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Tests treatment safety and results for Atopic Dermatitis
Official title 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
ClinicalTrials.gov ID: NCT07297602
What this study is testing
What is Oral roflumilast?
Oral roflumilast is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for atopic dermatitis.
Also referred to as Roflumilast (generic name), Daxas (brand name in some countries).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Al Mansurah, Dakahlia Governorate, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Al Mansurah, Dakahlia Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.