Actively Recruiting
Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Psoriasis: a Pilot Study
Led by Ahmed Ibrahim · Updated on 2025-12-02
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Ahmed Ibrahim
Lead Sponsor
M
Mansoura University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and preliminary effectiveness of oral roflumilast in adults with moderate-to-severe plaque psoriasis in this 12-week pilot study. The study focuses on measuring changes in psoriasis severity using the Psoriasis Area and Severity Index (PASI) score and includes monitoring changes in body mass index (BMI). Both male and female participants will be included and analyzed as subgroups to better understand treatment effects. All participants will receive oral roflumilast starting at 250 mcg once daily for the first 10 days, followed by an increased dose of 500 mcg once daily for the remaining weeks, totaling 12 weeks of treatment. There is no placebo or comparison group. The study is open-label and single-arm, meaning all participants know they receive the active drug. Participants will undergo detailed medical history reviews and clinical exams before starting treatment. During the 12 weeks, they will attend scheduled visits for assessments of psoriasis severity, BMI, and safety monitoring including adverse events and laboratory tests. Data will be collected and analyzed overall and by sex-based subgroups to evaluate treatment effects and safety.
CONDITIONS
Brief Title
A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Psoriatic patients aged 18 years or older who need systemic therapy.
- Chronic stable plaque psoriasis diagnosis.
- No use of other systemic psoriasis treatments in the last 2 months or treatment-naive.
- Use of safe contraception during the study period.
You will not qualify if you...
- Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception.
- Age under 18 years.
- Use of other systemic psoriasis treatments such as Acitretin or biologics.
- Previous systemic psoriasis treatment within the last 2 months.
- Use of drugs affecting cytochromes CYP3A4 and CYP1A.
- Presence of systemic diseases other than COPD, especially liver impairment.
- Allergy to roflumilast or its ingredients.
- Use of contraception containing gestodene and ethinylestradiol.
- Unreliable patients.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive oral roflumilast daily for 12 weeks to treat moderate to severe psoriasis. The dose starts at 250 mcg once daily for 10 days, then increases to 500 mcg once daily for the remainder of the treatment period.
Scheduled visits throughout the 12-week treatment period
Trial Site Locations
Total: 1 location
1
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, Egypt, 35511
Actively Recruiting
Research Team
N
Nora Mohamed Abdelrazik, MD dDermatology
A
Ahmed Ibrahim Ali, Master degree of Dermatology
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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