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NCT01391312 · ClinicalTrials.gov registry record · Phase 4
Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines
A Phase 4 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT01391312: Completed Phase 4 study, sponsored by Allergan.
NCT01391312 is a Phase 4 study that has completed, run by Allergan. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01391312, a Phase 4 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.
Primary Outcome
Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved.
Interventions
- BIOLOGICAL botulinum toxin Type A
- DRUG normal saline (placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-06 |
| Est. Completion | 2011-10 |
| Phase | Phase 4 |
What the finished NCT01391312 record still lists
NCT01391312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which botulinum toxin Type A is the first listed.
NCT01391312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01391312 about?
NCT01391312 is a clinical study titled "Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines". This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.
What is the current status of trial NCT01391312?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2011-06. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01391312?
The interventions under investigation include: botulinum toxin Type A (BIOLOGICAL), normal saline (placebo) (DRUG).
Who is sponsoring clinical trial NCT01391312?
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 NCT01391312's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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