A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults
Recruiting
Phase 2
Interventional Study
Psoriasis (PsO)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 36 (estimated)
- Sponsor
- Ahmed Ibrahim · Other
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About This Trial
This is a 12-week, single-arm, open-label pilot study to assess the safety and preliminary efficacy of oral roflumilast in adults with moderate-to-severe plaque psoriasis. 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 Psoriasis…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Psoriatic patients ≥ 18 years in whom systemic therapy is indicated.
* Chronic stable plaque psoriasis.
* Patients who don't use other systemic therapy for psoriasis in the last 2 months (or naïve who didn't use any systemic therapy before).
* Safe contraception during the stu…
Contacts
Ahmed Ibrahim Ali, Master degree of Dermatology
+201011442104
Ahmed.abdelhadi@med.suezuni.edu.eg
CONTACT