NCT07297602 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
| NCT ID | NCT07297602 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Nora Mohamed Abdelrazik |
| Condition | Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2026-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 36 participants in total. It began in 2025-11-20 with a primary completion date of 2026-05-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Abeer Mohamed Elkholy, MD Dermatology
STUDY CHAIR
Faculty of medicine, Mansoura University
Frequently Asked Questions
Who can join the NCT07297602 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07297602 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07297602 currently recruiting?
Yes, NCT07297602 is actively recruiting participants. Contact the research team at noraeldarawany@gmail.com for enrollment information.
Where is the NCT07297602 trial being conducted?
This trial is being conducted at Al Mansurah, Egypt.
Who is sponsoring the NCT07297602 clinical trial?
NCT07297602 is sponsored by Nora Mohamed Abdelrazik. The principal investigator is Abeer Mohamed Elkholy, MD Dermatology at Faculty of medicine, Mansoura University. The trial plans to enroll 36 participants.
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