Dose Finding Study In Subjects With Crow's Feet

NCT ID: NCT01951742

Last Updated: 2014-05-29

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

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-01-31

Brief Summary

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The purpose of this study is to establish the therapeutic range of ANT-1401 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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vehicle

vehicle without ANT-1401

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type BIOLOGICAL

Vehicle

Dose 1

lowest dose

Group Type EXPERIMENTAL

ANT-1401

Intervention Type BIOLOGICAL

Active

Dose 2

second lowest dose

Group Type EXPERIMENTAL

ANT-1401

Intervention Type BIOLOGICAL

Active

Dose 3

mid-level dose

Group Type EXPERIMENTAL

ANT-1401

Intervention Type BIOLOGICAL

Active

Dose 4

second highest dose

Group Type EXPERIMENTAL

ANT-1401

Intervention Type BIOLOGICAL

Active

Dose 5

highest dose

Group Type EXPERIMENTAL

ANT-1401

Intervention Type BIOLOGICAL

Active

Interventions

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ANT-1401

Active

Intervention Type BIOLOGICAL

Vehicle

Vehicle

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 30 - 60 years of age
* mild 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 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

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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Miami, Florida, United States

Site Status

Pinellas Park, Florida, United States

Site Status

West Palm Beach, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

Metairie, Louisiana, United States

Site Status

New Orleans, Louisiana, United States

Site Status

Rochester, New York, United States

Site Status

High Point, North Carolina, United States

Site Status

Knoxville, Tennessee, United States

Site Status

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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ANT-1401-LCL-204

Identifier Type: -

Identifier Source: org_study_id

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