This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
401
Applied topically twice daily for 12 weeks
Applied topically twice daily for 12 weeks
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Birmingham, Alabama, United States
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)
The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.
Time frame: At End of treatment (up to 12 weeks) (LOCF)
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
Time frame: Baseline and End of treatment (up to 12 weeks) (LOCF)
Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
Time frame: At End of treatment (up to 12 weeks) (LOCF)
Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)
The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Subjects achieving a clear, minimal, or mild IGA at the end of treatment were considered as 'responder'. Subjects with an IGA of moderate or severe at the end of treatment were considered as 'non-responder'. Subjects who prematurely withdraw from study treatment because of lack of efficacy were coded as 'non-responders'.
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Unnamed facility
Fremont, California, United States
Unnamed facility
Santa Monica, California, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Miramar, Florida, United States
Unnamed facility
Omaha, Nebraska, United States
Unnamed facility
Albuquerque, New Mexico, United States
Unnamed facility
High Point, North Carolina, United States
Unnamed facility
Wilmington, North Carolina, United States
...and 10 more locations
Time frame: At End of treatment (up to 12 weeks) (LOCF)