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NCT01224015 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
A Phase 3 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 684
- Enrollment target
NCT01224015: Completed Phase 3 study, sponsored by Allergan.
NCT01224015 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 684 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01224015, a Phase 3 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 684 participants
- Enrollment target
Study 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.
Primary Outcome
The investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.
Interventions
- DRUG normal saline
- BIOLOGICAL onabotulinumtoxinA 24 U
- BIOLOGICAL onabotulinumtoxinA 44 U
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 684 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-02 |
| Phase | Phase 3 |
What the finished NCT01224015 record still lists
NCT01224015 is an interventional study that assigns participants to a tested intervention. The registered 684 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 3 interventions - of which normal saline is the first listed.
NCT01224015 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01224015 about?
NCT01224015 is a clinical study titled "Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines". 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.
What is the current status of trial NCT01224015?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 684 participants. The study started on 2011-05. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01224015?
The interventions under investigation include: normal saline (DRUG), onabotulinumtoxinA 24 U (BIOLOGICAL), onabotulinumtoxinA 44 U (BIOLOGICAL).
Who is sponsoring clinical trial NCT01224015?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01224015's enrollment target sits among peer trials
684 528th of 2000 higher than 1,472 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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