Phase 3
N=684
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
Facial Rhytides · Crow's Feet Lines · Glabellar Lines
Bottom Line
View on ClinicalTrials.gov: NCT01224015 ↗Enrolled (actual)
684
Serious AEs
1.2%
Results posted
Feb 2014
Primary outcome: Primary: Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines — 63.6; 56.5; 1.1 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- normal saline (Drug); onabotulinumtoxinA 44 U (Biological); onabotulinumtoxinA 24 U (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines |
63.6; 56.5; 1.1 | — |
Summary
This study will evaluate the safety and efficacy of botulinum toxin type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides) for patients who successfully completed Study 191622-099.
Eligibility Criteria
Inclusion Criteria
- Successfully completed Study 191622-099
Exclusion Criteria
- Known immunization or hypersensitivity to botulinum toxin of any serotype
- Anticipated need for treatment with botulinum toxin of any serotype during the study (except for study treatment)
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- Anticipated need for surgery or hospitalization during the study
Data sourced from ClinicalTrials.gov (NCT01224015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.