ET-01 in Subjects With Lateral Canthal Lines, LCL-209

Eirion Therapeutics Inc.38 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 (LCL), also known as Crow's Feet.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Lateral Canthal Lines, LCL Crow's Feet

Interventions

botulinum toxin, Type ABIOLOGICAL

topical liniment

VehicleBIOLOGICAL

Vehicle Formulation

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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 (3)

Synexis, Inc.

Pinellas Park, Florida, United States

Yardley Dermatology Associates

Yardley, Pennsylvania, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, 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 Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit

Total number of observations with a change in the Investigators Global Assessment on Contraction, IGA-C, and 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 a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26.

Time frame: 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 Post Baseline Visit

Total number of observations with a change in 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 a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26.

Time frame: Week 1, 2, 4, 8,12,18, and 26

Data from ClinicalTrials.gov

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