Actively Recruiting
A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults
Led by Ahmed Ibrahim · Updated on 2025-12-02
36
Participants Needed
1
Research Sites
27 weeks
Total Duration
On this page
Sponsors
A
Ahmed Ibrahim
Lead Sponsor
M
Mansoura University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official 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 18 years or older who need systemic therapy
- Chronic stable plaque psoriasis
- No use of other systemic psoriasis treatments in the last 2 months or never used systemic therapy before
- Use of safe contraception during the study
You will not qualify if you...
- Pregnant or breastfeeding women, or women who can become pregnant but are not using effective contraception
- Under 18 years of age
- Using other systemic psoriasis treatments like Acitretin or biologics
- Used systemic psoriasis treatment in the last 2 months
- Taking medications that affect cytochromes CYP3A4 or CYP1A
- Having systemic diseases other than COPD, especially liver problems
- Allergic to roflumilast or its ingredients
- Using contraception containing gestodene and ethinylestradiol
- Unreliable patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
A
Ahmed Ibrahim Ali, Master degree of Dermatology
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here