NCT03000309

Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Derm Research, PLLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Apremilast

Timeline

• Start date: 2016-12-29
• Primary completion: 2018-04-01
• Completion: 2018-04-25
• First posted: 2016-12-22
• Last updated: 2019-03-28
• Results posted: 2019-03-28

Locations

1 site across 1 country: United States