ET-01 in Subjects With Lateral Canthal Lines

Phase 2

Completed

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

• Registration Number: NCT03326856
• 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: 2017-10-25
• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-10-31
• Primary Completion: 2018-06-11
• Study Completion: 2018-11-14
• Disposition First Submitted: 2019-07-01
• Results First Submitted: 2021-06-29
• Results First Submitted QC: 2021-08-15
• Disposition First Submitted QC: 2021-08-15
• Results First Posted: 2021-09-10
• Disposition First Posted: 2021-09-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Vehicle
Dose 4	botulinum toxin, Type A	botulinum toxin, Type A, Dose 4
Dose 2	botulinum toxin, Type A	botulinum toxin, Type A, Dose 2
Dose 3	botulinum toxin, Type A	botulinum toxin, Type A, Dose 3
Dose 1	botulinum toxin, Type A	botulinum toxin, Type A, Dose 1

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2	Week 4	Composite of Investigators Global Assessment \& Subject Self-Assessment on contraction.; Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). The same scale is used for the Investigator's Assessment as well as the Subject's Self Assessment. To count, both assessments (on contraction) have to be "responders" defined as Score ≤ 2.

Secondary Outcome Measures

Name	Time	Method
Total Number of Observations With a Response Defined as IGA-C Score ≤ 2	Week 2, 4, 8,12,18	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.
Total Number of Observations With a Response Defined as SSA-C Score ≤ 2	Week 2, 4, 8,12,18	Total number of observations with a Score of ≤ 2 on 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 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 (1)

Cary Skin Care; 🇺🇸 Cary, North Carolina, United States