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COMPLETED
NCT05496335
PHASE1

A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

Official title: A Phase 1 Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) in Subjects for Treatment of Glabellar Lines

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2022-08-30

Completion Date

2023-05-30

Last Updated

2026-06-26

Healthy Volunteers

No

Conditions

Interventions

DRUG

AGN-151586

Intramuscular Injection

DRUG

BOTOX

Intramuscular Injection

DRUG

Placebo

Intramuscular Injection

Locations (10)

The Eye Research Foundation /ID# 244430

Newport Beach, California, United States

Cosmetic Laser Dermatology /ID# 244425

San Diego, California, United States

AboutSkin Research, LLC /ID# 244416

Greenwood Village, Colorado, United States

Skin Research Institute LLC /ID# 244424

Coral Gables, Florida, United States

Skin and Cancer Associates, LLP /ID# 244415

Miami, Florida, United States

DeNova Research /ID# 244421

Chicago, Illinois, United States

Advanced Dermatology /ID# 244427

Lincolnshire, Illinois, United States

Laser and Skin Surgery Center of Indiana /ID# 244423

Indianapolis, Indiana, United States

Bellaire Dermatology Associates /ID# 244428

Bellaire, Texas, United States

Premier Clinical Research /ID# 244429

Spokane, Washington, United States