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NCT05013424 · ClinicalTrials.gov registry record · Phase 2
A Study of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
A Phase 2 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
NCT05013424: Completed Phase 2 study, sponsored by Allergan.
NCT05013424 is a Phase 2 study that has completed, run by Allergan. The registered enrollment target is 92 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05013424, a Phase 2 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
Study Summary
Hyperfunctional facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. BOTOX (onabotulinumtoxinA) was first approved for aesthetic treatment of glabellar lines in 2001 and is one of the most common nonsurgical procedures in aesthetic medicine. This is a proof-of-concept study to evaluate how safe this new OnabotA X formulation is in treating adult participants with GL . OnabotA X is an onabotulinumtoxinA investigational product being developed for the treatment of moderate to severe glabellar lines (GL). This is a 180-day, open-label study to assess the safety of a single dose of 3 different formulations of OnabotA X (A, B \& C; each with varying amounts of the standard excipients in the formulation) in adult subjects with moderate to severe GL. Around 90 participants will be enrolled in the study in approximately 5 sites in the United States. Participants will receive one dose of OnabotA X administered as 5 injections on Day 1. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant dis
Interventions
- DRUG Formulation A: OnabotulinumtoxinA
- DRUG Formulation B: OnabotulinumtoxinA
- DRUG Formulation C: OnabotulinumtoxinA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2022-07-07 |
| Phase | Phase 2 |
What the finished NCT05013424 record still lists
NCT05013424 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 3 interventions - of which Formulation A: OnabotulinumtoxinA is the first listed.
NCT05013424 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05013424 about?
NCT05013424 is a clinical study titled "A Study of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines". Hyperfunctional facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. BOTOX (onabotulinumtoxinA) was first approved for aesthetic treatment of glabellar lines ...
What is the current status of trial NCT05013424?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2021-09-01. Estimated completion is 2022-07-07.
What interventions are being tested in trial NCT05013424?
The interventions under investigation include: Formulation A: OnabotulinumtoxinA (DRUG), Formulation B: OnabotulinumtoxinA (DRUG), Formulation C: OnabotulinumtoxinA (DRUG).
Who is sponsoring clinical trial NCT05013424?
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 NCT05013424's enrollment target sits among peer trials
92 767th of 2000 higher than 1,230 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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