Status:
COMPLETED
AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines
Lead Sponsor:
Allergan
Conditions:
Glabellar Lines
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2020
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT04096326
Start Date
September 26 2019
End Date
September 9 2020
Last Update
July 28 2023
Active Locations (9)
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1
Center for Dermatology Clinical Research /ID# 237798
Fremont, California, United States, 94538
2
Ava T. Shamban MD - Santa Monica. /ID# 235353
Santa Monica, California, United States, 90404-2208
3
Skin and Cancer Associates, LLP /ID# 236231
Miami, Florida, United States, 33137-3254
4
Laser and Skin Surgery Center of Indiana /ID# 236588
Indianapolis, Indiana, United States, 46260-2386