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

NCT05248867 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 638

Last updated 2024-05-24

Study results available
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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. AGN-151586 is an investigational product being developed for the treatment of GL. The purpose of this study was to evaluate the safety and efficacy of AGN-151586 for the treatment of GL in participants with moderate to severe GL.

This was a 12-week study in which eligible subjects were enrolled into the study containing 2 treatment periods, double-blind period and open-label period. Participants were randomly assigned to receive AGN-151586 or placebo. There was 1 in a 4 chance that participants would receive placebo. Around 600 adult participants with moderate to severe GL were to be enrolled in the study in approximately 38 sites across the world.

Participants received either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may have received an open-label treatment of AGN-151586 during the study.

Participants attended regular visits during the study at a study site. The effect of the treatment was checked by medical assessments, blood tests, telephone calls, questionnaires and checking for side effects.

Conditions

  • Glabellar Lines

Interventions

DRUG

Placebo

Placebo solution for injection

DRUG

AGN-151586

AGN-151586 solution for injection

Sponsors & Collaborators

Principal Investigators

  • ALLERGAN INC. · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2023-03-17
Completion
2023-03-17
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Hungary
  • Poland

Study Locations

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Entities

Drugs
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 NCT05248867 on ClinicalTrials.gov