EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methotrexate, Roflumilast 500 Mcg Oral Tablet.
- Who it may be relevant to
- Registry conditions: Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug 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, - Drug 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.
Primary outcome measures
- Clinical Success at flexural (I-IGA 0/1) and/or genital (sPGA-G 0/1) psoriasis [Time frame: week 16]
Secondary outcome measures (5)
- Global Skin Clearance (PASI Responses) [Time frame: Week 16]
- Quality of Life Improvement (DLQI 0/1) [Time frame: week 16]
- Itch Relief (Itch-NRS) [Time frame: week 16]
- Safety and Tolerability (Adverse Events) [Time frame: Throughout the 16-week treatment period and during the follow-up period (at least 3 months)]
- Body Surface Area (BSA) Reduction [Time frame: week 16]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07543640 · MS-506-2024