Clinical Trial To Evaluate ANT-1207 In Subjects With Acne
Clinical Trial To Evaluate Botulinum Neurotoxin Type A (ANT-1207) In Subjects With Acne
1 other identifier
interventional
72
1 country
15
Brief Summary
The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of acne.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2011
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 9, 2011
CompletedFirst Posted
Study publicly available on registry
February 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJuly 4, 2013
June 1, 2013
1.2 years
February 9, 2011
June 28, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy will be assessed by lesion count.
inflammatory lesion count (papules, pustules, and nodules) and non-inflammatory lesion count (open and closed comedones)
Week 4
Secondary Outcomes (2)
Change from Baseline in Investigator Global Assessment Score
Week 1, 2, 4, 8, and 12
Change from Baseline in Lesion Count
Week 1, 2, 4, 8, 12
Study Arms (5)
Control
PLACEBO COMPARATORblank vehicle formulation
Dose 1
EXPERIMENTALDose 1
Dose 2
EXPERIMENTALDose 2
Dose 3
EXPERIMENTALDose 3
Dose 4
EXPERIMENTALDose 4
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of moderate to severe facial acne
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anterios Inc.lead
Study Sites (15)
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, 35205, United States
International Dermatology Research
Miami, Florida, 33144, United States
Palm Beach Esthetic Dermatology and Laser Center
West Palm Beach, Florida, 33401, United States
Gwinnett Clinical Research Center Inc.
Snellville, Georgia, 30078, United States
Dermatology Specialists Research, LLC
Louisville, Kentucky, 40202, United States
William Coleman III, MD, APMC
Metairie, Louisiana, 70006, United States
Grekin Skin Institute
Warren, Michigan, 48088, United States
The Dermatology Group, P.C.
Verona, New Jersey, 07044, United States
Gramercy Park Dermatology
New York, New York, 10010, United States
Skin Search of Rochester, Inc
Rochester, New York, 14623, United States
Dermatology Consulting Services
High Point, North Carolina, 27262, United States
Penn State Hershey Medical Center Department of Dermatology
Hershey, Pennsylvania, 17033, United States
Yardley Dermatology Associates
Yardley, Pennsylvania, 19067, United States
The Skin Wellness Center
Knoxville, Tennessee, 37922, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2011
First Posted
February 10, 2011
Study Start
January 1, 2011
Primary Completion
April 1, 2012
Study Completion
July 1, 2012
Last Updated
July 4, 2013
Record last verified: 2013-06