EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.

EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.

Psoriasis affecting sensitive anatomical regions, such as the skin folds (flexural or inverse psoriasis) and genitalia, presents unique therapeutic challenges. These manifestations often result in a disproportionately high burden of disease, causing significant physical discomfort and a profound negative impact on a patient's quality of life and sexual health. While topical creams are the standard first-line treatment, many patients have "topically resistant" disease that requires a systemic (oral) approach.

This 16-week randomized controlled trial is the first to directly compare two oral medications for these specific sites: roflumilast (a daily 500 mcg pill) and methotrexate (a standard weekly dose). The study's primary objective is to evaluate which treatment is more effective at clearing psoriatic lesions in the skin folds and genital area, and how each drug improves the patient's overall quality of life and symptoms like pruritus (itching).

Participants are randomly assigned to one of the two treatment groups and are monitored monthly to assess skin clearance, symptom relief, and safety/tolerability. The goal of this research is to provide patients and healthcare providers with evidence-based data on a convenient, oral treatment option that does not require intensive laboratory monitoring.

Inclusion Criteria:

• Patients ≥ 18 years old.
• Patients of both genders.
• Patients with flexural and/or genital psoriasis that has been resistant to topical treatment, "No clearance or near clearance of lesions despite being compliant to treatment for 4 to 6 weeks".

Exclusion Criteria:

• Major systemic illness (cardiac, respiratory, renal, hepatic and gastrointestinal system).
• Severe anemia, leucopenia or thrombocytopenia.
• Pregnant and breastfeeding females.
• Hypersensitivity /intolerance to Roflumilast or methotrexate.
• Intake of systemic therapy for psoriasis within the last 3 Months.
• Patients receiving any relevant topical treatment for at least 2 weeks before initiation of our study.
• Erythrodermic, pustular psoriasis or psoriatic arthritis.
• Patients with autoimmune diseases e.g., SLE.
• Patients with solid or hematological malignancies e.g., breast cancer, leukemia, etc.
• Patients on biological therapy within the last 6 months prior to recruitment.