Oral roflumilast for people 12 and older with moderate-to-severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mansoura University Hospital
  Al Mansurah, Dakahlia Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Nora Mohamed Abdelrazik, MD Dermatology
• Email: noraeldarawany@gmail.com
• Phone: +201060291029

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.