Oral roflumilast for people 12 and older with moderate-to-severe atopic dermatitis
Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Atopic Dermatitis: a Pilot Study
This 12-week pilot will test whether taking oral roflumilast once daily helps people aged 12 and older with moderate-to-severe atopic dermatitis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Mansoura University Hospital Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Trial ID | NCT07297602 on ClinicalTrials.gov |
What this trial studies
This is a 12-week, single-arm, open-label pilot in which all participants will start roflumilast 250 mcg once daily for 10 days then increase to 500 mcg once daily for the remainder of the trial. The main outcome is the mean change in SCORAD score from baseline to Week 12, with secondary outcomes focused on safety including treatment-emergent adverse events, serious adverse events, and lab abnormalities. Both male and female participants will be analyzed as subgroups to explore possible differences in response or safety. The study enrolls patients aged 12 years and older who require systemic therapy and have not used other systemic AD treatments in the prior two months.
Who should consider this trial
Good fit: Ideal candidates are people aged 12 or older with moderate-to-severe atopic dermatitis who need systemic therapy and have not used other systemic AD treatments in the last two months.
Not a fit: Patients who are pregnant or breastfeeding, have significant hepatic impairment, are taking strong CYP3A4/CYP1A inducers or inhibitors, or recently used other systemic AD treatments are unlikely to benefit from or qualify for this trial.
Why it matters
Potential benefit: If successful, oral roflumilast could provide a once-daily systemic option to reduce disease severity and symptoms for patients with moderate-to-severe atopic dermatitis.
How similar studies have performed: While topical PDE4 inhibitors and roflumilast formulations have shown promise in skin disease, oral roflumilast for moderate-to-severe atopic dermatitis is relatively novel with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * AD patients ≥ 12 years in whom systemic therapy is indicated. * Patients who don't use other systemic therapy for AD 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 \<12 years. * Other concomitant AD systemic treatments such as cyclosporins and biologics. * Previous systemic treatment of AD 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.
Where this trial is running
Al Mansurah, Dakahlia Governorate
- Mansoura University Hospital — Al Mansurah, Dakahlia Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Nora Mohamed Abdelrazik, MD Dermatology
- Email: noraeldarawany@gmail.com
- Phone: +201060291029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.