Clinical Trial To Evaluate ANT-1207 In Subjects With Acne

NCT ID: NCT01293552

Last Updated: 2013-07-04

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-07-31

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 acne.

Detailed Description

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Conditions

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Acne Vulgaris

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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Control

blank vehicle formulation

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type BIOLOGICAL

Dose 1

Dose 1

Group Type EXPERIMENTAL

ANT-1207

Intervention Type BIOLOGICAL

single dose application

Dose 2

Dose 2

Group Type EXPERIMENTAL

ANT-1207

Intervention Type BIOLOGICAL

single dose application

Dose 3

Dose 3

Group Type EXPERIMENTAL

ANT-1207

Intervention Type BIOLOGICAL

single dose application

Dose 4

Dose 4

Group Type EXPERIMENTAL

ANT-1207

Intervention Type BIOLOGICAL

single dose application

Interventions

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ANT-1207

single dose application

Intervention Type BIOLOGICAL

Vehicle

Intervention Type BIOLOGICAL

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

* diagnosis of moderate to severe facial acne
* 15 to 40 papules and pustules, and 5 to 50 open and/or closed comedones
* no presence of nodules
* female subjects must be not pregnant and non-lactating

Exclusion Criteria

* presence of 1 or more nodules
* use of topical steroids on the face 4 weeks prior and during the study
* use of systemic corticosteroids 6 weeks prior and during the study
* topical or systemic acne treatment in the 4 weeks prior to Baseline
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

International Dermatology Research

Miami, Florida, United States

Site Status

Palm Beach Esthetic Dermatology and Laser Center

West Palm Beach, Florida, United States

Site Status

Gwinnett Clinical Research Center Inc.

Snellville, Georgia, United States

Site Status

Dermatology Specialists Research, LLC

Louisville, Kentucky, United States

Site Status

William Coleman III, MD, APMC

Metairie, Louisiana, United States

Site Status

Grekin Skin Institute

Warren, Michigan, United States

Site Status

The Dermatology Group, P.C.

Verona, New Jersey, United States

Site Status

Gramercy Park Dermatology

New York, New York, United States

Site Status

Skin Search of Rochester, Inc

Rochester, New York, United States

Site Status

Dermatology Consulting Services

High Point, North Carolina, United States

Site Status

Penn State Hershey Medical Center Department of Dermatology

Hershey, Pennsylvania, United States

Site Status

Yardley Dermatology Associates

Yardley, Pennsylvania, United States

Site Status

The Skin Wellness Center

Knoxville, Tennessee, United States

Site Status

DermResearch, Inc.

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ANT-1207-101-ACNE

Identifier Type: -

Identifier Source: org_study_id

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