Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Independent objective reviewer scoring of matched photographs |
Two independent investigators will score matched photographs of the baseline rosacea at time point 0 weeks using a scale from 0 to 6. 0 indicates no papules, pustules, residual erythema, or telangiectasia; 1 indicates rare papules and/or pustules, residual to mild erythema, and mild to moderate telangiectasia; 2 indicates few papules and/or pustules, mild erythema, and mild to moderate telangiectasia; 3 indicates a distinct number of papules and/or pustules, mild to moderate erythema, and mild to moderate telangiectasia; 4 indicates a pronounced number of papules and/or pustules, moderate erythema, and mild to moderate telangiectasia; 5 indicates many papules and/or pustules occasionally with large inflamed lesions, moderate erythema, and moderate telangiectasia; and 6 indicates numerous papules and/or pustules occasionally with confluent areas of inflamed lesions, moderate or severe erythema, and moderate or severe telangiectasia. |
Done at 0 weeks of study |
|
Primary |
Independent objective reviewer scoring of matched photographs |
Two independent investigators will score matched photographs of the baseline rosacea at time point 4 weeks using a scale from 0 to 6. 0 indicates no papules, pustules, residual erythema, or telangiectasia; 1 indicates rare papules and/or pustules, residual to mild erythema, and mild to moderate telangiectasia; 2 indicates few papules and/or pustules, mild erythema, and mild to moderate telangiectasia; 3 indicates a distinct number of papules and/or pustules, mild to moderate erythema, and mild to moderate telangiectasia; 4 indicates a pronounced number of papules and/or pustules, moderate erythema, and mild to moderate telangiectasia; 5 indicates many papules and/or pustules occasionally with large inflamed lesions, moderate erythema, and moderate telangiectasia; and 6 indicates numerous papules and/or pustules occasionally with confluent areas of inflamed lesions, moderate or severe erythema, and moderate or severe telangiectasia. |
Done at 4 weeks of study |
|
Primary |
Independent objective reviewer scoring of matched photographs |
Two independent investigators will score matched photographs of the baseline rosacea at time point 8 weeks using a scale from 0 to 6. 0 indicates no papules, pustules, residual erythema, or telangiectasia; 1 indicates rare papules and/or pustules, residual to mild erythema, and mild to moderate telangiectasia; 2 indicates few papules and/or pustules, mild erythema, and mild to moderate telangiectasia; 3 indicates a distinct number of papules and/or pustules, mild to moderate erythema, and mild to moderate telangiectasia; 4 indicates a pronounced number of papules and/or pustules, moderate erythema, and mild to moderate telangiectasia; 5 indicates many papules and/or pustules occasionally with large inflamed lesions, moderate erythema, and moderate telangiectasia; and 6 indicates numerous papules and/or pustules occasionally with confluent areas of inflamed lesions, moderate or severe erythema, and moderate or severe telangiectasia. |
Done at 8 weeks of study |
|
Primary |
Independent objective reviewer scoring of matched photographs |
Two independent investigators will score matched photographs of the baseline rosacea at time point 12 weeks using a scale from 0 to 6. 0 indicates no papules, pustules, residual erythema, or telangiectasia; 1 indicates rare papules and/or pustules, residual to mild erythema, and mild to moderate telangiectasia; 2 indicates few papules and/or pustules, mild erythema, and mild to moderate telangiectasia; 3 indicates a distinct number of papules and/or pustules, mild to moderate erythema, and mild to moderate telangiectasia; 4 indicates a pronounced number of papules and/or pustules, moderate erythema, and mild to moderate telangiectasia; 5 indicates many papules and/or pustules occasionally with large inflamed lesions, moderate erythema, and moderate telangiectasia; and 6 indicates numerous papules and/or pustules occasionally with confluent areas of inflamed lesions, moderate or severe erythema, and moderate or severe telangiectasia. |
Done at 12 weeks of study |
|
Secondary |
Total number of papular and pustular lesions |
The total number of papular and pustular lesions will be recorded by the researcher. |
Done at 0 weeks of study |
|
Secondary |
Total number of papular and pustular lesions |
The total number of papular and pustular lesions will be recorded by the researcher. |
Done at 4 weeks of study |
|
Secondary |
Total number of papular and pustular lesions |
The total number of papular and pustular lesions will be recorded by the researcher. |
Done at 8 weeks of study |
|
Secondary |
Total number of papular and pustular lesions |
The total number of papular and pustular lesions will be recorded by the researcher. |
Done at 12 weeks of study |
|
Secondary |
Rosacea Quality of Life (QOL) Survey Response |
Patients will be asked to complete a rosacea-specific quality of life survey before the initiation of treatment to measure thoughts about their baseline rosacea. Answers are based on a scale from 1-5 and are quantifiable. |
Completed by patient at 0 weeks of study |
|
Secondary |
Rosacea Quality of Life (QOL) Survey Response |
Patients will be asked to complete a rosacea-specific quality of life survey after completion of treatment to measure thoughts about their rosacea. Answers are based on a scale from 1-5 and are quantifiable. |
Completed by patient at 12 weeks of study |
|