NCT07543640Not yet recruitingPhase 2
EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 14 Apr 2026
- Start date
- 1 Apr 2026
- Primary completion date
- Aug 2026
- Lead sponsor
- Eman Raafat Said
- Diseases
- Psoriasis
- NCT number
- NCT07543640
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 56
- From 1 Apr 2026 to the primary completion date, Aug 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Patients on biological therapy within the last 6 months prior to recruitment.
Other illness
- Major systemic illness (cardiac, respiratory, renal, hepatic and gastrointestinal system).
- Hypersensitivity /intolerance to Roflumilast or methotrexate.
- Patients with autoimmune diseases e.g., SLE.
- Patients with solid or hematological malignancies e.g., breast cancer, leukemia, etc.
Other
- Severe anemia, leucopenia or thrombocytopenia.
- Pregnant and breastfeeding females.
- Erythrodermic, pustular psoriasis or psoriatic arthritis.
Who the study is looking for
- 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".
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.