Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory 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 once-daily topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel in subjects with inflammatory acne vulgaris

Key facts

Study ID

NCT02066545

Run by

Maruho Co., Ltd.

People needed

327

Starts

2014-04-01

Last updated by the study team

2015-09-17

Who can join

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

You may qualify if…

• Male or non-pregnant female subjects with facial acne vulgaris, 12 years of age or older.
• Subjects with ≥20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules.
• An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4)

You may not qualify if…

• Subjects with acne conglobate, acne fulminans, and secondary acne (chloracne, drug-induced acne, polycystic ovarian syndrome, etc.)
• Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)
• Subjects with more than 2 facial nodulocystic lesions

Where it is running

• Encino Research Center — Encino, California, United States
• Skin Surgery Medical Group, Inc. — San Diego, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Skin Care Research, Inc. — Boca Raton, Florida, United States
• Belleair Research Center — Pinellas Park, Florida, United States
• Moore Clinical Research, Inc. — Tampa, Florida, United States
• Kenneth R. Beer, MD, PA — West Palm Beach, Florida, United States
• MedaPhase, Inc. — Newnan, Georgia, United States
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Manhattan Dermatology & Cosmetic Center — New York, New York, United States
• Derm Research Center of New York, Inc. — Stony Brook, New York, United States
• Dermatology Consulting Services — High Point, North Carolina, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States
• Premier Research — Austin, Texas, United States
• J & S Studies, Inc. — College Station, Texas, United States
• Progressive Clinical Research, PA — San Antonio, Texas, United States
• Premier Clinical Research — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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