Actively Recruiting
Evaluation of Efficacy and Safety of Oral Roflumilast for Treatment of Moderate to Severe Atopic Dermatitis in Patients Aged 12 Years and Older: A Pilot Study
Led by Nora Mohamed Abdelrazik · Updated on 2025-12-30
36
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
N
Nora Mohamed Abdelrazik
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 patients aged 12 years and older with moderate-to-severe atopic dermatitis 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 SCORAD (Scoring Atopic Dermatitis) score from baseline to Week 12. Secondary outcome include safety assessments, including treatment-emergent adverse events, serious adverse events, and laboratory abnormalities. Male and female participants will be analyzed as subgroups to explore potential differences in response or safety.
CONDITIONS
Official Title
Evaluation of Efficacy and Safety of Oral Roflumilast for Treatment of Moderate to Severe Atopic Dermatitis in Patients Aged 12 Years and Older: A Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 years or older with atopic dermatitis requiring systemic therapy
- No use of systemic therapy for atopic dermatitis in the last 2 months or systemic therapy-nafve
- 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 12 years
- Use of other systemic treatments for atopic dermatitis such as cyclosporins or biologics
- Use of systemic treatment for atopic dermatitis within the last 2 months
- Use of medications that induce or inhibit cytochromes CYP3A4 or CYP1A
- Presence of systemic diseases other than COPD, especially liver impairment
- Known hypersensitivity to roflumilast or any of its ingredients
- Use of contraception containing gestodene and ethinylestradiol
- Patients considered unreliable
AI-Screening
AI-Powered Screening
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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 Dermatology
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
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