This Phase 2 study has been designed to determine and compare the safety, tolerability, and efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied once daily for approximately four weeks in subjects with plaque psoriasis. Subjects will be instructed (randomly assigned) to apply DUR-928 solution to a target lesion on one arm and vehicle solution to a target lesion on the opposite arm once daily for up to four weeks. Subjects will occlude the treated areas for approximately two hours after each application.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
Topical solution containing active drug
Topical solution containing no active drug
Site 01
San Diego, California, United States
Site 04
Miami, Florida, United States
Site 05
Tampa, Florida, United States
Site 02
Plainfield, Indiana, United States
Site 03
The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score.
The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe
Time frame: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)
Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale.0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe.
Time frame: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI)
The LPSI is a sum of all three parameters (sum range of 0-12, with 12 being a worse outcome). Three parameters are plaque elevation, scaling, and erythema, each rated 0-4, 0=clear to 4=severe.
Time frame: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
The Change From Baseline as Assessed by the Target Plaque Area.
The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured.
Time frame: Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)
The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus.
The I-NRS score is based on an 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable."
Time frame: Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)
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Spokane, Washington, United States