OnabotulinumtoxinA (Botox) in the Treatment of Crow’s Feet Lines in Japanese Subjects
| Autor: | Makoto Kawashima, Elisabeth Lee, Nobutaka Furuyama, Xiaofang Lei, Kiyonori Harii, René Hopfinger |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male Moderate to severe medicine.medical_specialty Esthetics Injections Subcutaneous Neurotoxins Kaplan-Meier Estimate Injections Intralesional 030230 surgery Placebo Placebo group Drug Administration Schedule law.invention 030207 dermatology & venereal diseases 03 medical and health sciences Crow's feet Skin aging 0302 clinical medicine Double-Blind Method Japan Randomized controlled trial Reference Values law Internal medicine medicine Humans Rejuvenation Botulinum Toxins Type A Duration of effect Facial wrinkle scale Botox Dose-Response Relationship Drug business.industry Middle Aged Treatment Outcome Neuromuscular Agents Otorhinolaryngology Patient Satisfaction Original Article Female Surgery business Follow-Up Studies |
| Zdroj: | Aesthetic Plastic Surgery |
| ISSN: | 1432-5241 0364-216X |
| DOI: | 10.1007/s00266-017-0844-9 |
| Popis: | Background This study evaluated the safety and efficacy of onabotulinumtoxinA in Japanese subjects with crow’s feet lines (CFL). Methods This phase 3, multicenter, double-blind, randomized study included 2 treatment periods: 6-month placebo-controlled period followed by a 7-month open-label period. In period 1, subjects with moderate to severe CFL received onabotulinumtoxinA 24 U (n = 104) or 12 U (n = 99), or placebo (n = 97). In period 2, placebo subjects switched to onabotulinumtoxinA 24 U or 12 U (double-blind dose). Up to 5 total treatments were permitted for subjects meeting re-treatment criteria. The primary efficacy measure was the proportion of investigator-assessed responders (achieving CFL severity of none or mild at maximum smile using the Facial Wrinkle Scale with Asian Photonumeric Guide [FWS-A] at day 30 of treatment 1). Additional endpoints included other responders (achieving at least 1-grade improvement at maximum smile and at rest using the FWS-A at day 30), responders at other time points, duration of effect, subject-reported outcomes, and safety. Results All efficacy endpoints were met. At day 30, the proportion of subjects achieving none or mild severity at maximum smile was significantly greater (P |
| Databáze: | OpenAIRE |
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