Ignite Creation Date:
2025-12-24 @ 7:22 AM
Ignite Modification Date:
2025-12-24 @ 7:22 AM
Study NCT ID:
NCT07297602
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Nora Mohamed Abdelrazik
Organization:
Study Overview
Official Title:
Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Atopic Dermatitis: a Pilot Study
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROFLU-AD12
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: