Clinical trial NCT02066545: Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris
Official title: A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-02-19
Enrollment: 327
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in inflammatory lesion count from Baseline
timeFrame: 6, 9 and 12 weeks
Secondary outcomes:
measure: Percent change from baseline at each visit in inflammatory lesions, non-inflammatory lesions and total lesions
timeFrame: 1, 3, 6, 9 and 12 weeks
measure: Absolute change from Baseline at each visit in inflammatory lesions, no-inflammatory lesions, and total lesions
timeFrame: 1, 3, 6, 9 and 12 weeks
measure: Percentage of subjects with an Investigator's Global Assessment (IGA) of clear or almost clear (0 or 1) at each visit
timeFrame: 1, 3, 6, 9, and 12 weeks
measure: Percentage of subjects with a 2 grade reduction in the IGA at each visit
timeFrame: 1, 3, 6, 9, and 12 weeks
Other outcomes:
Locations:
city: Encino
country: United States
facility: Encino Research Center
state: California
city: San Diego
country: United States
facility: Skin Surgery Medical Group, Inc.
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Boca Raton
country: United States
facility: Skin Care Research, Inc.
state: Florida
city: Pinellas Park
country: United States
facility: Belleair Research Center
state: Florida
city: Tampa
country: United States
facility: Moore Clinical Research, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Kenneth R. Beer, MD, PA
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: New York
country: United States
facility: Manhattan Dermatology & Cosmetic Center
state: New York
city: Stony Brook
country: United States
facility: Derm Research Center of New York, Inc.
state: New York
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: Premier Research
state: Texas
city: College Station
country: United States
facility: J & S Studies, Inc.
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
References: