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Clinical Trial Summary

This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.


Clinical Trial Description

This study will be a multicenter (approximately 30 sites), randomized, vehicle-controlled, double-blind, and parallel group design. Approximately 264 subjects with moderate to severe plaque psoriasis will be randomized to treatment with DFD-06 Cream or Vehicle Cream. Subjects will use study product twice daily for 14 days. Subject visits are scheduled at Screening, Baseline (Day 1) and Days 4, 8, and 15. Clinical determinations of disease severity will be performed using the total sign score (TSS) for the target lesion and Investigator Global Assessment (IGA) for overall severity. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02445807
Study type Interventional
Source Promius Pharma, LLC
Contact
Status Completed
Phase Phase 3
Start date December 2015
Completion date July 2016

See also
  Status Clinical Trial Phase
Completed NCT02949388 - Efficacy and Safety of Prurisol Administered Orally for Active Moderate to Severe Chronic Plaque Psoriasis Phase 2
Completed NCT01891864 - Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel Phase 3
Completed NCT01012713 - Safety and Efficacy Study of Combination Treatment With Excimer Laser, Clobex Spray, and Vectical Ointment in the Treatment of Psoriasis Phase 4