Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis
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|ClinicalTrials.gov Identifier: NCT03837743|
Recruitment Status : Active, not recruiting
First Posted : February 12, 2019
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Drug: DUR-928 Topical Solution Drug: Vehicle Topical Solution||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Proof of Concept Comparison Study of the Safety and Efficacy of DUR-928 Topical Solution With Occlusion in Subjects With Mild to Moderate Plaque Psoriasis|
|Actual Study Start Date :||February 21, 2019|
|Actual Primary Completion Date :||November 11, 2019|
|Estimated Study Completion Date :||March 2020|
Experimental: DUR-928 Topical Solution
DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Drug: DUR-928 Topical Solution
Topical solution containing active drug
Placebo Comparator: Vehicle Topical Solution
Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Drug: Vehicle Topical Solution
Topical solution containing no active drug
- The change from Baseline as assessed on the Investigator's Global Assessment (IGA) Score. [ Time Frame: Up to Day 57 ]The IGA of the Target Plaques will be determined on a 5-point scale ranging from "Clear - 0" to "Severe - 4."
- The change from Baseline as assessed on the Clinical Signs of Psoriasis (plaque elevation, scaling, and erythema) [ Time Frame: Up to Day 57 ]Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale ranging from "Clear - 0" to "Severe - 4."
- The change from Baseline as assessed on the Local Psoriasis Severity Index (LPSI) [ Time Frame: Up to Day 57 ]The LPSI is a sum of all three parameters including plaque elevation, scaling, and erythema.
- The change from Baseline as assessed by the Target Plaque Area. [ Time Frame: Up to Day 57 ]The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured.
- The change from Baseline as assessed on the Numeric Rating Scale (NRS) for Pruritus. [ Time Frame: Up to Day 57 ]The NRS score is based on an 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable."
- The change from Baseline as assessed on the Target Plaque Comparison [ Time Frame: Up to Day 57 ]The Target Plaque Comparison is scored on a 3-point scale: 1A = Target Plaque A is better than Target Plaque B, 0 = Target Plaque A is the same as Target Plaque B, and 1B = Target Plaque A is worse than Target Plaque B.
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): NCT03837743
|United States, California|
|San Diego, California, United States, 92123|
|United States, Florida|
|Brandon, Florida, United States, 33511|
|Miami, Florida, United States, 33162|
|United States, Indiana|
|Plainfield, Indiana, United States, 46168|
|United States, Washington|
|Spokane, Washington, United States, 99202|
|Study Director:||Tony Andrasfay||Therapeutics, Inc.|