Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris

Phase 2

Completed

Brief Summary: 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

Recruitment & Eligibility

Inclusion Criteria

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)

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Vehicle Gel	CLS001 Topical Gel Vehicle	-
CLS001 topical gel 2.5%	CLS001 Topical Gel	Topical application once daily
CLS001 topical gel 1.75%	CLS001 Topical Gel	Topical application once daily
CLS001 topical gel 1%	CLS001 Topical Gel	Topical application once daily

Primary Outcome Measures

Name	Time	Method
Change in inflammatory lesion count from Baseline	6, 9 and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline at each visit in inflammatory lesions, non-inflammatory lesions and total lesions	1, 3, 6, 9 and 12 weeks
Absolute change from Baseline at each visit in inflammatory lesions, no-inflammatory lesions, and total lesions	1, 3, 6, 9 and 12 weeks
Percentage of subjects with an Investigator's Global Assessment (IGA) of clear or almost clear (0 or 1) at each visit	1, 3, 6, 9, and 12 weeks
Percentage of subjects with a 2 grade reduction in the IGA at each visit	1, 3, 6, 9, and 12 weeks

Locations (20): Skin Surgery Medical Group, Inc.
🇺🇸
San Diego, California, United States
Skin Care Research, Inc.
🇺🇸
Boca Raton, Florida, United States
Moore Clinical Research, Inc.
🇺🇸
Tampa, Florida, United States
Clinical Science Institute
🇺🇸
Santa Monica, California, United States
Belleair Research Center
🇺🇸
Pinellas Park, Florida, United States
Manhattan Dermatology & Cosmetic Center
🇺🇸
New York, New York, United States
Dermatology Consulting Services
🇺🇸
High Point, North Carolina, United States
Wake Research Associates
🇺🇸
Raleigh, North Carolina, United States
Premier Research
🇺🇸
Austin, Texas, United States
Progressive Clinical Research, PA
🇺🇸
San Antonio, Texas, United States
Tennessee Clinical Research Center
🇺🇸
Nashville, Tennessee, United States
Encino Research Center
🇺🇸
Encino, California, United States
MedaPhase, Inc.
🇺🇸
Newnan, Georgia, United States
Hamzavi Dermatology
🇺🇸
Fort Gratiot, Michigan, United States
Kenneth R. Beer, MD, PA
🇺🇸
West Palm Beach, Florida, United States
Premier Clinical Research
🇺🇸
Spokane, Washington, United States
J & S Studies, Inc.
🇺🇸
College Station, Texas, United States
Academic Dermatology Associates
🇺🇸
Albuquerque, New Mexico, United States
Derm Research Center of New York, Inc.
🇺🇸
Stony Brook, New York, United States
Minnesota Clinical Study Center
🇺🇸
Fridley, Minnesota, United States