ET-01 in Subjects With Lateral Canthal Lines, LCL-207

Phase 2

Completed

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

• Registration Number: NCT03655691
• 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: 2018-08-16
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-08-30
• Study First Posted: 2018-08-31
• Primary Completion: 2018-11-09
• Study Completion: 2019-04-11
• Disposition First Submitted: 2020-01-27
• Disposition First Submitted QC: 2020-02-04
• Disposition First Posted: 2020-02-10
• Results First Submitted: 2022-01-26
• Results First Submitted QC: 2022-01-26
• Results First Posted: 2022-02-18
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• 25 - 65 years of age
• minimal to moderate Crow's Feet wrinkles at rest
• moderate to severe Crow's Feet wrinkles on contraction
• willingness to refrain from any product affecting skin remodeling
• female subjects must be not pregnant and non-lactating

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Vehicle / Placebo formulation
Dose 2	botulinum toxin, Type A	higher dose of ET-01
Dose 1	botulinum toxin, Type A	lower dose of ET-01

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 SSA-C Score ≤ 2 at Any Time Between Week 2 and Week 18	Week 2, 4, 8,12, and 18	Total number of observations with a Score of ≤ 2 on 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 Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18.
Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 at Any Time Between Week 2 and Week 18	Week 2, 4, 8,12, and 18	Total number of observations with a Score of ≤ 2 on the Investigators Global Assessment on Contraction, IGA-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 Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18.

Trial Locations

Locations (6)

Radiant Research, Inc.; 🇺🇸 Pinellas Park, Florida, United States

Dermatology NOLA Inc.; 🇺🇸 Metairie, Louisiana, United States

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

Research Institute of the Southeast, LLC; 🇺🇸 West Palm Beach, Florida, United States

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

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