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NCT Number: NCT07543640

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.

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Key information

Conditions

Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: MTX

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

Primary outcomes

  1. Clinical Success at flexural (I-IGA 0/1) and/or genital (sPGA-G 0/1) psoriasis

    Time frame: week 16

    The proportion of patients achieving a score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline at the specific sensitive sites. This is assessed using the Investigator's Global Assessment for Flexural Psoriasis (I-IGA) for skin folds and the static Physician's Global Assessment of Genitalia (sPGA-G) for genital involvement.

Secondary outcomes

  1. Global Skin Clearance (PASI Responses)

    Time frame: Week 16

    The proportion of patients achieving clinically significant reductions in disease severity as measured by the Psoriasis Area and Severity Index (PASI), specifically the PASI 75, PASI 90, and PASI 100 benchmarks (representing ≥75%, ≥90%, and 100% improvement from baseline, respectively)

  2. Quality of Life Improvement (DLQI 0/1)

    Time frame: week 16

    The proportion of patients achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1, signifying that the skin condition has no impact at all on the patient's overall quality of life.

  3. Itch Relief (Itch-NRS)

    Time frame: week 16

    The proportion of patients achieving a clinically meaningful ≥4-point reduction from baseline in the Itch Numeric Rating Scale (Itch-NRS) or reaching an absolute score of 0 or 1 (no itch or minimal itch)

  4. Safety and Tolerability (Adverse Events)

    Time frame: Throughout the 16-week treatment period and during the follow-up period (at least 3 months)

    The incidence, nature, and severity of treatment-related adverse events (AEs) and serious adverse events (SAEs) documented in both treatment arms. This includes monitoring for dropouts specifically due to drug-related side effects.

  5. Body Surface Area (BSA) Reduction

    Time frame: week 16

    The proportion of patients achieving an absolute Body Surface Area (BSA) involvement of ≤1% or the mean percentage change in BSA from baseline to the end of the study.

Sponsors and collaborators

Lead sponsor

Eman Raafat Said

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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