Clinical trial NCT02547441: 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 a Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With an Open-Label Safety Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rosacea
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 463
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: Change in Inflammatory Lesion Count From Baseline to Week 12
timeFrame: 12 weeks
measure: Percentage of Participants Who Achieved 2 Grade IGA Reduction.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in the Number of Inflammatory Lesions From Baseline at Week 9
timeFrame: 9 weeks
measure: Change in the Number of Inflammatory Lesions From Baseline at Week 6
timeFrame: 6 weeks
measure: Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.
timeFrame: 9 Weeks
measure: Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6.
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Fremont
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Miramar
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Arlington Heights
country: United States
state: Illinois
city: Carmel
country: United States
state: Indiana
city: Fort Gratiot
country: United States
state: Michigan
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: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Woolloongabba
country: Australia
state: Queensland
city: Carlton
country: Australia
state: Victoria
city: East Melbourne
country: Australia
state: Victoria
city: Hamilton
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Brest
country: France
city: Nancy
country: France
city: Nice
country: France
city: Rouen
country: France
city: Thionville
country: France
city: Augsburg
country: Germany
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Darmstadt
country: Germany
city: Dresden
country: Germany
city: Dulmen
country: Germany
city: Frankfurt
country: Germany
city: Ibbenbueren
country: Germany
city: Lubeck
country: Germany
city: Mahlow
country: Germany
city: Munster
country: Germany
city: Rotterdam
country: Netherlands
city: Hamilton
country: New Zealand
city: Gothenburg
country: Sweden
city: Lanarkshire
country: United Kingdom
city: Leeds
country: United Kingdom
city: Manchester
country: United Kingdom
city: Surrey
country: United Kingdom
Study officials:
References: