Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital PsoriasisPhase 2NCT07543640
EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.
A Phase 2 study testing Methotrexate and Roflumilast 500 Mcg Oral Tablet in people with Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis, run by Eman Raafat Said.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis
- What is being tested?
- Methotrexate and Roflumilast 500 Mcg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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".
Who cannot join
- 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.
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- 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.
About this study
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.
- Conditions
- Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis
- Being tested
- Methotrexate, Roflumilast 500 Mcg Oral Tablet
- Keywords
- Roflumilast, Methotrexate, Genital Psoriasis, Flexural Psoriasis, Inverse Psoriasis, PDE-4 Inhibitor, Quality of Life, Pruritus
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called MTX
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 TabletDrug
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 group | Role | What they receive |
|---|---|---|
| Weekly Methotrexate (0.2-0.4 mg/kg) | Active comparator | 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 Receives: Drug: Methotrexate |
| Oral Roflumilast 500 mcg daily | Experimental | 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. Receives: Drug: Roflumilast 500 Mcg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success at flexural (I-IGA 0/1) and/or genital (sPGA-G 0/1) psoriasis
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.
Measured: week 16
Secondary outcomes (5)
Global Skin Clearance (PASI Responses)
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)
Measured: Week 16
Quality of Life Improvement (DLQI 0/1)
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.
Measured: week 16
Itch Relief (Itch-NRS)
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)
Measured: week 16
Safety and Tolerability (Adverse Events)
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.
Measured: Throughout the 16-week treatment period and during the follow-up period (at least 3 months)
Body Surface Area (BSA) Reduction
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.
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eman Raafat Said
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eman Raafat Said, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543640
- Sponsor's protocol ID
- MS-506-2024
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.
- ClinicalTrials.gov ID
- NCT07543640
- Acronym / sponsor ID
- MS-506-2024
- Conditions
- Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis
- Keywords
- Roflumilast, Methotrexate, Genital Psoriasis, Flexural Psoriasis, Inverse Psoriasis, PDE-4 Inhibitor, Quality of Life, Pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Eman Raafat SaidUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly Methotrexate (0.2-0.4 mg/kg) | Active comparator | Drug: MethotrexateThis 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 |
| Oral Roflumilast 500 mcg daily | Experimental | Drug: Roflumilast 500 Mcg Oral TabletThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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".
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateAlso: MTXParticipants 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. | Drug | Weekly Methotrexate (0.2-0.4 mg/kg) |
| Roflumilast 500 Mcg Oral TabletParticipants 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 | Drug | Oral Roflumilast 500 mcg daily |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methotrexate and Roflumilast 500 Mcg Oral Tablet in people with Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis, run by Eman Raafat Said.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success at flexural (I-IGA 0/1) and/or genital (sPGA-G 0/1) psoriasis (time frame: week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.