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

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: NCT03655691
• Other study ID #: ET-01-LCL-207
• Status: Completed
• Phase: Phase 2
• Start date: August 16, 2018
• Est. completion date: April 11, 2019

Study information

• Verified date: April 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: 79
• Est. completion date: April 11, 2019
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crow's Feet
• Lateral Canthal Lines

Intervention

Biological:
• Vehicle
Vehicle Formulation
• botulinum toxin, Type A
botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline
• botulinum toxin, Type A
botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline

Locations

Country	Name	City	State
United States	Westlake Dermatology Clinical Research Center	Austin	Texas
United States	Dermatology NOLA Inc.	Metairie	Louisiana
United States	Baumann Cosmetic & Research Institute	Miami	Florida
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Radiant Research, Inc.	Pinellas Park	Florida
United States	Research Institute of the Southeast, LLC	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	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 IGA-C Score = 2 at Any Time Between Week 2 and Week 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.	Week 2, 4, 8,12, and 18
Secondary	Total Number of Observations With a Response Defined as SSA-C Score = 2 at Any Time Between Week 2 and Week 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.	Week 2, 4, 8,12, and 18