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

Обзор

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.

Вмешательства

• Препарат Methotrexate
  Participants in this arm receive methotrexate at a weight-based dosage of 0.2-0.4 mg/kg administered once weekly for 16 weeks. Distinguishing Details: Methotrexate serves as the established active comparator and is a cornerstone of traditional systemic psoriasis therapy. It distinguishes itself from the experimental arm through its mechanism as a non-biologic immunosuppressant, and its requirement for comprehensive baseline and periodic laboratory monitoring of liver function, kidney function,
• Препарат Roflumilast 500 Mcg Oral Tablet
  Participants in this arm receive oral roflumilast at a fixed dose of 500 mcg administered once daily for a total of 16 weeks. Distinguishing Details: While roflumilast is a selective and potent phosphodiesterase-4 (PDE-4) inhibitor, this study evaluates its off-label systemic use specifically for flexural and/or genital psoriasis that has proven resistant to topical therapy. Unlike its counterpart apremilast, the protocol for this study involves a fixed dose without an initial titration phase.

Первичные конечные точки

• Clinical Success at flexural (I-IGA 0/1) and/or genital (sPGA-G 0/1) psoriasis [Срок оценки: week 16]

Вторичные конечные точки (5)

• Global Skin Clearance (PASI Responses) [Срок оценки: Week 16]
• Quality of Life Improvement (DLQI 0/1) [Срок оценки: week 16]
• Itch Relief (Itch-NRS) [Срок оценки: week 16]
• Safety and Tolerability (Adverse Events) [Срок оценки: Throughout the 16-week treatment period and during the follow-up period (at least 3 months)]
• Body Surface Area (BSA) Reduction [Срок оценки: week 16]

Критерии участия

Критерии включения

• 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".

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07543640 · MS-506-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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