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Dermatol Surg. 2015 Jun;41(6):702-11. doi: 10.1097/DSS.0000000000000357.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Repeated OnabotulinumtoxinA Treatments in Subjects With Crow's Feet Lines and Glabellar Lines.

Author information

1
*Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada; †Division of Dermatology, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California; ‡Department of Dermatology, Yale University School of Medicine, New Haven, Connecticut; §Department of Dermatology, Tulane University School of Medicine, New Orleans, Louisiana; ‖Division of Dermatology, University of Toronto, Toronto, Ontario, Canada; ¶Allergan, Inc., Irvine, California; #SCI Scientific Communications & Information, Parsippany, New Jersey. C. Somogyi and F. C. Beddingfield are now at Kythera Biopharmaceuticals, Inc., Calabasas, California.

Abstract

BACKGROUND:

This is the third study in a Phase 3 program evaluating onabotulinumtoxinA treatment of crow's feet lines (CFL).

OBJECTIVE:

To assess the efficacy and safety of repeated onabotulinumtoxinA treatments of CFL alone or with glabellar lines (GL) in subjects with moderate-to-severe CFL and GL (maximum smile).

MATERIALS AND METHODS:

This 5-month extension of a 7-month study randomized subjects who originally received onabotulinumtoxinA 24 U (CFL only; n = 227) or 44 U (24 U for CFL + 20 U for GL; n = 260) to retreatment with the same dose. Placebo-treated subjects were rerandomized to onabotulinumtoxinA 44 U (n = 101) or placebo (n = 96). Primary efficacy end point (Day 30) was the proportion of subjects who achieved a CFL severity rating of none or mild (maximum smile) on the investigator-assessed Facial Wrinkle Scale (FWS). Additional efficacy end points and adverse events were evaluated.

RESULTS:

Responder rates (primary end point) were significantly greater in onabotulinumtoxinA-treated groups (24 U: 56.5%; 44 U: 63.6%; placebo: 1.1%; p < .001). Improvements on most patient-reported outcomes (PROs) favored the 44-U group over the 24-U group. Adverse events did not differ among groups; most were mild or moderate.

CONCLUSION:

Repeated onabotulinumtoxinA treatments significantly reduce CFL severity based on FWS and PROs. Adverse event profiles remain consistent with approved GL labeling.

PMID:
25993609
DOI:
10.1097/DSS.0000000000000357
[Indexed for MEDLINE]

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