ET-01 in Subjects With Lateral Canthal Lines, LCL-210

Eirion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Lateral Canthal Lines, LCL; Crow's Feet

Treatments: Biological: Vehicle; Biological: botulinum toxin, Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT04985916

ET-01-LCL-210

Details and patient eligibility

About

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

Full description

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

Enrollment: 280 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 3 patient groups, including a placebo group

Vehicle

Placebo Comparator group

Description:

Vehicle, topical liniment, administered once at baseline

Treatment:

Biological: Vehicle

ET-01, Dose 1

Experimental group

Description:

Dose 1 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length

Treatment:

Biological: botulinum toxin, Type A

ET-01, Dose 2

Experimental group

Description:

Dose 2 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length

Treatment:

Biological: botulinum toxin, Type A