Clinical Trial To Evaluate ANT-1207 In Subjects With Acne

June 28, 2013 updated by: Anterios Inc.

Clinical Trial To Evaluate Botulinum Neurotoxin Type A (ANT-1207) In Subjects With Acne

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Total Skin & Beauty Dermatology Center
    • Florida
      • Miami, Florida, United States, 33144
        • International Dermatology Research
      • West Palm Beach, Florida, United States, 33401
        • Palm Beach Esthetic Dermatology and Laser Center
    • Georgia
      • Snellville, Georgia, United States, 30078
        • Gwinnett Clinical Research Center Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Dermatology Specialists Research, LLC
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • William Coleman III, MD, APMC
    • Michigan
      • Warren, Michigan, United States, 48088
        • Grekin Skin Institute
    • New Jersey
      • Verona, New Jersey, United States, 07044
        • The Dermatology Group, P.C.
    • New York
      • New York, New York, United States, 10010
        • Gramercy Park Dermatology
      • Rochester, New York, United States, 14623
        • Skin Search of Rochester, Inc
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Dermatology Consulting Services
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center Department of Dermatology
      • Yardley, Pennsylvania, United States, 19067
        • Yardley Dermatology Associates
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • The Skin Wellness Center
    • Texas
      • Austin, Texas, United States, 78759
        • Dermresearch, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
blank vehicle formulation
Biological: Vehicle
Other Names:
  • Placebo
Experimental: Dose 1
Biological: ANT-1207
single dose application
Experimental: Dose 2
Biological: ANT-1207
single dose application
Experimental: Dose 3
Biological: ANT-1207
single dose application
Experimental: Dose 4
Biological: ANT-1207
single dose application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy will be assessed by lesion count.
Time Frame: Week 4
inflammatory lesion count (papules, pustules, and nodules) and non-inflammatory lesion count (open and closed comedones)
Week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Investigator Global Assessment Score
Time Frame: Week 1, 2, 4, 8, and 12
Week 1, 2, 4, 8, and 12
Change from Baseline in Lesion Count
Time Frame: Week 1, 2, 4, 8, 12
Week 1, 2, 4, 8, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anterios Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 9, 2011

First Submitted That Met QC Criteria

February 9, 2011

First Posted (Estimate)

February 10, 2011

Study Record Updates

Last Update Posted (Estimate)

July 4, 2013

Last Update Submitted That Met QC Criteria

June 28, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANT-1207-101-ACNE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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