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

Eirion Therapeutics Inc.79 enrolled

Overview

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

This product is being tested for its ability to reduce lateral canthal lines, also known as Crow's Feet.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Lateral Canthal Lines Crow's Feet

Interventions

VehicleBIOLOGICAL

Vehicle Formulation

botulinum toxin, Type ABIOLOGICAL

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

botulinum toxin, Type ABIOLOGICAL

botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (6)

Baumann Cosmetic & Research Institute

Miami, Florida, United States

Radiant Research, Inc.

Pinellas Park, Florida, United States

Research Institute of the Southeast, LLC

West Palm Beach, Florida, United States

Dermatology NOLA Inc.

Metairie, Louisiana, United States

Outcomes

Primary Outcomes

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.

Time frame: Week 4

Secondary Outcomes

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.

Time frame: 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

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.

Time frame: Week 2, 4, 8,12, and 18

Data from ClinicalTrials.gov

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