Phase 3
Completed 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
Source: ClinicalTrials.gov NCT01224015 ↗
Enrolled (actual)
684
Serious AEs
1.2%
Results posted
Feb 2014
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.