Clinical Trial To Evaluate ANT-1207 In Subjects With Acne

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anterios Inc.
ClinicalTrials.gov Identifier:
NCT01293552
First received: February 9, 2011
Last updated: June 28, 2013
Last verified: June 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change from Baseline in Lesion Count [ Time Frame: Week 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Anterios Inc.
ClinicalTrials.gov Identifier: NCT01293552     History of Changes
Other Study ID Numbers: ANT-1207-101-ACNE
Study First Received: February 9, 2011
Last Updated: June 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014