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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096326
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Glabellar Lines Drug: AGN-151586 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of AGN-151586 in Participants With Moderate to Severe Glabellar Lines
Actual Study Start Date : September 26, 2019
Estimated Primary Completion Date : August 12, 2020
Estimated Study Completion Date : September 10, 2020

Arm Intervention/treatment
Experimental: AGN-151586 Drug: AGN-151586
Participants will receive 5 injections (1 in the procerus, 2 in each of the bilateral corrugators). Up to 5 cohorts will be enrolled in this study.

Placebo Comparator: Placebo Drug: Placebo
Participants will receive 5 injections (1 in the procerus, 2 in each of the bilateral corrugators) of placebo matched AGN-151586




Primary Outcome Measures :
  1. Efficacy: To compare the efficacy between placebo and a range of doses of AGN-151586 for the treatment of GL (Glabellar Lines) in participants with moderate to severe GL [ Time Frame: Baseline Day 1 to Day 7 ]

    Achievement of a ≥ 2-grade improvement from baseline on the FWS (Facial Wrinkle Scale With Photonumeric Guide) according to investigator assessments of GL severity at maximum frown at any postintervention timepoint through Day 7.

    The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe


  2. Safety: To compare the safety between placebo and a range of doses of AGN-151586 for the treatment of GL in participants with moderate to severe GL [ Time Frame: Baseline Day 1 to Day 42 ]
    To assess the safety of treatment with AGN-151586 in participants based on the number of participants who experience one or more Treatment Emergent Adverse Events (TEAE).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096326


Contacts
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Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

Locations
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United States, California
Center for Dermatology Clinical Research, Inc. Recruiting
Fremont, California, United States, 94538
Contact    510-797-0140 ext 7      
Ava T. Shamban MD, INC Recruiting
Santa Monica, California, United States, 90404
Contact    310-828-2282      
United States, Florida
Baumann Cosmetic and Research Institute Recruiting
Miami, Florida, United States, 33137
Contact    305-531-5788      
United States, Indiana
Laser & Skin Surgery Center of Indiana Recruiting
Indianapolis, Indiana, United States, 46260
Contact    317-660-4900      
United States, North Carolina
WDC Cosmetic and Research, PLLC Recruiting
Wilmington, North Carolina, United States, 28403
Contact    910-256-4350      
United States, Pennsylvania
KGL LLC Recruiting
Broomall, Pennsylvania, United States, 19008
Contact    610-544-1715      
United States, Texas
DermResearch, Inc. Recruiting
Austin, Texas, United States, 78759
Contact    512-349-9889      
Suzanne Bruce and Associates; The Center for Skin Research Recruiting
Houston, Texas, United States, 77056
Contact    713-850-0240      
Austin Institute for Clinical Research, Inc. Recruiting
Pflugerville, Texas, United States, 78660
Contact    512-279-2545      
Sponsors and Collaborators
Allergan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT04096326    
Other Study ID Numbers: 2034-201-008
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No