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 (ROFLU-AD12)

Nora Mohamed Abdelrazik

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Oral roflumilast

Study type: Interventional

Funder types: Other

Identifiers

NCT07297602

R.25.11.3442.R1

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Evaluation of Oral Roflumilast in Moderate to Severe Atopic Dermatitis

Experimental group

Description:

All participants, both male and female, will receive oral roflumilast. No placebo or comparator is included. Male and female participants will be analyzed as subgroups for exploratory safety and efficacy outcomes.

Treatment:

Drug: Oral roflumilast