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

Lateral Canthal Lines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839693
• Other study ID #: ET-01-LCL-208
• Status: Completed
• Phase: Phase 2
• Start date: October 16, 2018
• Est. completion date: September 19, 2019

Study information

• Verified date: July 2022
• 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, also known as Crow's Feet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 19, 2019
• Est. primary completion date: April 18, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crow's Feet
• Lateral Canthal Lines

Intervention

Biological:
• botulinum toxin, Type A
topical liniment
• Vehicle
Vehicle Formulation

Locations

Country	Name	City	State
United States	Westlake Dermatology Clinical Research Center	Austin	Texas
United States	Forefront Dermatology	Louisville	Kentucky
United States	Baumann Cosmetic & Research Institute	Miami	Florida
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Synexus, Inc.	Pinellas Park	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	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	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.	Week 4
Secondary	Total Number of Observations With a Response Defined as Change =2 in IGA-C and SSA-C Score at Any Post Baseline Visit	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.	Week 1, 2, 4, 8,12,18, and 26
Secondary	Total Number of Observations With a Response Defined as Change in SSA-C Score = 2 at Any Time Between Week 4 and Week 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.	Week 4, 8,and 12