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
Recruiting
Phase 2
Interventional Study
Atopic Dermatitis
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
- 12 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 36 (estimated)
- Sponsor
- Nora Mohamed Abdelrazik · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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 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 th…
Trial Locations
Loading…
Loading trial locations…
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…
Contacts
Ahmed Ibrahim Ali, Master degree of Dermatology
+201011442104
Ahmed.abdelhadi@med.suezuni.edu.eg
CONTACT