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Clinical Trial To Evaluate ANT-1207 In Subjects With Acne

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01293552
First Posted: February 10, 2011
Last Update Posted: July 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anterios Inc.
  Purpose
The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of acne.

Condition Intervention Phase
Acne Vulgaris Biological: ANT-1207 Biological: Vehicle Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial To Evaluate Botulinum Neurotoxin Type A (ANT-1207) In Subjects With Acne

Resource links provided by NLM:


Further study details as provided by Anterios Inc.:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Change from Baseline in Investigator Global Assessment Score [ Time Frame: Week 1, 2, 4, 8, and 12 ]
  • Change from Baseline in Lesion Count [ Time Frame: Week 1, 2, 4, 8, 12 ]

Enrollment: 72
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
blank vehicle formulation
Biological: Vehicle
Other Name: Placebo
Experimental: Dose 1
Dose 1
Biological: ANT-1207
single dose application
Experimental: Dose 2
Dose 2
Biological: ANT-1207
single dose application
Experimental: Dose 3
Dose 3
Biological: ANT-1207
single dose application
Experimental: Dose 4
Dose 4
Biological: ANT-1207
single dose application

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293552


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

Responsible Party: Anterios Inc.
ClinicalTrials.gov Identifier: NCT01293552     History of Changes
Other Study ID Numbers: ANT-1207-101-ACNE
First Submitted: February 9, 2011
First Posted: February 10, 2011
Last Update Posted: July 4, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases