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

NCT03839693 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ET-01-LCL-208
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 5

Brief Summary

This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).

Conditions

Lateral Canthal Lines; Crow's Feet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Response Defined as Change in SSA-C Score ≥ 2 at Any Time Between Week 4 and Week 12

  Week 4, 8,and 12

Study Arms (3)

Vehicle

PLACEBO COMPARATOR

Vehicle

Biological: Vehicle

ET-01 345U

EXPERIMENTAL

botulinum toxin, Type A, Dose 1, 345 U

Biological: botulinum toxin, Type A

ET-01 1100U

EXPERIMENTAL

botulinum toxin, Type A, Dose 2, 1100 U

Biological: botulinum toxin, Type A

Interventions

botulinum toxin, Type A BIOLOGICAL

topical liniment

Also known as: ET-01

ET-01 1100U; ET-01 345U

Vehicle BIOLOGICAL

Vehicle Formulation

Vehicle

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eirion Therapeutics Inc.: lead

Study Sites (5)

Baumann Cosmetic & Research Institute

Miami, Florida, 33137, United States

Location

Synexus, Inc.

Pinellas Park, Florida, 33781, United States

Location

Forefront Dermatology

Louisville, Kentucky, 40202, United States

Location

Westlake Dermatology Clinical Research Center

Austin, Texas, 78746, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Patrick Murphy
• Organization: Clinical Research Management Group

p.murphy@crmg-usa.com

4138210022

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: sequential cohort, dose escalating study

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 15, 2019
• Study Start: October 16, 2018
• Primary Completion: April 18, 2019
• Study Completion: September 19, 2019
• Last Updated: August 23, 2022
• Results First Posted: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)