The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
107
Dermata Investigational Site
San Diego, California, United States
Dermata Investigational Site
Miami, Florida, United States
Dermata Investigational Site
Fridley, Minnesota, United States
Dermata Investigational Site
Efficacy as measured by Inflammatory lesion counts
Inflammatory lesion counts
Time frame: 12 weeks
Efficacy as measured by Investigator Global Assessment (IGA)
Investigator Global Assessment (IGA)
Time frame: 12 weeks
Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)
5-point Clinical Erythema Assessment (CEA)
Time frame: 12 weeks
Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)
5-point Patient Severity Assessment of Erythema (PSA)
Time frame: 12 weeks
Incidence of adverse events as a measure of safety and tolerability
Incidence of adverse events as a measure of safety and tolerability
Time frame: 12 weeks
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Omaha, Nebraska, United States
Dermata Investigational Site
High Point, North Carolina, United States
Dermata Investigational Site
Broomall, Pennsylvania, United States
Dermata Investigational Site
Nashville, Tennessee, United States
Dermata Investigational Site
Austin, Texas, United States
Dermata Investigational Site
Norfolk, Virginia, United States