AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines
Completed · Phase 2 · Has a placebo group
Conditions studied: Glabellar Lines
In brief
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).
Key facts
- Study ID
- NCT04096326
- Run by
- Allergan
- People needed
- 198
- Starts
- 2019-09-26
- Expected to finish
- 2020-09-09
- Last updated by the study team
- 2023-07-28
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- Center for Dermatology Clinical Research /ID# 237798 — Fremont, California, United States
- Ava T. Shamban MD - Santa Monica. /ID# 235353 — Santa Monica, California, United States
- Skin and Cancer Associates, LLP /ID# 236231 — Miami, Florida, United States
- Laser and Skin Surgery Center of Indiana /ID# 236588 — Indianapolis, Indiana, United States
- Wilmington Dermatology Center /ID# 237055 — Wilmington, North Carolina, United States
- Kgl, Llc /Id# 234798 — Newtown Square, Pennsylvania, United States
- DermResearch Inc. /ID# 234483 — Austin, Texas, United States
- Austin Institute for Clinical Research at SBA Dermatology /ID# 236646 — Houston, Texas, United States
- Austin Institute for Clinical Research /ID# 237135 — Pflugerville, Texas, United States
Full record on ClinicalTrials.gov
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