A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines
Public ClinicalTrials.gov record NCT05248880. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Glabellar Lines in Toxin-Naïve Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. AGN-151586 is an investigational product being developed for the treatment of GL. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 for the treatment of GL in toxin-naïve participants with moderate to severe GL. This is a 12 week study in which eligible subjects will be enrolled into the study containing 2 treatment periods, double-blind period and open-label period. Participants are randomly assigned to receive AGN-151586 or placebo. There is 1 in a 4 chance that participants will receive placebo. Around 300 adult participants with moderate to severe GL will be enrolled in the study in approximately 15 sites. Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may receive an open-label treatment of AGN-151586 during the study. Participants will attend regular visits during the study at a study site. The effect of the treatment will be checked by medical assessments, blood tests, telephone calls, questionnaires and checking for side effects.
Study identification
- NCT ID
- NCT05248880
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 309 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 8, 2022 (Actual)
- Primary completion
- Feb 1, 2023 (Actual)
- Completion
- Feb 1, 2023 (Actual)
- Last update posted
- Feb 18, 2026
2022 – 2023
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clear Dermatology & Aesthetics Center /ID# 238990 | Scottsdale | Arizona | 85255-4134 | — |
| Steve Yoelin MD Medical Associate Inc /ID# 243197 | Newport Beach | California | 92663 | — |
| Marcus Medical Spa /ID# 241703 | Redondo Beach | California | 90277 | — |
| DMR Research PLLC /ID# 239061 | Westport | Connecticut | 06880 | — |
| Duplicate_Kavali Plastic Surgery and Skin Renewal Center /ID# 244808 | Atlanta | Georgia | 30328 | — |
| DelRicht Research /ID# 244890 | Baton Rouge | Louisiana | 70809 | — |
| Maryland Dermatology Laser, Skin, & Vein Institute /ID# 239067 | Hunt Valley | Maryland | 21030-3216 | — |
| WDC Cosmetic and Research, PLLC /ID# 233935 | Wilmington | North Carolina | 28405 | — |
| Clinical Research Center of the Carolinas /ID# 239064 | Charleston | South Carolina | 29407 | — |
| Duplicate_Austin Institute for Clinical Research /ID# 238989 | Pflugerville | Texas | 78660 | — |
| Kalo Clinical Research /ID# 247279 | West Valley City | Utah | 84120-2058 | — |
| SkinDC /ID# 238988 | Arlington | Virginia | 22209 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05248880, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 18, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05248880 live on ClinicalTrials.gov.