Patient Satisfaction Following Twice Daily Dosing With DFD-01 in Subjects With Moderate Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title: An Open-Label, Multicenter Study of Patient-Reported Satisfaction Following Twice Daily Dosing With Betamethasone Dipropionate Spray, 0.05% in Subjects With Moderate Plaque Psoriasis

Status Completed

Clinical Trial Summary

The purpose of this study is to assess clinical response and patient satisfaction when DFD-01 is used topically twice a day for moderate plaque psoriasis.

Clinical Trial Description

This multicenter, multi-dose, open-label study was designed to assess clinical response and patient-reported satisfaction after dosing with DFD-01 twice daily for 28 days. The product was approved for the treatment of mild to moderate plaque psoriasis by the FDA on February 5, 2016 before the first patient was enrolled.

Forty five (45) adult males and females, 18 years of age and older with a clinical diagnosis of moderate plaque psoriasis who met inclusion/exclusion criteria were randomized at the Baseline Visit. Each site attempted to enroll 50% of the patients with 3% to 10% body surface area (BSA) involved and 50% of the patients with > 10% BSA involved.

The initial dose of study product was self-administered by the patient and supervised by clinic staff during the Baseline Visit. Patients continued to apply the study product to all affected areas (avoiding the face, scalp, groin, axillae or other intertriginous areas) twice daily (approximately 12 hours apart) for 28 days. Patients visited the clinic for a total of up to five scheduled visits:

• Screening (Day -60 to 1)*

• Baseline (Day 1)

• Interim Visit (Day 8 ± 2)

• Interim Visit (Day 14 ± 3)

• End of Study (Day 29 ± 3) ;

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

• NCT number: NCT02749799
• Study type: Interventional
• Source: Primus Pharmaceuticals
• Status: Completed
• Phase: Phase 4
• Start date: February 2016
• Completion date: August 2016