Clinical trial

Roflumilast Versus Methotrexate in the Treatment of Psoriasis

Name

Kapu27

Description

Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor, which is approved in its oral form for chronic obstructive pulmonary disease, and in its topical form in the treatment of plaque psoriasis. Methotrexate is one of the conventional systemic treatments of psoriasis, so the aim of this study is to compare the efficacy and safety of roflumilast and methotrexate in the treatment of psoriasis

Trial arms

Trial start

2023-01-09

Estimated PCD

2023-05-09

Trial end

2023-05-14

Status

Completed

Phase

Early phase I

Treatment

Roflumilast

The patients will receive oral roflumilast in a dose of 500 mcg per day for 12 weeks

Arms:

Roflumilast

Other names:

Roflumilast oral

Methotrexate

The patients will receive methotrexate in a dose of 0.2- 0.4 mg/kg/week for 12 weeks

Arms:

Methotrexate

Other names:

Methotrexate tablets

Size

Primary endpoint

Psoriasis Severity Index (PASI) before and after Roflumilast

12 weeks

Psoriasis Severity Index (PASI) change with Roflumilast Vs Methotrexate

12 weeks

Eligibility criteria

Inclusion Criteria: 1. Patients with psoriasis vulgaris 2. Psoriatic patients not receiving any relevant systemic treatment for at least 4 weeks before initiation of our study 3. Psoriatic patients not receiving any relevant topical treatment for at least 2 weeks before initiation of our study Exclusion Criteria: 1. Erythrodermic or pustular psoriasis 2. Pregnant and lactating females 3. Patients with autoimmune diseases e.g. systemic lupus erythematosus 4. Patients with solid or hematological malignancies e.g., breast cancer, leukemia, etc.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

Updated at

2023-05-16

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug