ET-01 in Subjects With Lateral Canthal Lines, LCL-208

Phase 2

Completed

• Conditions: Lateral Canthal Lines; Crow's Feet
• Interventions: Biological: Vehicle; Biological: botulinum toxin, Type A

• Registration Number: NCT03839693
• Lead Sponsor: Eirion Therapeutics Inc.

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, also known as Crow's Feet.

Study Timeline

• Study Start: 2018-10-16
• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-02-11
• Study First Posted: 2019-02-15
• Primary Completion: 2019-04-18
• Study Completion: 2019-09-19
• Disposition First Submitted: 2020-05-20
• Results First Submitted: 2022-05-20
• Results First Submitted QC: 2022-06-30
• Disposition First Submitted QC: 2022-06-30
• Status Verified: 2022-07
• Results First Posted: 2022-07-26
• Disposition First Posted: 2022-07-26
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• females 25 - 65 years of age
• minimal to moderate Crow's Feet wrinkles at rest
• moderate to severe Crow's Feet on contraction
• adequate vision to assess facial wrinkles in a mirror
• willingness to refrain from products affecting skin remodeling
• female subjects must be not pregnant and non-lactating
• subjects should be in good general health

Exclusion Criteria

• history of adverse reactions to any prior botulinum toxin treatments
• history of vaccination or non-response to any prior botulinum toxin treatments
• botulinum toxin treatment in the prior 6 months
• present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"
• history of peri-ocular surgery, brow lift or related procedures
• procedures affecting the lateral canthal region in the prior 12 months
• application of topical prescription medication to the treatment area
• female subjects who are pregnant or are nursing a child

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Vehicle
ET-01 1100U	botulinum toxin, Type A	botulinum toxin, Type A, Dose 2, 1100 U
ET-01 345U	botulinum toxin, Type A	botulinum toxin, Type A, Dose 1, 345 U

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Response Defined as Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4	Week 4	Investigators Global Assessment of the Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). Response is defined as change by at least two ordinals from Baseline to Week 4.

Secondary Outcome Measures

Name	Time	Method
Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit	Week 1, 2, 4, 8,12,18, and 26	Total number of observations with a change in the Investigators Global Assessment on Contraction, IGA-C, and the Subject Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26.
Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Time Between Week 4 and Week 12	Week 4, 8,and 12	Total number of observations with a change by at least two ordinals in the Subjects Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as an improvement ≥ 2 score points. The observation period covers the time time of expected peak efficacy from Week 4 to Week 12.

Trial Locations

Locations (5)

Synexus, Inc.; 🇺🇸 Pinellas Park, Florida, United States

Virginia Clinical Research, Inc.; 🇺🇸 Norfolk, Virginia, United States

Baumann Cosmetic & Research Institute; 🇺🇸 Miami, Florida, United States

Westlake Dermatology Clinical Research Center; 🇺🇸 Austin, Texas, United States

Forefront Dermatology; 🇺🇸 Louisville, Kentucky, United States