The objective of this study is to demonstrate that metronidazole 1% topical gel is effective for the treatment of patients with moderate to severe rosacea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
602
Metronidazole Topical Gel 1% applied to affected area once a day for 70 days
Metronidazole Topical Gel 1% applied to affected area once a day for 70 days
Placebo applied to affected area once a day for 70 days
Investigator Site
Phoenix, Arizona, United States
Investigator Site
Long Beach, California, United States
Clinical Success
A patient is considered a clinical success if the IGE is 0 (Clear)or 1 (Almost Clear)
Time frame: Day 70
Treatment Success
A patient is considered a treatment success if the mean percent change from baseline at week 10 (Day 70) in the inflammatory (papules and pastales) lesion count of Rosacea
Time frame: Day 70
Change in Investigational Global Evaluation (IGE)
Mean change from baseline to end of treatment in IGE
Time frame: Day 70
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Investigator Site
Newport Beach, California, United States
Investigator Site
Denver, Colorado, United States
Investigator Site
Jacksonville, Florida, United States
Investigator Site
Miami, Florida, United States
Investigator Site
Miramar, Florida, United States
Investigator Site
Arlington Heights, Illinois, United States
Investigator Site
Plainfield, Indiana, United States
Investigator Site
Henderson, Nevada, United States
...and 12 more locations