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New pill showdown: can roflumilast beat methotrexate for psoriasis in private areas?

NCT ID NCT07543640

Disease control Sponsor: Eman Raafat Said Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two oral medications—roflumilast and methotrexate—for psoriasis in skin folds and genital areas, which are often hard to treat with creams alone. Fifty-six adults with topical-resistant psoriasis will take one of the two pills for 16 weeks. Researchers will measure how well each drug clears the rash and improves quality of life, aiming to find a more convenient treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Roflumilast (a daily pill) and methotrexate (a weekly pill)
What this could lead to
If roflumilast works well, it could offer a convenient oral treatment for hard-to-treat psoriasis in sensitive areas, with less need for frequent lab monitoring.
What could go wrong
This is a small, early-phase trial with only 56 people, so results may not apply to everyone. Roflumilast may not be more effective than methotrexate, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Pruritus psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Flexural psoriasis (also known as inverse or intertriginous psoriasis) and genital psoriasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.