ET-01 in Subjects With Lateral Canthal Lines

Eirion Therapeutics Inc.48 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

botulinum toxin, Type ABIOLOGICAL

topical liniment

VehicleBIOLOGICAL

Vehicle Formulation

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 (1)

Cary Skin Care

Cary, North Carolina, United States

Outcomes

Primary Outcomes

Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2

Composite of Investigators Global Assessment \& Subject Self-Assessment on contraction. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). The same scale is used for the Investigator's Assessment as well as the Subject's Self Assessment. To count, both assessments (on contraction) have to be "responders" defined as Score ≤ 2.

Time frame: Week 4

Secondary Outcomes

Total Number of Observations With a Response Defined as IGA-C Score ≤ 2

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, 8,12,18

Total Number of Observations With a Response Defined as SSA-C Score ≤ 2

Total number of observations with a Score of ≤ 2 on 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 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, 8,12,18

Data from ClinicalTrials.gov

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