A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults

This pilot study is designed to evaluate the safety and preliminary efficacy of oral roflumilast in adults with moderate-to-severe plaque psoriasis. The study was approved by the Mansoura University Faculty of Medicine Institutional Review Board (IRB), Approval Code: R.25.06.3223.R1, and participants will be enrolled only after obtaining informed consent.

Each participant will undergo a detailed history and clinical examination, including:

Personal history: name, age, sex, occupation, residence, marital status, number of children, and special habits of medical importance.

History of present illness: onset, course, duration of psoriasis, and precipitating factors.

Medication history: nature, route, dose, compliance, duration, effect, and side effects.

Family history: psoriasis or other dermatoses.

Past medical history: associated systemic, other dermatological diseases, or major surgical operations.

Menstrual and obstetric history (for female participants).

A general clinical examination will be performed to assess overall health and exclude any systemic diseases.

The study will monitor clinical response using the Psoriasis Area and Severity Index (PASI) and record body mass index (BMI) changes. Safety will be assessed through monitoring of treatment-emergent adverse events, serious adverse events, and routine laboratory tests. Participants will attend scheduled visits throughout the 12-week treatment period, and data will be analyzed overall and by sex-based subgroups.

• Oral roflumilast (Drug), also known as Roflumilast (generic name), Daxas (brand name in some countries), Roflumilast 500 mcg tablet (formulation identifier): Dosage: Participants will receive oral roflumilast. The initial dose is 250 mcg once daily for the first 10 days, followed by a dose escalation to 500 mcg once daily for the remainder of the 12-week treatment period. Route: Oral Schedule: Daily for 12 weeks Duration: 12 weeks

Primary outcomes

• Mean change in Psoriasis Area and Severity Index (PASI) score [Baseline to Week 12]: The mean difference in PASI score from baseline to Week 12 among adults with moderate-to-severe plaque psoriasis receiving oral roflumilast. PASI is a validated composite measure of psoriasis severity assessing erythema, induration, desquamation, and affected body surface area.

Secondary outcomes

• Change in body mass index (BMI) [Baseline to Week 12]: Mean change in BMI (kg/m²), calculated from measured weight and height.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Psoriatic patients ≥ 18 years in whom systemic therapy is indicated.
* Chronic stable plaque psoriasis.
* Patients who don't use other systemic therapy for psoriasis in the last 2 months (or naïve who didn't use any systemic therapy before).
* Safe contraception during the study.

Exclusion Criteria:

* Pregnant or lactating women, as well as women of childbearing potential not using an effective method of contraception.
* Age <18 years.
* Other concomitant psoriasis systemic treatments such as Acitretin and biologics.
* Previous systemic treatment of psoriasis in the last 2 months.
* Patients receiving inducers or inhibitors of cytochromes CYP3A4 and CYP1A.
* Other systemic diseases other than COPD, especially hepatic impairment.
* Hypersensitivity to the active substance of roflumilast or to any of its excipients
* The use of contraception with gestodene and ethinylestradiol
* Unreliable patients.

• Abeer Mohamed Elkholy, MD Dermatology, Study chair, Faculity of Medicine, Mansoura University