Clinical trial NCT04985916: ET-01 in Subjects With Lateral Canthal Lines, LCL-210
Official title: Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Canthal Lines, LCL
Crow's Feet
Lead sponsor: Eirion Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-02
Enrollment: 280
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: vehicle controlled, parallel group
Primary purpose: TREATMENT

Brief summary: This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).

Detailed description: This product is being tested for its ability to reduce lateral canthal lines (LCL), also known as Crow's Feet.

Eligibility criteria: Inclusion Criteria:

* able to understand and give written informed consent
* 25 - 65 years of age
* willing to have facial pictures/videos taken per protocol
* mild or less Crow's Feet wrinkles (IGA 0-2) "at rest"
* moderate to severe Crow's Feet (IGA 3-4) "on contraction"
* ability to correctly grade a series of Crow's Feet pictures
* moderate to severe Crow's Feet (SSA 3-4) "on contraction"
* have adequate vision without the use of eyeglasses to assess facial wrinkles in a mirror (contact lenses are OK)
* willingness to refrain from the use of facial fillers, retinoids, botulinum toxins, laser treatments, or any product affecting skin remodeling or that might cause an active dermal response during the course of the study
* female subjects of childbearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline visit
* female subjects of childbearing potential must utilize one of the following methods of birth control throughout the study: intra-uterine device (IUD), diaphragm, a condom, a spermicidal gel or foam, oral contraceptives (provided subject has been utilizing this method for at least 3 months prior to Baseline and has not changed the brand within this period), or patch, injectable, implantable, or vaginal ring contraceptives. Subjects may also participate if they are surgically sterilized (tubal sterilization or hysterectomy) or are in menopause.
* subjects should be in good general health as determined by the Investigator and free of any disease that may interfere with study evaluations or the Investigational Product.

Exclusion Criteria:

* history of adverse reactions to any prior botulinum toxin treatments
* history of vaccination with botulinum toxin
* history of non-response to any prior botulinum toxin treatments
* any botulinum toxin treatment anywhere in the prior 6 months
* history of participation in ET-01-LCL-210 in previous Cohorts 1 or 2 at any time in the past
* history of periocular surgery, brow lift or related procedures
* soft tissue augmentation or any procedures affecting the lateral canthal region in the prior 12 months
* dermabrasion or laser treatment in the periocular region in the last 6 months
* topical prescription-strength retinoids in the prior 3 months to the treatment area
* application of any topical prescription medication to the treatment area within 14 days prior to treatment
* subjects on clinically significant, concomitant drug therapy (See Section 5.3 below).).
* present or history of neuromuscular disease, eyelid ptosis, muscle weakness or paralysis
* present or history of "dry eye"
* hemophilia, hemorrhagic disorder, hemostatic dysfunction or other blood clotting disorders
* use of systemic aminoglycosides in the week prior to treatment application
* participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline
* alcohol or drug abuse within the past 3 years
* psychiatric disease interfering with the subject's ability to give informed consent
* refusal or inability to comply with the requirements of the protocol for any reason

Primary outcomes:
measure: IGA (Investigators Global Assessment)
timeFrame: Week 4
Secondary outcomes:
measure: IGA (Investigators Global Assessment)
timeFrame: Week 2, 4, 8,12, and 18
measure: SSA (Subject Self-Assessment)
timeFrame: Week 2, 4, 8,12, and 18
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Eirion Research Site
state: Arizona
city: San Diego
country: United States
facility: Eirion Research Site
state: California
city: Aventura
country: United States
facility: Eirion Research Site
state: Florida
city: Boca Raton
country: United States
facility: Eirion Research Site
state: Florida
city: Miami
country: United States
facility: Eirion Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Eirion Research Site
state: Florida
city: Chicago
country: United States
facility: Eirion Research Site
state: Illinois
city: Louisville
country: United States
facility: Eirion Research Site
state: Kentucky
city: New Orleans
country: United States
facility: Eirion Research Site
state: Louisiana
city: Glenn Dale
country: United States
facility: Eirion Research Site
state: Maryland
city: Clinton Township
country: United States
facility: Eirion Research Site
state: Michigan
city: New Brighton
country: United States
facility: Eirion Research Site
state: Minnesota
city: New York
country: United States
facility: Eirion Research Site
state: New York
city: Exton
country: United States
facility: Eirion Research Site
state: Pennsylvania
city: Newtown Square
country: United States
facility: Eirion Research Site
state: Pennsylvania
city: Greenville
country: United States
facility: Eirion Research Site
state: South Carolina
city: Houston
country: United States
facility: Eirion Research Site
state: Texas
city: Plano
country: United States
facility: Eirion Research Site
state: Texas
city: Norfolk
country: United States
facility: Eirion Research Site
state: Virginia
Study officials:
References: