New frown line combo treatment under study
NCT ID NCT05496335
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether giving an experimental drug called AGN-151586 before BOTOX is safe and effective for treating moderate to severe frown lines between the eyebrows. About 90 adults received either the experimental drug or a placebo first, then BOTOX a month later. Researchers checked how well the lines improved and monitored for side effects over four months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AGN-151586 and OnabotulinumtoxinA (BOTOX)
- What this could lead to
- If successful, this could lead to a new treatment option for frown lines that may work well with or after BOTOX.
- What could go wrong
- This is an early phase 1 study with only 90 people, so results may not apply broadly. The experimental drug may not improve outcomes or could cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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90 people
The number who actually took part.
- Started
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Aug 2022
- Finished
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May 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants must be able to accurately assess their facial lines without the use of eyeglasses (contact lens use is acceptable). * Participants with moderate or severe Glabellar Lines at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS) at screening and baseline (Day 1) visit. Exclusion Criteria: * Uncontrolled systemic disease. * Presence or history of any medical condition that may place the participant at increased risk following exposure to AGN-151586 or BOTOX interfere with the study evaluation, including: * Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function * History of facial nerve palsy * Infection or dermatological condition at the treatment injection sites * Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart * Any eyebrow or eyelid ptosis at screening or Baseline Day 1 visit as determined by the investigator * History of clinically significant drug, nicotine, or alcohol abuse within the last 6 months. * Tattoos, jewelry, or clothing which obscure the glabellar area and cannot be removed. * History of known immunization to any botulinum neurotoxin serotype. * Anticipated need for surgery or overnight hospitalization during the study. * History of surgical procedures on forehead and/or periorbital areas or affecting these areas including any lifting procedure (e.g., rhinoplasty, facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery). * History of periorbital, mid-facial, or upper-facial treatment with semi permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation. * Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or participants with a positive polymerase chain reaction (PCR) test in the past 14 days prior to Baseline Day 1 who are asymptomatic. * Participant who has been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AboutSkin Research, LLC /ID# 244416
Greenwood Village, Colorado, 80111, United States
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Advanced Dermatology /ID# 244427
Lincolnshire, Illinois, 60069, United States
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Bellaire Dermatology Associates /ID# 244428
Bellaire, Texas, 77401, United States
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Cosmetic Laser Dermatology /ID# 244425
San Diego, California, 92121-2119, United States
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DeNova Research /ID# 244421
Chicago, Illinois, 60611, United States
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Laser and Skin Surgery Center of Indiana /ID# 244423
Indianapolis, Indiana, 46260-2386, United States
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Premier Clinical Research /ID# 244429
Spokane, Washington, 99202, United States
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Skin Research Institute LLC /ID# 244424
Coral Gables, Florida, 33146-1837, United States
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Skin and Cancer Associates, LLP /ID# 244415
Miami, Florida, 33137-3254, United States
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The Eye Research Foundation /ID# 244430
Newport Beach, California, 92663-3637, United States
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