Clinical Trial To Evaluate ANT-1207 In Subjects With Acne
This study has been completed.
Sponsor:
Anterios Inc.
Information provided by (Responsible Party):
Anterios Inc.
ClinicalTrials.gov Identifier:
NCT01293552
First received: February 9, 2011
Last updated: January 23, 2013
Last verified: January 2013
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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 |
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 |
Biological: ANT-1207
single dose application
|
|
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: | January 23, 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 May 19, 2013