Conditions: Plaque Psoriasis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 45
Healthy volunteers: no

Brief 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.

Detailed 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)

Arms:
arm 1: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.

Interventions: intervention 1: DFD-01 (betamethasone dipropionate) Spray, 0.05%
Intervention descriptions: intervention 1: DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.

Protocol document: