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

Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Psoriasis: a Pilot Study

This is a 12-week, single-arm, open-label pilot study to assess the safety and preliminary efficacy of oral roflumilast in adults with moderate-to-severe plaque psoriasis. All participants, both male and female, will receive oral roflumilast starting at 250 mcg once daily for 10 days, followed by 500 mcg once daily for the remainder of the study. The primary outcome is the mean change in Psoriasis Area and Severity Index (PASI) score from baseline to Week 12. Secondary outcomes include change in body mass index (BMI) and safety assessments, including treatment-emergent adverse events, serious adverse events, and laboratory abnormalities. Male and female participants will be analyzed as subgroups.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis (PsO)
• Intervention / Treatment: Drug: Oral roflumilast

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nora Mohamed Abdelrazik, MD dDermatology; Phone Number: +201060291029; Email: noraeldarawany@gmail.com
• Study Contact Backup: Name: Ahmed Ibrahim Ali, Master degree of Dermatology; Phone Number: +201011442104; Email: Ahmed.abdelhadi@med.suezuni.edu.eg

Study Locations

• Egypt
  • Dakahlia Governorate
    • Al Mansurah, Dakahlia Governorate, Egypt, 35511
      • Recruiting
      • Mansoura University Hospital
      • Contact: Nora Mohamed Abdelrazik, MD degree of Dermatology; Phone Number: +201060291029; Email: noraeldarawany@gmail.com
      • Contact: Abeer Mohamed Elkholy, MD degree of Dermatology; Phone Number: +201006210646; Email: abeerkholy@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Oral Roflumilast for Adults with Moderate-to-Severe Psoriasis; All participants, both male and female, will receive oral roflumilast. No placebo or comparator is included. Male and female participants will be analyzed as subgroups for exploratory safety and efficacy outcomes.

Drug: Oral roflumilast; 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; Other Names: Roflumilast (generic name); Daxas (brand name in some countries); Roflumilast 500 mcg tablet (formulation identifier)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in Psoriasis Area and Severity Index (PASI) score	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.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body mass index (BMI)	Mean change in BMI (kg/m²), calculated from measured weight and height.	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Ahmed Ibrahim
• Collaborators: Mansoura University Hospital
• Investigators: Study Chair: Abeer Mohamed Elkholy, MD Dermatology, Faculity of Medicine, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 29, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Psoriasis; Adults; Plaque Psoriasis; Roflumilast; Pilot Study; Moderate to severe Psoriasis; Oral Roflumilast; PDE4 Inhibitor
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; Pharmaceutical Preparations; Dosage Forms; Tablets; Roflumilast
• Other Study ID Numbers: R.25.06.3223.R1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No