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

NCT07233291 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-12-02

No results posted yet for this study

Summary

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.

Conditions

  • Psoriasis (PsO)

Interventions

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

Sponsors & Collaborators

  • Mansoura University Hospital

    collaborator OTHER

  • Ahmed Ibrahim

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07233291 on ClinicalTrials.gov