COMPLETED

A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participants for the Change of Glabellar Lines (GL)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this Phase 1 study is to assess the safety and efficacy of single treatment of AGN-151586 and of OnabotulinumtoxinA in the glabellar complex of participants with moderate to severe glabellar lines (GL).

Official Title

A Phase 1 Study to Evaluate the Safety and Efficacy of Co-administration of AGN-151586 and BOTOX® in Subjects for Treatment of Glabellar Lines (GL)

Quick Facts

Study Start:2025-02-18
Study Completion:2025-11-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06834789

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS).
  2. * 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.
  1. * Active infection or dermatological condition at the treatment injection sites.
  2. * 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.

Contacts and Locations

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

Investigate MD /ID# 270771
Scottsdale, Arizona, 85260
United States
Eye Research Foundation /ID# 270827
Newport Beach, California, 92663
United States
Marcus Facial Plastic Surgery /ID# 270770
Redondo Beach, California, 90277
United States
Skin Research Institute LLC /ID# 270831
Coral Gables, Florida, 33146-1837
United States
Skincare Physicians /ID# 271018
Chestnut Hill, Massachusetts, 02467
United States
Wilmington Dermatology Center /ID# 270828
Wilmington, North Carolina, 28403
United States
Austin Institute for Clinical Research - Pflugerville /ID# 270834
Pflugerville, Texas, 78660
United States
SkinDC /ID# 270932
Arlington, Virginia, 22209
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-18
Study Completion Date2025-11-03

Study Record Updates

Study Start Date2025-02-18
Study Completion Date2025-11-03

Terms related to this study

Keywords Provided by Researchers

  • Glabellar Lines
  • AGN-151586
  • OnabotulinumtoxinA

Additional Relevant MeSH Terms

  • Glabellar Lines