Assessing the safety of AGN-151586 and OnabotulinumtoxinA for treating glabellar lines
A Phase 1 Study With AGN-151586 and OnabotulinumtoxinA in Subjects for Treatment of Glabellar Lines (GL)
This study is testing whether a new treatment combined with a popular wrinkle injection can safely improve the appearance of frown lines in adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 8 sites (Scottsdale, Arizona and 7 other locations) |
| Trial ID | NCT06834789 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study aims to evaluate the safety and efficacy of a single treatment with AGN-151586 and OnabotulinumtoxinA in adults with moderate to severe glabellar lines. Participants will receive either the active treatments or a placebo, and their responses will be assessed using the Facial Wrinkle Scale. The study focuses on understanding the adverse events associated with these injections to determine their suitability for broader use in cosmetic applications.
Who should consider this trial
Good fit: Ideal candidates are adults with moderate to severe glabellar lines who are in good health.
Not a fit: Patients with active infections or dermatological conditions at the injection sites, or those with a history of hypersensitivity to botulinum neurotoxins, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for individuals seeking to reduce the appearance of glabellar lines.
How similar studies have performed: Other studies have shown success with similar botulinum toxin treatments, indicating a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Has moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS). * Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, 12-lead ECG parameters, clinical laboratory evaluations, and neurological assessment. Exclusion Criteria: * Active infection or dermatological condition at the treatment injection sites. * History of immunization to any botulinum neurotoxin serotype or hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug or its excipients, and/or other products in the same class.
Where this trial is running
Scottsdale, Arizona and 7 other locations
- Investigate MD /ID# 270771 — Scottsdale, Arizona, United States (Recruiting)
- Eye Research Foundation /ID# 270827 — Newport Beach, California, United States (Recruiting)
- Marcus Facial Plastic Surgery /ID# 270770 — Redondo Beach, California, United States (Recruiting)
- Skin Research Institute LLC /ID# 270831 — Coral Gables, Florida, United States (Recruiting)
- Skincare Physicians /ID# 271018 — Chestnut Hill, Massachusetts, United States (Recruiting)
- Wilmington Dermatology Center /ID# 270828 — Wilmington, North Carolina, United States (Recruiting)
- Austin Institute for Clinical Research - Pflugerville /ID# 270834 — Pflugerville, Texas, United States (Recruiting)
- SkinDC /ID# 270932 — Arlington, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.