To evaluate the safety, efficacy, and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with rosacea.
This is primarily a safety study to evaluate the safety of AIV001 when administered to subjects with rosacea. Exploratory efficacy measures will also be collected as well as pharmacokinetic profiles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Cosmetic Laser Dermatology
San Diego, California, United States
Rate of Adverse Events
The occurrence of adverse events will be collected and reported using MedDRA to code. Description, start and end dates, and severity will be recorded.
Time frame: Day 1 through Day 84
Efficacy evaluated by the Investigator using the Investigator Global Assessment Scale
Evaluation of rosacea within the treatment area. 0 = clear (No papules and/or pustules; no or residual erythema; no or mild to moderate telangiectasia), 1 = minimal (Rare papules and/or pustules; residual to mild erythema; mild to moderate telangiectasia), 2 = mild (Few papules and/or pustules; mild erythema; mild to moderate telangiectasia), 3 = mild to moderate (Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate telangiectasia), 4 = moderate (Pronounced number of papules and/or pustules; moderate erythema; mild to moderate telangiectasia), 5 = moderate to severe (Many papules and/or pustules; occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia), and 6 = severe (Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe telangiectasia). Scores of 0 or 1 are considered success.
Time frame: Day 1 through Day 84
Efficacy evaluated by the Investigator by performing Inflammatory Lesion Counts
The number of inflammatory lesions is a static measure of the number of papules or pustules present within the treatment area.
Time frame: Day 1 through 84
Evaluation of Erythema and Topography using Standardized Photography
Photographs using standardized equipment will be taken and uploaded onto the vendor's server. The vendor will then use proprietary software to measure the amount of redness and the topography of the lesions within the treatment area.
Time frame: Day 1 through 84
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