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)

Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Atopic Dermatitis: a Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Oral roflumilast

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ahmed Ibrahim Ali, Master degree of Dermatology; Phone Number: +201011442104; Email: Ahmed.abdelhadi@med.suezuni.edu.eg
• Study Contact Backup: Name: Nora Mohamed Abdelrazik, MD Dermatology; Phone Number: +201060291029; Email: noraeldarawany@gmail.com

Study Locations

• Egypt
  • Dakahlia Governorate
    • Al Mansurah, Dakahlia Governorate, Egypt, 35511
      • Recruiting
      • Mansoura University Hospital
      • Contact: Sara Hamdy Fouad, MD Dermatology; Phone Number: +201003486001; Email: sara_hamdy@mans.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Evaluation of Oral Roflumilast in Moderate to Severe Atopic Dermatitis; 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.

Drug: Oral roflumilast; Participants will receive oral roflumilast. The initial dose is 250 mcg once daily for the first 10 days, followed by a dose escalation to 500 mcg once daily for the remainder of the 12-week treatment period. Route: Oral Schedule: Daily for 12 weeks Duration: 12 weeks; Other Names: Roflumilast (generic name); Daxas (brand name in some countries); Roflumilast 500 mcg tablet (formulation identifier)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome of the study is the change in the SCORAD Index from baseline to the end of treatment	SCORAD is a validated scoring system that provides a comprehensive assessment of atopic dermatitis by combining: Extent of eczema: The percentage of total body surface area affected (0-100%), assessed using standard dermatologic mapping. Intensity of clinical signs: Six features-erythema, swelling ,oozing/crusts, scratch marks, lichenification, and dryness-each graded from 0 (absent) to 3 (severe). Patient-reported symptoms: Daily pruritus (itch) and sleep disturbance, each rated on a 0-10 visual analogue scale. The total SCORAD score ranges from 0 to 103, with higher values indicating more severe disease. Changes in SCORAD are reported as: Absolute reduction, and Percentage improvement from baseline (e.g., SCORAD-50 or SCORAD-75). This outcome measure captures both objective clinical improvement and patient-experienced symptom relief, providing a holistic evaluation of treatment efficacy.	Baseline and Weeks 4, 8, and 12.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - incidence of treatment-emergent adverse events and laboratory abnormalities.	Incidence and severity of adverse events (including diarrhea, nausea, abdominal pain, weight loss, decreased appetite, insomnia, headache) and clinically significant changes in CBC, hepatic profile, and serum creatinine.	Throughout treatment; labs at baseline and monthly (Weeks 4, 8, 12).

Collaborators and Investigators

• Sponsor: Nora Mohamed Abdelrazik
• Collaborators: Mansoura University Hospital
• Investigators: Study Chair: Abeer Mohamed Elkholy, MD Dermatology, Faculty of Medicine, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): May 20, 2026

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Estimated): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 28, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Atopic dermatitis; Adolescents and Adults; Oral roflumilast; Moderate-to-severe AD
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Pharmaceutical Preparations; Dosage Forms; Tablets; Roflumilast
• Other Study ID Numbers: R.25.11.3442.R1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No