PMID- 25347451
OWN - NLM
STAT- MEDLINE
DCOM- 20141223
LR  - 20220408
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Linking)
VI  - 40
IP  - 11
DP  - 2014 Nov
TI  - Efficacy and safety of onabotulinumtoxinA for the treatment of crows feet lines: 
      a multicenter, randomized, controlled trial.
PG  - 1181-90
LID - 10.1097/DSS.0000000000000128 [doi]
AB  - BACKGROUND: This study was part of a Phase 3 program treating crow's feet lines 
      (CFL) with onabotulinumtoxinA. OBJECTIVE: To evaluate the efficacy and safety of 
      onabotulinumtoxinA treatment of CFL. METHODS: This multicenter, double-blind, 
      placebo-controlled, 5-month study randomized subjects with moderate-to-severe CFL 
      (maximum smile) to onabotulinumtoxinA (24 U; n = 222) or placebo (n = 223). 
      Investigators and subjects assessed CFL severity (maximum smile and rest) using 
      the 4-grade Facial Wrinkle Scale (FWS). Co-primary end points were investigator- 
      and subject-assessed proportion of subjects achieving a CFL FWS grade of 0 (none) 
      or 1 (mild) at maximum smile (Day 30). Additional efficacy end points, 
      patient-reported outcomes, and safety/adverse events (AEs) were evaluated. 
      RESULTS: All primary and secondary end points were achieved; statistically 
      significant differences favored onabotulinumtoxinA (p < .001, all comparisons vs 
      placebo). Co-primary responder rates were 66.7% compared with 6.7% for 
      investigator-assessed and 58.1% compared with 5.4% for subject-assessed response 
      (onabotulinumtoxinA group and placebo, respectively; p < .001). A significantly 
      greater proportion of the onabotulinumtoxinA group than placebo group achieved a 
      1 grade or greater improvement on the FWS (maximum smile and rest assessed by 
      both the investigator and subject; all time points; p < .001). Most AEs were mild 
      or moderate and did not result in discontinuations. CONCLUSION: Treatment of 
      moderate-to-severe CFL with onabotulinumtoxinA was effective and well tolerated.
FAU - Carruthers, Alastair
AU  - Carruthers A
AD  - *Department of Dermatology and Skin Science, University of British Columbia, 
      Vancouver, British Columbia, Canada; daggerSuzanne Bruce and Associates, PA, Houston, 
      Texas; double daggerDepartment of Dermatology, Vrije Universiteit Brussel, Brussels, Belgium; 
       section signThe Private Clinic, Glasgow, United Kingdom;  ||Department of Dermatology, School 
      of Medicine, University of North Carolina, Chapel Hill, Chapel Hill, North 
      Carolina;  paragraph signAesthetic Solutions, Chapel Hill, North Carolina; #Scientific 
      Communications and Information, Parsippany, New Jersey; **Allergan, Inc., Irvine, 
      California; and daggerdaggerKythera Biopharmaceuticals Inc., Calabasas, California; and 
      double daggerdouble daggerDepartment of Medicine, Division of Dermatology, David Geffen School of 
      Medicine, University of California Los Angeles, Los Angeles, California.
FAU - Bruce, Suzanne
AU  - Bruce S
FAU - de Coninck, Arlette
AU  - de Coninck A
FAU - Connolly, Simon
AU  - Connolly S
FAU - Cox, Sue Ellen
AU  - Cox SE
FAU - Davis, Paula G
AU  - Davis PG
FAU - Campo, Antoinette
AU  - Campo A
FAU - Lei, Xiaofang
AU  - Lei X
FAU - Somogyi, Christine
AU  - Somogyi C
FAU - Lee, Elisabeth
AU  - Lee E
FAU - McLean, Helen
AU  - McLean H
FAU - Beddingfield, Frederick
AU  - Beddingfield F
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Dermatol Surg
JT  - Dermatologic surgery : official publication for American Society for Dermatologic 
      Surgery [et al.]
JID - 9504371
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Botulinum Toxins, Type A/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Skin Aging/*drug effects
EDAT- 2014/10/28 06:00
MHDA- 2014/12/24 06:00
CRDT- 2014/10/28 06:00
PHST- 2014/10/28 06:00 [entrez]
PHST- 2014/10/28 06:00 [pubmed]
PHST- 2014/12/24 06:00 [medline]
AID - 00042728-201411000-00005 [pii]
AID - 10.1097/DSS.0000000000000128 [doi]
PST - ppublish
SO  - Dermatol Surg. 2014 Nov;40(11):1181-90. doi: 10.1097/DSS.0000000000000128.