Clinical Trial To Evaluate ANT-1207 In Subjects With Acne

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Biological: ANT-1207; Biological: Vehicle

• Registration Number: NCT01293552
• Lead Sponsor: Anterios Inc.

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 available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Primary Completion: 2012-04
• Study Completion: 2012-07
• Status Verified: 2013-06
• Disposition First Submitted: 2013-06-21
• Disposition First Submitted QC: 2013-06-21
• Last Update Submitted: 2013-06-28
• Disposition First Posted: 2013-07-01
• Last Update Posted: 2013-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 2	ANT-1207	Dose 2
Dose 4	ANT-1207	Dose 4
Control	Vehicle	blank vehicle formulation
Dose 1	ANT-1207	Dose 1
Dose 3	ANT-1207	Dose 3

Primary Outcome Measures

Name	Time	Method
Efficacy will be assessed by lesion count.	Week 4	inflammatory lesion count (papules, pustules, and nodules) and non-inflammatory lesion count (open and closed comedones)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (15)

International Dermatology Research; 🇺🇸 Miami, Florida, United States

Total Skin & Beauty Dermatology Center; 🇺🇸 Birmingham, Alabama, United States

Palm Beach Esthetic Dermatology and Laser Center; 🇺🇸 West Palm Beach, Florida, United States

William Coleman III, MD, APMC; 🇺🇸 Metairie, Louisiana, United States

Gwinnett Clinical Research Center Inc.; 🇺🇸 Snellville, Georgia, United States

Gramercy Park Dermatology; 🇺🇸 New York, New York, United States

The Dermatology Group, P.C.; 🇺🇸 Verona, New Jersey, United States

Skin Search of Rochester, Inc; 🇺🇸 Rochester, New York, United States

Penn State Hershey Medical Center Department of Dermatology; 🇺🇸 Hershey, Pennsylvania, United States

Yardley Dermatology Associates; 🇺🇸 Yardley, Pennsylvania, United States

DermResearch, Inc.; 🇺🇸 Austin, Texas, United States

Grekin Skin Institute; 🇺🇸 Warren, Michigan, 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