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

NCT04985916 | Completed Phase 2 FDA Drug

• 1 other identifier: ET-01-LCL-210
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Lateral Canthal Lines, LCL; Crow's Feet

Outcome Measures

Primary Outcomes (1)

• IGA (Investigators Global Assessment)

  Investigators Global Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).

  Week 4

Secondary Outcomes (2)

• IGA (Investigators Global Assessment)

  Week 2, 4, 8,12, and 18

• SSA (Subject Self-Assessment)

  Week 2, 4, 8,12, and 18

Study Arms (3)

Vehicle

PLACEBO COMPARATOR

Vehicle, topical liniment, administered once at baseline

Biological: Vehicle

ET-01, Dose 1

EXPERIMENTAL

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

Biological: botulinum toxin, Type A

ET-01, Dose 2

EXPERIMENTAL

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

Biological: botulinum toxin, Type A

Interventions

Vehicle BIOLOGICAL

topical liniment without investigational product

Also known as: ET-01 Vehicle

Vehicle

botulinum toxin, Type A BIOLOGICAL

ET-01 topical liniment

Also known as: ET-01

ET-01, Dose 1; ET-01, Dose 2

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able to understand and give written informed consent
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eirion Therapeutics Inc.: lead

Study Sites (19)

Eirion Research Site

Scottsdale, Arizona, 85255, United States

Location

Eirion Research Site

San Diego, California, 92121, United States

Location

Eirion Research Site

Aventura, Florida, 33180, United States

Location

Eirion Research Site

Boca Raton, Florida, 33486, United States

Location

Eirion Research Site

Miami, Florida, 33137, United States

Location

Eirion Research Site

West Palm Beach, Florida, 33401, United States

Location

Eirion Research Site

Chicago, Illinois, 60654, United States

Location

Eirion Research Site

Louisville, Kentucky, 40241, United States

Location

Eirion Research Site

New Orleans, Louisiana, 70124, United States

Location

Eirion Research Site

Glenn Dale, Maryland, 20769, United States

Location

Eirion Research Site

Clinton Township, Michigan, 48038, United States

Location

Eirion Research Site

New Brighton, Minnesota, 55112, United States

Location

Eirion Research Site

New York, New York, 10075, United States

Location

Eirion Research Site

Exton, Pennsylvania, 19341, United States

Location

Eirion Research Site

Newtown Square, Pennsylvania, 19073, United States

Location

Eirion Research Site

Greenville, South Carolina, 29615, United States

Location

Eirion Research Site

Houston, Texas, 77056, United States

Location

Eirion Research Site

Plano, Texas, 75093, United States

Location

Eirion Research Site

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: vehicle controlled, parallel group

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 2, 2021
• Study Start: July 19, 2021
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)