A Multicenter Study of 074-6751 Lotion in Subjects With Moderate Plaque Psoriasis
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|ClinicalTrials.gov Identifier: NCT03167515|
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : April 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Device: 074-6751 Lotion||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Study of 074-6751 Lotion in Subjects With Moderate Plaque Psoriasis|
|Actual Study Start Date :||May 16, 2017|
|Actual Primary Completion Date :||November 28, 2017|
|Actual Study Completion Date :||February 13, 2018|
|Experimental: 074-6751 Lotion||
Device: 074-6751 Lotion
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.
- Change from Baseline in sum of clinical signs of psoriasis (scaling, erythema, and plaque elevation) scores. [ Time Frame: Day 29 ]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.
- The proportion of subjects with improvement versus Baseline in IGA score. [ Time Frame: Day 29 ]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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167515
|United States, Florida|
|Tampa, Florida, United States, 33618|
|United States, Indiana|
|Carmel, Indiana, United States, 46032|
|Plainfield, Indiana, United States, 46168|
|United States, New Mexico|
|Albuquerque, New Mexico, United States, 87106|
|United States, North Carolina|
|High Point, North Carolina, United States, 27262|