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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 is a Phase 2 study that has completed, run by Allergan. The registered enrollment target is 92 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05013424
The ClinicalTrials.gov registry entry for NCT05013424 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Formulation A: OnabotulinumtoxinA is the first listed.
NCT05013424 reports 0 study locations.
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.
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