NCT07297602RecruitingPhase 2
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
Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Atopic Dermatitis: a Pilot Study
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 9 Dec 2025
- Start date
- Nov 2025
- Primary completion date
- May 2026
- Lead sponsor
- Nora Mohamed Abdelrazik
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07297602
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 36
- From Nov 2025 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- Other systemic diseases other than COPD, especially hepatic impairment.
- Hypersensitivity to the active substance of roflumilast or to any of its excipients.
Age
- Age \<12 years.
Other
- Pregnant or lactating women, as well as women of childbearing potential not using an effective method of contraception.
- The use of contraception with gestodene and ethinylestradiol.
- Unreliable patients.
Who the study is looking for
- 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mansoura university Hospital Coordinator of this site? Confirm its status | Al Mansurah | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.