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Completed

NCT Number: NCT01293552

Clinical Trial To Evaluate ANT-1207 In Subjects With Acne

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

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Total Skin & Beauty Dermatology Center, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANT-1207

Biological

single dose application

Vehicle

Biological

Other names: Placebo

Primary outcomes

  1. Efficacy will be assessed by lesion count.

    Time frame: Week 4

    inflammatory lesion count (papules, pustules, and nodules) and non-inflammatory lesion count (open and closed comedones)

Secondary outcomes

  1. Change from Baseline in Investigator Global Assessment Score

    Time frame: Week 1, 2, 4, 8, and 12

  2. Change from Baseline in Lesion Count

    Time frame: Week 1, 2, 4, 8, 12

Sponsors and collaborators

Lead sponsor

Anterios Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 10, 2011
Registry last updated
Jul 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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