Clinical Trial to Evaluate ANT-1401 in Crow's Feet

NCT ID: NCT01809964

Last Updated: 2014-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral Canthal Lines.

Detailed Description

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Conditions

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Lateral Canthal Lines Crows Feet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dose 1

ANT-1401

Group Type EXPERIMENTAL

ANT-1401

Intervention Type BIOLOGICAL

Dose 2

ANT-1401

Group Type EXPERIMENTAL

ANT-1401

Intervention Type BIOLOGICAL

Vehicle

Placebo Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type BIOLOGICAL

Interventions

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ANT-1401

Intervention Type BIOLOGICAL

Vehicle

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 30 - 60 years of age
* mild to moderate Crow's Feet wrinkles (IGA 1-2) at rest
* moderate to severe Crow's Feet (IGA 2-3) on contraction
* moderate to severe Crow's Feet (SSA 2-3) on contraction
* Have adequate vision to assess facial wrinkles in a mirror

Exclusion Criteria

* botulinum toxin treatment in the prior 6 months
* history of periocular surgery, brow lift or related procedures
* soft tissue augmentation in the lateral canthal region in the prior 12 months
* dermabrasion or laser treatment in the periocular region in the last 6 months
* topical prescription-strength retinoids in the prior 3 months
* present or history of neuromuscular disease
* present or history of "dry eye"
* systemic aminoglycoside use in the week prior to treatment application
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Anterios Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Birmingham, Alabama, United States

Site Status

Miami, Florida, United States

Site Status

Pinellas Park, Florida, United States

Site Status

West Palm Beach, Florida, United States

Site Status

Louisville, Kentucky, United States

Site Status

Metairie, Louisiana, United States

Site Status

Knoxville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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ANT-1401-LCL-203

Identifier Type: -

Identifier Source: org_study_id

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