Clinical trial NCT02571998: A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris
Official title: A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Multicenter Study to Evaluate the Safety and Efficacy of CLS001 Topical Gel Versus Vehicle Applied Once Daily for 12 Weeks to Female Subjects With Moderate to Severe Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-10-08
Enrollment: 320
Sex: FEMALE
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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Absolute change from baseline in inflammatory lesion counts at week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Absolute change from Baseline at each visit in inflammatory lesions, non-inflammatory lesions, and total lesions
timeFrame: 12 weeks
measure: Percentage of subjects with at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit
timeFrame: 12 weeks
measure: Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) at each visit
timeFrame: 12 weeks
measure: Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) and at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Santa Ana
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Boca Raton
country: United States
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Sanford
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Beverly
country: United States
state: Massachusetts
city: Fort Gratiot
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Newington
country: United States
state: New Hampshire
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: High Point
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Knoxville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Pflugerville
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Webster
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Spokane
country: United States
state: Washington
Study officials:
References: