Facial Wrinkles
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Facial Wrinkles
M21-500 Enrolling

Research Trial for Glabellar (Frown) Lines (14 Weeks)


Age: 18 Years

Adults at least 18 years old with moderate or severe Glabellar Lines (GL) at maximum frown, may qualify to participate in this research trial. These wrinkles between the eyebrows are ones that develop from repeated facial expression. Qualified individuals must not have uncontrolled systemic disease, a history of any use of botulinum neurotoxin for any indication, or have a history of any medical condition that may interfere with the study evaluation.

Participants will receive investigational medication (active study drug) or placebo via injection. Study medication and study-related care will be provided at no cost to you. Reimbursement for study-related expenses (e.g. travel costs) may be provided.

Study participation will last about 14 weeks and involve about 24 visits to the study centre.


Official Title

A Phase 3, Multicenter Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Glabellar Lines

ClinicalTrials.gov ID

NCT05248867

Study Description

  • Condition or Disease:

    Glabellar Lines

  • Intervention/Treatment:

    Drug: AGN-151586 Drug: AGN-151586,Drug: Placebo
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and older (Adult,Older Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Participants must be able to accurately assess their facial lines without the use of eyeglasses (contact lens use is acceptable).
Participant must have 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 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 known immunization to any botulinum neurotoxin serotype.
Participants who have reported use of any botulinum neurotoxin of any serotype (including any investigational botulinum neurotoxin product) for aesthetic treatment within the last 6 months prior to Baseline (Day 1 of treatment) and for therapeutic treatment within the last 12 months prior to study drug administration.
Tattoos, jewelry, or clothing which obscure the glabellar area and cannot be removed.
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 subjects with a positive polymerase chain reaction (PCR) test in the past 14 days prior to Baseline Day 1 who are asymptomatic.
Female subject who is pregnant or breastfeeding, and is considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug or until the end of study, whichever is longer.
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.
Anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study drug).


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Melinda Gooderham

Dermatologist

Dr. Susan Poelman

Dermatologist

Dr. Andrei Metelitsa

Dermatologist

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