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

Crow's Feet Clinical Trial

Official title:

Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04985916
• Other study ID #: ET-01-LCL-210
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 19, 2021
• Est. completion date: April 2024

Study information

• Verified date: April 2024
• Source: Eirion Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crow's Feet
• Lateral Canthal Lines, LCL

Intervention

Biological:
• Vehicle
topical liniment without investigational product
• botulinum toxin, Type A
ET-01 topical liniment

Locations

Country	Name	City	State
United States	Eirion Research Site	Aventura	Florida
United States	Eirion Research Site	Boca Raton	Florida
United States	Eirion Research Site	Chicago	Illinois
United States	Eirion Research Site	Clinton Township	Michigan
United States	Eirion Research Site	Exton	Pennsylvania
United States	Eirion Research Site	Glenn Dale	Maryland
United States	Eirion Research Site	Greenville	South Carolina
United States	Eirion Research Site	Houston	Texas
United States	Eirion Research Site	Louisville	Kentucky
United States	Eirion Research Site	Miami	Florida
United States	Eirion Research Site	New Brighton	Minnesota
United States	Eirion Research Site	New Orleans	Louisiana
United States	Eirion Research Site	New York	New York
United States	Eirion Research Site	Newtown Square	Pennsylvania
United States	Eirion Research Site	Norfolk	Virginia
United States	Eirion Research Site	Plano	Texas
United States	Eirion Research Site	San Diego	California
United States	Eirion Research Site	Scottsdale	Arizona
United States	Eirion Research Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eirion Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	IGA (Investigators Global Assessment)	Investigators Global Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).	Week 2, 4, 8,12, and 18
Secondary	SSA (Subject Self-Assessment)	Subject Self-Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).	Week 2, 4, 8,12, and 18