PMID- 25485803
OWN - NLM
STAT- MEDLINE
DCOM- 20150313
LR  - 20220408
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Linking)
VI  - 41
IP  - 1
DP  - 2015 Jan
TI  - Efficacy and safety of onabotulinumtoxinA for treating crow's feet lines alone or 
      in combination with glabellar lines: a multicenter, randomized, controlled trial.
PG  - 102-12
LID - 10.1097/DSS.0000000000000220 [doi]
AB  - BACKGROUND: This was the second study in a Phase 3 program treating crow's feet 
      lines (CFL) with onabotulinumtoxinA. OBJECTIVE: To evaluate the efficacy and 
      safety of onabotulinumtoxinA treatment of CFL alone or with glabellar lines (GL). 
      METHODS: This multicenter, double-blind, placebo-controlled, repeat treatment, 
      7-month study randomized subjects with moderate-to-severe CFL and GL (maximum 
      contraction) to onabotulinumtoxinA 44 U (CFL: 24 U, GL: 20 U; n = 305), 
      onabotulinumtoxinA 24 U (CFL: 24 U, GL: placebo; n = 306), or placebo (n = 306). 
      Coprimary end points were investigator-assessed and subject-assessed proportion 
      of subjects achieving a CFL Facial Wrinkle Scale Grade of 0 or 1 (maximum smile; 
      Day 30, Cycle 1). Additional efficacy end points 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). Investigator and subject responder rates were: CFL, 
      54.9% and 45.8%; CFL + GL, 59.0% and 48.5%; and placebo, 3.3% (both), 
      respectively. Responder rates on other end points also significantly favored 
      onabotulinumtoxinA treatments. Most AEs were mild or moderate. Two subjects 
      discontinued: 1 serious AE unrelated to treatment (myocardial infarction) and 1 
      treatment-related AE (injection site pain). CONCLUSION: OnabotulinumtoxinA was 
      effective and well tolerated for treating moderate-to-severe CFL alone or in 
      combination with GL.
FAU - Moers-Carpi, Marion
AU  - Moers-Carpi M
AD  - *Private Clinic, Hautok, Munich, Germany; daggerDepartment of Ophthalmology and Visual 
      Sciences, University of British Columbia, Vancouver, BC, Canada; double daggerPrivate 
      Practice, Boca Raton, Florida;  section signDepartment of Dermatology, Tulane University 
      School of Medicine, New Orleans, Louisiana;  ||Private Practice, New Orleans, 
      Louisiana;  paragraph signCentre de Chirurgie Esthetique du Cap d'Antibes, Cap d'Antibes, 
      France; #Division of Dermatology, David Geffen School of Medicine, University of 
      California at Los Angeles, Los Angeles, California; **Allergan, Inc., Irvine, 
      California; daggerdaggerSCI Scientific Communications and Information, Parsippany, New 
      Jersey. Dr. Beddingfield and Ms. Somogyi are now at Kythera Biopharmaceuticals, 
      Inc., Calabasas, California.
FAU - Carruthers, Jean
AU  - Carruthers J
FAU - Fagien, Steven
AU  - Fagien S
FAU - Lupo, Mary
AU  - Lupo M
FAU - Delmar, Henry
AU  - Delmar H
FAU - Jones, Derek
AU  - Jones D
FAU - Somogyi, Christine
AU  - Somogyi C
FAU - Lee, Elisabeth
AU  - Lee E
FAU - Lei, Xiaofang
AU  - Lei X
FAU - MacKinnon, Suzanne
AU  - MacKinnon S
FAU - Davis, Paula G
AU  - Davis PG
FAU - Yalamanchili, Ramana
AU  - Yalamanchili R
FAU - Campo, Antoinette
AU  - Campo A
FAU - Beddingfield, Frederick C 3rd
AU  - Beddingfield FC 3rd
LA  - eng
PT  - Clinical Trial, Phase III
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  - 0 (Neuromuscular Agents)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
SB  - IM
MH  - Adult
MH  - Botulinum Toxins, Type A/adverse effects/*therapeutic use
MH  - *Cosmetic Techniques/adverse effects/psychology
MH  - Double-Blind Method
MH  - Eye
MH  - Female
MH  - Forehead
MH  - Headache/chemically induced
MH  - Hematoma/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neuromuscular Agents/adverse effects/*therapeutic use
MH  - Pain/chemically induced
MH  - Patient Satisfaction
MH  - Self Concept
MH  - *Skin Aging
MH  - Treatment Outcome
EDAT- 2014/12/09 06:00
MHDA- 2015/03/17 06:00
CRDT- 2014/12/09 06:00
PHST- 2014/12/09 06:00 [entrez]
PHST- 2014/12/09 06:00 [pubmed]
PHST- 2015/03/17 06:00 [medline]
AID - 10.1097/DSS.0000000000000220 [doi]
PST - ppublish
SO  - Dermatol Surg. 2015 Jan;41(1):102-12. doi: 10.1097/DSS.0000000000000220.