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: January 23, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 9, 2011
Last Updated Date	January 23, 2013
Start Date ^ICMJE	January 2011
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 9, 2011)	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)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01293552 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 9, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Trial To Evaluate ANT-1207 In Subjects With Acne
Official Title ^ICMJE	Clinical Trial To Evaluate Botulinum Neurotoxin Type A (ANT-1207) In Subjects With Acne
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Acne Vulgaris
Intervention ^ICMJE	Biological: ANT-1207 single dose application
Study Arm (s)	Placebo Comparator: Control Intervention: Biological: ANT-1207 Experimental: Dose 1 Dose 1 Intervention: Biological: ANT-1207 Experimental: Dose 2 Dose 2 Intervention: Biological: ANT-1207 Experimental: Dose 3 Dose 3 Intervention: Biological: ANT-1207 Experimental: Dose 4 Dose 4 Intervention: Biological: ANT-1207
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	72
Completion Date	July 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01293552
Other Study ID Numbers ^ICMJE	ANT-1207-101-ACNE
Has Data Monitoring Committee	Yes
Responsible Party	Anterios Inc.
Study Sponsor ^ICMJE	Anterios Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Anterios Inc.
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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