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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
263
Topical gel
Vehicle gel
Efficacy Absolute Change in Inflammatory Lesion Count
Absolute change in inflammatory lesion count from baseline to Week 12.
Time frame: 12 weeks
Efficacy IGA: 2 Grade Reduction
Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Time frame: 12 weeks
Efficacy The Absolute Change in Inflammatory Lesions
The absolute change in inflammatory lesions from baseline to Week 9.
Time frame: 9 weeks
Efficacy The Absolute Change in Inflammatory Lesions
The absolute change in inflammatory lesions from baseline to Week 6.
Time frame: 6 weeks
Efficacy IGA: 2 Point Reduction
Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Time frame: 9 Weeks
Efficacy IGA: 2 Point Reduction
Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Time frame: 6 Weeks
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Unnamed facility
Fort Smith, Arkansas, United States
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Rogers, Arkansas, United States
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Manhattan Beach, California, United States
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Oceanside, California, United States
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Washington D.C., District of Columbia, United States
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Boynton Beach, Florida, United States
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Miami, Florida, United States
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Plainfield, Indiana, United States
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Watertown, Massachusetts, United States
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Omaha, Nebraska, United States
...and 37 more locations