Xiaofang Lei, René Hopfinger, Elisabeth Lee, Yuki Horiuchi, Makoto Kawashima |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Moderate to severe
Adult Male medicine.medical_specialty Treatment outcome MEDLINE Dermatology Cosmetic Techniques Eye law.invention 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Patient satisfaction Randomized controlled trial Double-Blind Method Japan law medicine Humans Rejuvenation Forehead Patient Reported Outcome Measures Botulinum Toxins Type A business.industry General Medicine Middle Aged Skin Aging Clinical trial medicine.anatomical_structure Treatment Outcome Multicenter study Neuromuscular Agents Patient Satisfaction 030220 oncology & carcinogenesis Physical therapy Surgery Female business |
| Zdroj: | Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]. 46(4) |
| ISSN: | 1524-4725 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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