Efficacy and Safety of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Psoriasis area and severity index
Study Overview
Brief Summary
Psoriasis is a long standing inflammatory, autoinflammatory disease linked with many comorbidities. Patients with moderate to severe plaque psoriasis can be managed with topical as well as systemic medications. FDA approved Apremilast as first drug to be taken orally in cases of psoriasis in mid 1990's. Currently, according to researchers best knowledge no study has been done on use of Apremilast in Pakistan. It has recently become available here. Keeping in view all the benefits of this drug, a study has been planned to check its effectiveness and safety 30mg twice a day, in patients with moderate to severe chronic plaque psoriasis based on Psoriasis area and severity index and Body surface area assessments in our population.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed patients of chronic plaque psoriasis
- •patients applicant for oral or parenteral treatments and for light therapy
- •patients not responding to topical treatments
Exclusion Criteria
- •Patients who show hypersensitive reactions to apremilast to any of its inactive component
- •Pregnancy
- •Lactating mothers
Arms & Interventions
Apremilast 30 mg twice daily
Intervention: Apremilast 30mg (Drug)
Outcomes
Primary Outcomes
Psoriasis area and severity index
Time Frame: 16 weeks
body surface area
Time Frame: 16 weeks
Secondary Outcomes
No secondary outcomes reported