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NCT05496335 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines
A Phase 1 study of Glabellar Lines, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
- 10
- Study locations
NCT05496335: Completed Phase 1 study of Glabellar Lines, sponsored by AbbVie.
NCT05496335 is a Phase 1 study of Glabellar Lines that has completed, run by AbbVie. The registered enrollment target is 90 participants, below the 392-participant average among 4 other Glabellar Lines trials with a reported enrollment target (77% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05496335, a Phase 1 study of Glabellar Lines, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
- 10
- Study locations
Study Summary
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. The purpose of this study is to assess how safe and effective sequential administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) is in adult participants with moderate to severe GL. AGN-151586 is an investigational product being developed for the treatment of GL. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. One group will receive AGN-151586 followed by BOTOX and the other group will receive placebo followed by BOTOX. There is a 1 in 2 chance that participants will be assigned to placebo. Around 80 adult participants with moderate to severe GL will be enrolled in the study in approximately 10 sites around the United States. Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Eligible participants may then receive BOTOX injections on Day 30 and will be followed for up to 4 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Primary Outcome
The investigator assessment of GL severity at maximum frown using a 4-grade scale (0 to 3) where 0=none and 3=severe.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AGN-151586
- DRUG BOTOX
Study Locations (10)
California
- The Eye Research Foundation /ID# 244430 - Newport Beach
- Cosmetic Laser Dermatology /ID# 244425 - San Diego
Florida
- Skin Research Institute LLC /ID# 244424 - Coral Gables
- Skin and Cancer Associates, LLP /ID# 244415 - Miami
Illinois
- DeNova Research /ID# 244421 - Chicago
- Advanced Dermatology /ID# 244427 - Lincolnshire
Colorado
- AboutSkin Research, LLC /ID# 244416 - Greenwood Village
Indiana
- Laser and Skin Surgery Center of Indiana /ID# 244423 - Indianapolis
Texas
- Bellaire Dermatology Associates /ID# 244428 - Bellaire
Washington
- Premier Clinical Research /ID# 244429 - Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2022-08-30 |
| Est. Completion | 2023-05-30 |
| Phase | Phase 1 |
What the finished NCT05496335 record still lists
NCT05496335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 392-participant average among 4 other Glabellar Lines trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Glabellar Lines appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05496335 lists 10 locations in 7 states (California, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT05496335 about?
NCT05496335 is a clinical study titled "A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines". 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. The purpose of this study is to assess how safe and effective sequential administration of AGN-151586 and...
What is the current status of trial NCT05496335?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2022-08-30. Estimated completion is 2023-05-30.
What conditions does trial NCT05496335 study?
This clinical trial studies the following conditions: Glabellar Lines.
What interventions are being tested in trial NCT05496335?
The interventions under investigation include: Placebo (DRUG), AGN-151586 (DRUG), BOTOX (DRUG).
Who is sponsoring clinical trial NCT05496335?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05496335 being conducted?
This trial has 10 study locations across California, Colorado, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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