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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-16

Study Completion Date

2019-09-19

Brief Summary

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

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Detailed Description

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

Conditions

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Lateral Canthal Lines Crow's Feet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

sequential cohort, dose escalating study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type BIOLOGICAL

Vehicle Formulation

ET-01 345U

botulinum toxin, Type A, Dose 1, 345 U

Group Type EXPERIMENTAL

botulinum toxin, Type A

Intervention Type BIOLOGICAL

topical liniment

ET-01 1100U

botulinum toxin, Type A, Dose 2, 1100 U

Group Type EXPERIMENTAL

botulinum toxin, Type A

Intervention Type BIOLOGICAL

topical liniment

Interventions

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botulinum toxin, Type A

topical liniment

Intervention Type BIOLOGICAL

Vehicle

Vehicle Formulation

Intervention Type BIOLOGICAL

Other Intervention Names

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ET-01

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No