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

NCT03655691 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ET-01-LCL-207
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 6

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 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 Response Defined as SSA-C Score ≤ 2 at Any Time Between Week 2 and Week 18

  Week 2, 4, 8,12, and 18

Study Arms (3)

Vehicle

PLACEBO COMPARATOR

Vehicle / Placebo formulation

Biological: Vehicle

Dose 1

EXPERIMENTAL

lower dose of ET-01

Biological: botulinum toxin, Type A

Dose 2

EXPERIMENTAL

higher dose of ET-01

Biological: botulinum toxin, Type A

Interventions

Vehicle BIOLOGICAL

Vehicle Formulation

Vehicle

botulinum toxin, Type A BIOLOGICAL

botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline

Also known as: ET-01

Dose 1

Eligibility Criteria

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

You may qualify if:

• 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

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 (6)

Baumann Cosmetic & Research Institute

Miami, Florida, 33137, United States

Location

Radiant Research, Inc.

Pinellas Park, Florida, 33781, United States

Location

Research Institute of the Southeast, LLC

West Palm Beach, Florida, 33401, United States

Location

Dermatology NOLA Inc.

Metairie, Louisiana, 70006, 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: Chief Executive Officer
• Organization: Eirion Therapeutics

info@eirionthera.com

(781) 935-1216

Study Officials

• Klaus Theobald, MD, PhD

  Eirion Therapeutics

  STUDY DIRECTOR

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
• Masking Details: different doses are packaged in identical containers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: parallel dose groups

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: August 31, 2018
• Study Start: August 16, 2018
• Primary Completion: November 9, 2018
• Study Completion: April 11, 2019
• Last Updated: April 21, 2022
• Results First Posted: February 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)