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NCT05152576 · ClinicalTrials.gov registry record · Phase 2
A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead Lines
A Phase 2 study of Forehead Lines, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
- 8
- Study locations
NCT05152576: Completed Phase 2 study of Forehead Lines, sponsored by Allergan.
NCT05152576 is a Phase 2 study of Forehead Lines that has completed, run by Allergan. The registered enrollment target is 124 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05152576, a Phase 2 study of Forehead Lines, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
- 8
- Study locations
Study Summary
Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. OnabotulinumtoxinA X is being investigated as another form of treatment to treat FHL by inhibiting the release of the neurotransmitter that causes the overactivity of the muscles responsible for the severity of these facial lines. The purpose of this study is to evaluate the safety and change in condition of 3 doses of OnabotulinumtoxinA X for the treatment of moderate to severe forehead lines. Study doctors will determine if a subject is eligible for the study. If so, the subject will be randomized into 1 of the 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 120 adult participants with FHL will be enrolled in the study in approximately 10 sites in the United States. Participants will receive either intramuscular injections of onabotulinumtoxinA X or placebo. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at the study site.
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG OnabotulinumtoxinA X
Study Locations (8)
California
- The Eye Research Foundation /ID# 241512 - Newport Beach
- Steve Yoelin MD Medical Associate Inc /ID# 239771 - Newport Beach
New York
- The Center for Dermatology Cosmetics & Laser Surgery /ID# 239776 - Mount Kisco
- Skin Search of Rochester Inc. /ID# 239773 - Rochester
North Carolina
- Dermatology Consulting Service /ID# 239779 - High Point
- Wilmington Dermatology Center /ID# 239778 - Wilmington
Texas
- Dallas Plastic Surgery Institute /ID# 239777 - Dallas
- Duplicate_Austin Institute for Clinical Research /ID# 239783 - Pflugerville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2021-11-29 |
| Est. Completion | 2022-09-06 |
| Phase | Phase 2 |
What the finished NCT05152576 record still lists
NCT05152576 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 1 condition, with Forehead Lines appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05152576 lists 8 locations in 4 states (California, New York, North Carolina).
Frequently Asked Questions
What is clinical trial NCT05152576 about?
NCT05152576 is a clinical study titled "A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead Lines". Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. OnabotulinumtoxinA X is being investigated as another form of treatment to treat FHL by inhibiting the re...
What is the current status of trial NCT05152576?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2021-11-29. Estimated completion is 2022-09-06.
What conditions does trial NCT05152576 study?
This clinical trial studies the following conditions: Forehead Lines.
What interventions are being tested in trial NCT05152576?
The interventions under investigation include: Placebo (DRUG), OnabotulinumtoxinA X (DRUG).
Who is sponsoring clinical trial NCT05152576?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05152576 being conducted?
This trial has 8 study locations across California, New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05152576's enrollment target sits among peer trials
124 564th of 2000 higher than 1,437 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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