Conditions: Plaque Psoriasis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief summary:
Sixteen week open label study of apremilast in combination with topical steroids with a four week safety follow up visit.

Detailed description:
This is an open label, 16 week study of apremilast in combination with topical corticosteroids (TCS). Twenty qualified subjects will be enrolled. Visits will consist of Baseline, 8 week, 16 week and a 20 week safety follow up after 4 weeks off treatment. Subjects will dose with apremilast as per label. Topical corticosteroids (TCS) will be used for up to Week 4 as per label and then will be used on an as needed basis until Week 16. Assessments will include Static Physicians Global Assessment (sPGA), Psoriasis Area Severity Index (PASI), Psoriatic Body Surface Area (BSA), Dermatology Life Quality Index (DLQI),Assessment of Pruritus, Patient Satisfaction questionnaire. and Patient Global Assessment (PtGA)

Arms:
arm 1: Apremilast, 30 mg. tablets, two times a day for 16 weeks

Interventions: intervention 1: Apremilast
Intervention descriptions: intervention 1: None

Protocol document:
Prot_SAP_000.pdf: