Clinical Trial To Evaluate ANT-1207 In Subjects With Acne

Acne Vulgaris Clinical Trial

Official title:

Clinical Trial To Evaluate Botulinum Neurotoxin Type A (ANT-1207) In Subjects With Acne

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293552
• Other study ID #: ANT-1207-101-ACNE
• Status: Completed
• Phase: Phase 2
• First received: February 9, 2011
• Last updated: June 28, 2013
• Start date: January 2011
• Est. completion date: July 2012

Study information

• Verified date: June 2013
• Source: Anterios Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of acne.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Biological:
• ANT-1207
single dose application
• Vehicle

Locations

Country	Name	City	State
United States	DermResearch, Inc.	Austin	Texas
United States	Total Skin & Beauty Dermatology Center	Birmingham	Alabama
United States	Penn State Hershey Medical Center Department of Dermatology	Hershey	Pennsylvania
United States	Dermatology Consulting Services	High Point	North Carolina
United States	The Skin Wellness Center	Knoxville	Tennessee
United States	Dermatology Specialists Research, LLC	Louisville	Kentucky
United States	William Coleman III, MD, APMC	Metairie	Louisiana
United States	International Dermatology Research	Miami	Florida
United States	Gramercy Park Dermatology	New York	New York
United States	Skin Search of Rochester, Inc	Rochester	New York
United States	Gwinnett Clinical Research Center Inc.	Snellville	Georgia
United States	The Dermatology Group, P.C.	Verona	New Jersey
United States	Grekin Skin Institute	Warren	Michigan
United States	Palm Beach Esthetic Dermatology and Laser Center	West Palm Beach	Florida
United States	Yardley Dermatology Associates	Yardley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Anterios Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from Baseline in Investigator Global Assessment Score		Week 1, 2, 4, 8, and 12	No
Secondary	Change from Baseline in Lesion Count		Week 1, 2, 4, 8, 12	No