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A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines

NCT05248893 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 986

Last updated 2024-05-29

No results posted yet for this 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 evaluate the safety of AGN-151586 over multiple repeat treatments of the study drug to improve the appearance of glabellar lines.

AGN-151586 is an investigational product being developed for the treatment of GL. Around 940 to 1100 adult participants with moderate to severe GL will be enrolled in the study in approximately 45 sites in the United States.

This is an open-label, 126 day study in which all participants will receive 5 intramuscular AGN-151586 injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may receive up to 2 additional cycles of treatment 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.

Conditions

  • Glabellar Lines

Interventions

DRUG

AGN-151586

Intramuscular Injection

Sponsors & Collaborators

Principal Investigators

  • ALLERGAN INC. · Allergan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-25
Primary Completion
2023-06-26
Completion
2023-06-26
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05248893 on ClinicalTrials.gov