Clinical trial NCT04096326: AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glabellar Lines
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-09-19
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7
timeFrame: Baseline (Day 1) through Day 7
measure: Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug until the end of study (up to 42 days)
measure: Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention
timeFrame: From first dose of study drug until the end of study (up to 42 days)
measure: Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention
timeFrame: From first dose of study drug until the end of study (up to 42 days)
measure: Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention
timeFrame: From first dose of study drug until the end of study (up to 42 days)
measure: Number of Participants With Anti-drug Antibodies (ADAs)
timeFrame: Up to Day 42
Secondary outcomes:
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research /ID# 237798
state: California
city: Santa Monica
country: United States
facility: Ava T. Shamban MD - Santa Monica. /ID# 235353
state: California
city: Miami
country: United States
facility: Skin and Cancer Associates, LLP /ID# 236231
state: Florida
city: Indianapolis
country: United States
facility: Laser and Skin Surgery Center of Indiana /ID# 236588
state: Indiana
city: Wilmington
country: United States
facility: Wilmington Dermatology Center /ID# 237055
state: North Carolina
city: Newtown Square
country: United States
facility: Kgl, Llc /Id# 234798
state: Pennsylvania
city: Austin
country: United States
facility: DermResearch Inc. /ID# 234483
state: Texas
city: Houston
country: United States
facility: Austin Institute for Clinical Research at SBA Dermatology /ID# 236646
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research /ID# 237135
state: Texas
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: