MedDataX Logo

AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines

NCT ID: NCT04096326

Last Updated: 2023-07-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-26

Study Completion Date

2020-09-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety and efficacy of AGN-151586 over a range of doses for the treatment of moderate to severe glabellar lines (GL).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05248893

Glabellar Lines
COMPLETED PHASE3

A Study to Evaluate AGN-151586 Intramuscular Injections in Adult Participants for Treatment of Glabellar Lines

NCT06308198

Glabellar Lines
COMPLETED PHASE3

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)

NCT06834789

Glabellar Lines
COMPLETED PHASE1

Study of AGN-151586 in Japanese Participants With Moderate to Severe Glabellar Lines

NCT06151561

Moderate to Severe Glabellar Lines
COMPLETED PHASE1

Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Glabellar Lines

NCT04143815

Glabellar Frown Lines
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glabellar Lines

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1: Placebo

Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo solution for injection.

Cohort 1: AGN-151586

Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1.

Group Type EXPERIMENTAL

AGN-151586

Intervention Type DRUG

AGN-151586 solution for injection.

Cohort 2: Placebo

Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo solution for injection.

Cohort 2: AGN-151586

Participants received AGN-151586, IM injections in the glabellar complex on Day 1.

Group Type EXPERIMENTAL

AGN-151586

Intervention Type DRUG

AGN-151586 solution for injection.

Cohort 3: Placebo

Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo solution for injection.

Cohort 3: AGN-151586

Participants received AGN-151586, IM injections in the glabellar complex on Day 1.

Group Type EXPERIMENTAL

AGN-151586

Intervention Type DRUG

AGN-151586 solution for injection.

Cohort 4: Placebo

Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo solution for injection.

Cohort 4: AGN-151586

Participants received AGN-151586, IM injections in the glabellar complex on Day 1.

Group Type EXPERIMENTAL

AGN-151586

Intervention Type DRUG

AGN-151586 solution for injection.

Cohort 5: Placebo

Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo solution for injection.

Cohort 5: AGN-151586

Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1.

Group Type EXPERIMENTAL

AGN-151586

Intervention Type DRUG

AGN-151586 solution for injection.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AGN-151586

AGN-151586 solution for injection.

Intervention Type DRUG

Placebo

Placebo solution for injection.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

-Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period (at least 10 weeks after study intervention).

Exclusion Criteria

* Known immunization or hypersensitivity to any botulinum neurotoxin serotype
* Any medical condition that may put the participant at increased risk with exposure to AGN-151586, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
* Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or the inability to substantially lessen facial lines even by physically spreading them apart, as determined by the investigator
* Any brow or eyelid ptosis, as determined by the investigator
* Infection or skin disorder at the injection sites
* History of facial nerve palsy
* Any uncontrolled systemic disease
* Anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study intervention)
* Anticipated need for surgery or overnight hospitalization during the study
* Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid \[blepharoplasty\] and/or eyebrow surgery)
* Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ALLERGAN INC.

Role: STUDY_DIRECTOR

Allergan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center for Dermatology Clinical Research /ID# 237798

Fremont, California, United States

Site Status

Ava T. Shamban MD - Santa Monica. /ID# 235353

Santa Monica, California, United States

Site Status

Skin and Cancer Associates, LLP /ID# 236231

Miami, Florida, United States

Site Status

Laser and Skin Surgery Center of Indiana /ID# 236588

Indianapolis, Indiana, United States

Site Status

Wilmington Dermatology Center /ID# 237055

Wilmington, North Carolina, United States

Site Status

Kgl, Llc /Id# 234798

Newtown Square, Pennsylvania, United States

Site Status

DermResearch Inc. /ID# 234483

Austin, Texas, United States

Site Status

Austin Institute for Clinical Research at SBA Dermatology /ID# 236646

Houston, Texas, United States

Site Status

Austin Institute for Clinical Research /ID# 237135

Pflugerville, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

http://www.AllerganClinicalTrials.com

Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact [email protected] for assistance

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2034-201-008

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treatment of Moderate to Severe Glabellar Lines
NCT04249583 COMPLETED PHASE3
MT10109L in the Treatment of Glabellar Lines
NCT03795922 COMPLETED PHASE3
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines
NCT03736928 COMPLETED PHASE2
Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines
NCT05146999 COMPLETED PHASE3
MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)
NCT03721016 COMPLETED PHASE3
Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study I
NCT02677298 COMPLETED PHASE3
Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines
NCT02236312 COMPLETED PHASE2
Safety and Efficacy Study of ATGC-100 for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects
NCT03970876 COMPLETED PHASE1/PHASE2
Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines
NCT03004248 COMPLETED PHASE3
MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines
NCT03732833 COMPLETED PHASE3
MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
NCT04157686 COMPLETED PHASE3
A Phase II Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
NCT05217355 COMPLETED PHASE2
Comparison of Escalating Doses of IncobotulinumtoxinA (Xeomin®) in the Treatment of Glabellar Rhytids
NCT01583478 UNKNOWN PHASE4
Treatment of Moderate to Severe Glabellar Lines (BMI2006)
NCT05531968 COMPLETED PHASE3
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines
NCT00770211 COMPLETED PHASE3
Subject Satisfaction With AbobutulinumtoxinA Treatment
NCT03687736 COMPLETED PHASE4
Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines
NCT04225260 COMPLETED PHASE3
Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines
NCT03960957 COMPLETED PHASE3
Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines
NCT06411002 COMPLETED PHASE2
Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Glabellar Lines
NCT05059587 COMPLETED PHASE3
A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection (CU-20101)
NCT06585696 COMPLETED PHASE3
Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines
NCT04259086 COMPLETED PHASE2
Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination
NCT04247074 COMPLETED PHASE3
To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines
NCT01791920 COMPLETED PHASE3
AI-09 In Subjects With Glabellar Lines, GL-101
NCT05565950 COMPLETED PHASE1/PHASE2