The primary objective of this study is to determine the efficacy and safety of 074-6751 Lotion applied twice daily for four weeks (28 days) in clinical subjects with moderate plaque psoriasis.
Skin diseases that cause swelling like psoriasis can be improved by using products applied to cover the skin, keeping the skin moist. Keeping the skin moist will ease the local signs and symptoms, such as skin redness, scaling, and itching in patients with plaque psoriasis. Researchers are testing 074-6751 Lotion in clinical subjects with moderate plaque psoriasis to see if it can act as a protective barrier for the skin so the skin remains moist and heals over time. 074-6751 Lotion is an investigational device. Eligible clinical subjects will be enrolled in the study and apply 074-6751 Lotion twice daily to all psoriasis plaques in the assigned Treatment Area for 28 days. Efficacy will be assessed in the Treatment Area by Investigator's Global Association (IGA) score, clinical signs of psoriasis, pruritus, and percent BSA affected. Safety will be assessed by adverse events (AEs).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
95
Apply lotion once in the morning and once in the evening daily at approximately the same time every day with 12 hours between doses. Apply the lotion only to the active psoriatic lesions, as instructed by your study doctor.
Site 03
Tampa, Florida, United States
Site 04
Carmel, Indiana, United States
Site 05
Plainfield, Indiana, United States
Site 02
Albuquerque, New Mexico, United States
Site 01
Change from Baseline in sum of clinical signs of psoriasis (scaling, erythema, and plaque elevation) scores.
Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee.
Time frame: Day 29
The proportion of subjects with improvement versus Baseline in IGA score.
The Investigator's Global Assessment (IGA) will be assessed on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Time frame: Day 29
The proportion of subjects with improvement versus Baseline for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation)
Time frame: Day 29
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High Point, North Carolina, United States