Clinical trial NCT02576860: Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
Official title: A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With a 4 Week Follow-up Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rosacea
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-10-15
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.


Eligibility criteria: Inclusion Criteria:

1. Healthy, male and non-pregnant female subjects, 18 years of age or older.
2. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.
3. Subjects with the presence of telangiectasia at Baseline.
4. Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline.
5. Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.

Exclusion Criteria:

1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
2. Subjects with nodular rosacea.
3. Standard exclusion criteria.

Primary outcomes:
measure: Efficacy Absolute Change in Inflammatory Lesion Count
timeFrame: 12 weeks
measure: Efficacy IGA: 2 Grade Reduction
timeFrame: 12 weeks
Secondary outcomes:
measure: Efficacy The Absolute Change in Inflammatory Lesions
timeFrame: 9 weeks
measure: Efficacy The Absolute Change in Inflammatory Lesions
timeFrame: 6 weeks
measure: Efficacy IGA: 2 Point Reduction
timeFrame: 9 Weeks
measure: Efficacy IGA: 2 Point Reduction
timeFrame: 6 Weeks
Other outcomes:
measure: Safety Adverse Events
timeFrame: 12 weeks
Locations:
city: Fort Smith
country: United States
state: Arkansas
city: Rogers
country: United States
state: Arkansas
city: Manhattan Beach
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Boynton Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Plainfield
country: United States
state: Indiana
city: Watertown
country: United States
state: Massachusetts
city: Omaha
country: United States
state: Nebraska
city: Verona
country: United States
state: New Jersey
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: Winston-Salem
country: United States
state: North Carolina
city: Fort Washington
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Arlington
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Phillip
country: Australia
state: Australian Capital Territory
city: Kogarah
country: Australia
state: New South Wales
city: Liverpool
country: Australia
state: New South Wales
city: Box Hill
country: Australia
state: Victoria
city: Surrey
country: Canada
state: British Columbia
city: Courtice
country: Canada
state: Ontario
city: Peterborough
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Grenoble
country: France
city: Nantes
country: France
city: Quimper
country: France
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Bonn
country: Germany
city: Friedrichshafen
country: Germany
city: Hamburg
country: Germany
city: Koeln
country: Germany
city: Lingen
country: Germany
city: Monchengladbach
country: Germany
city: Osnabruck
country: Germany
city: Schweinfurt
country: Germany
city: Nijmegen
country: Netherlands
city: Auckland
country: New Zealand
city: Halmstad
country: Sweden
city: Bradford
country: United Kingdom
state: England
city: Birmingham
country: United Kingdom
city: London
country: United Kingdom
Study officials:
References: