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Efficacy and safety of onabotulinumtoxinA for treating crow's feet lines alone or in combination with glabellar lines: a multicenter, randomized, controlled trial
- Source :
- Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]. 41(1)
- Publication Year :
- 2014
-
Abstract
- This was the second study in a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA.To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL alone or with glabellar lines (GL).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.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).OnabotulinumtoxinA was effective and well tolerated for treating moderate-to-severe CFL alone or in combination with GL.
- Subjects :
- Adult
Male
medicine.medical_specialty
Treatment outcome
Pain
Dermatology
Cosmetic Techniques
Eye
law.invention
Crow's feet
Randomized controlled trial
Double-Blind Method
law
Medicine
Humans
Forehead
Botulinum Toxins, Type A
Hematoma
business.industry
Headache
General Medicine
Middle Aged
Self Concept
Surgery
Skin Aging
Clinical trial
Treatment Outcome
Multicenter study
Neuromuscular Agents
Patient Satisfaction
Female
business
Subjects
Details
- ISSN :
- 15244725
- Volume :
- 41
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]
- Accession number :
- edsair.doi.dedup.....2e99de5684181ccafc62811d5fbe9869