To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
92
Baumann Cosmetic & Research Institute
Miami, Florida, United States
FXM Research Corp
Miami, Florida, United States
Augusta Centre for Dermatology and Skin
Augusta, Georgia, United States
Investigator Global Assessment (IGA) Improvement From Baseline
The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe).
Time frame: Baseline to Week 12 / end of treatment
Change in Inflammatory Lesion Counts From Baseline
The LS mean changes from Baseline in inflammatory lesion count at Week 12.
Time frame: Baseline to Week 12 / end of treatment
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Minnesota Clinical Study Center
Fridley, Minnesota, United States
Skin Search of Rochester, Inc
Rochester, New York, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
DermResearch, Inc
Austin, Texas, United States
J & S Studies, Inc
College Station, Texas, United States
Premier Clinical Research
Spokane, Washington, United States
Madison Skin and Research, Inc
Madison, Wisconsin, United States