Clinical Trial To Evaluate ANT-1207 In Subjects With Crow's Feet

NCT ID: NCT01358695

Last Updated: 2013-07-01

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

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of Crow's Feet.

Detailed Description

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Conditions

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Lateral Canthal Lines Crow's Feet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Comparator

Group Type PLACEBO_COMPARATOR

ANT-1207

Intervention Type BIOLOGICAL

The interventions differ by dose of investigational product applied.

Botulinum Toxin Type A

Intervention Type BIOLOGICAL

The interventions differ by dose of investigational product applied.

Dose 1

Dose 1

Group Type EXPERIMENTAL

ANT-1207

Intervention Type BIOLOGICAL

The interventions differ by dose of investigational product applied.

Botulinum Toxin, Type A

Intervention Type BIOLOGICAL

The interventions differ by dose of investigational product applied.

Botulinum Toxin Type A

Intervention Type BIOLOGICAL

The interventions differ by dose of investigational product applied.

Dose 2

Dose 2

Group Type EXPERIMENTAL

ANT-1207

Intervention Type BIOLOGICAL

The interventions differ by dose of investigational product applied.

Botulinum Toxin, Type A

Intervention Type BIOLOGICAL

The interventions differ by dose of investigational product applied.

Botulinum Toxin Type A

Intervention Type BIOLOGICAL

The interventions differ by dose of investigational product applied.

Dose 3

Dose 3

Group Type EXPERIMENTAL

ANT-1207

Intervention Type BIOLOGICAL

The interventions differ by dose of investigational product applied.

Botulinum Toxin, Type A

Intervention Type BIOLOGICAL

The interventions differ by dose of investigational product applied.

Botulinum Toxin Type A

Intervention Type BIOLOGICAL

The interventions differ by dose of investigational product applied.

Dose 4

Dose 4

Group Type EXPERIMENTAL

Botulinum Toxin, Type A

Intervention Type BIOLOGICAL

The interventions differ by dose of investigational product applied.

Botulinum Toxin Type A

Intervention Type BIOLOGICAL

The interventions differ by dose of investigational product applied.

Dose 5

Dose 5

Group Type EXPERIMENTAL

Botulinum Toxin, Type A

Intervention Type BIOLOGICAL

The interventions differ by dose of investigational product applied.

Botulinum Toxin Type A

Intervention Type BIOLOGICAL

The interventions differ by dose of investigational product applied.

Interventions

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ANT-1207

The interventions differ by dose of investigational product applied.

Intervention Type BIOLOGICAL

Botulinum Toxin, Type A

The interventions differ by dose of investigational product applied.

Intervention Type BIOLOGICAL

Botulinum Toxin Type A

The interventions differ by dose of investigational product applied.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* mild to moderate Crow's Feet wrinkles (IGA 2-3) at rest
* moderate to severe Crow's Feet (IGA 3-4) on contraction
* willingness to refrain from any product affecting skin remodeling
* female subjects must be not pregnant and non-lactating

Exclusion Criteria

* 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

30 Years

Maximum Eligible Age

70 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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Total Skin & Beauty Dermatology Center

Birmingham, Alabama, United States

Site Status

Baumann Cosmetic & Research Institute

Miami Beach, Florida, United States

Site Status

Palm Beach Esthetic Dermatology and Laser Center

West Palm Beach, Florida, United States

Site Status

William Coleman III, MD, APMC

Metairie, Louisiana, United States

Site Status

Gramercy Park Dermatology

New York, New York, United States

Site Status

Cary Skin Care

Cary, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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ANT-1207-201-LCL

Identifier Type: -

Identifier Source: org_study_id

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