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

Conditions

• Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Methotrexate — DRUG
  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, and complete blood counts to manage potential toxicities. In this study, it is used to provide a benchmark for efficacy in clearing sensitive "special sites" like skin folds and genitalia.
• Roflumilast 500 Mcg Oral Tablet — DRUG
  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. Furthermore, as a systemic small molecule, it distinguishes itself from traditional therapies by its lack of requirement for intensive, ongoing laboratory blood monitoring

Study Details

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.

Key Dates

Start date

Apr 1, 2026

Status verified

Apr 2026

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

56 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Weekly Methotrexate (0.2-0.4 mg/kg)
  This arm receives methotrexate at a dose of 0.2-0.4 mg/kg once weekly for 16 weeks. As methotrexate is a well-established standard systemic therapy for psoriasis, it serves as the active control to which the experimental drug is being compared
• Experimental: Oral Roflumilast 500 mcg daily
  This arm receives oral roflumilast at a fixed dose of 500 mcg once per day for 16 weeks. Since systemic roflumilast is currently used off-label for psoriasis and is the novel intervention being investigated in this study, it is classified as the experimental arm.

Primary Outcome Measure

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