A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris

Completed · Phase 2

Conditions studied: Acne Vulgaris

In brief

The primary objective of this study is to evaluate the safety and efficacy of Omiganan (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in female subjects with moderate to severe inflammatory acne vulgaris.

Key facts

Study ID

NCT02571998

Run by

Maruho Co., Ltd.

People needed

320

Starts

2015-10-01

Expected to finish

2016-08-01

Last updated by the study team

2017-03-27

Who can join

Age: 12 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Non-pregnant female subjects ≥ 12 years of age with facial acne vulgaris
• Subjects with an Investigator's Global Assessment (IGA) of Inflammatory Lesions of Acne Vulgaris of Moderate (3) or Severe (4) at Baseline.
• Subjects with ≥ 30 facial inflammatory lesions

You may not qualify if…

• Subjects with < 10 or > 75 facial non-inflammatory lesions
• Subjects with > 3 facial nodular or cystic lesions at Baseline
• Standard exclusion criteria

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Santa Ana, California, United States
• Study site — Santa Monica, California, United States
• Study site — Denver, Colorado, United States
• Study site — Boca Raton, Florida, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — Sanford, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Beverly, Massachusetts, United States
• Study site — Fort Gratiot, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Newington, New Hampshire, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Stony Brook, New York, United States
• Study site — High Point, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Knoxville, Tennessee, United States
• Study site — Arlington, Texas, United States
• Study site — Austin, Texas, United States
• Study site — Pflugerville, Texas, United States

Full record on ClinicalTrials.gov

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