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

NCT07297602 | Recruiting Phase 2

• 1 other identifier: R.25.11.3442.R1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; Oral roflumilast; Moderate-to-severe AD; Efficacy; Safety; Adolescents and Adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety - incidence of treatment-emergent adverse events and laboratory abnormalities.

  Throughout treatment; labs at baseline and monthly (Weeks 4, 8, 12).

Study Arms (1)

Evaluation of Oral Roflumilast in Moderate to Severe Atopic Dermatitis

EXPERIMENTAL

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

Interventions

Oral roflumilast DRUG

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

Also known as: Roflumilast (generic name), Daxas (brand name in some countries), Roflumilast 500 mcg tablet (formulation identifier)

Evaluation of Oral Roflumilast in Moderate to Severe Atopic Dermatitis

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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.
• Hypersensitivity to the active substance of roflumilast or to any of its excipients.
• The use of contraception with gestodene and ethinylestradiol.
• Unreliable patients.

Sponsors & Collaborators

• Nora Mohamed Abdelrazik: lead
• Mansoura University Hospital: collaborator

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35511, Egypt

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Roflumilast; Tablets

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Abeer Mohamed Elkholy, MD Dermatology

  Faculty of medicine, Mansoura University

  STUDY CHAIR

Central Study Contacts

Nora Mohamed Abdelrazik, MD Dermatology

CONTACT

+201060291029; noraeldarawany@gmail.com

Ahmed Ibrahim Ali, Master degree of Dermatology

CONTACT

+201011442104; Ahmed.abdelhadi@med.suezuni.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study: neither the participants nor the investigators are blinded. All participants receive oral roflumilast, and both participants and study staff are aware of the treatment assignment. No placebo or comparator is used.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Dermatology

Model Details: This is a single-arm, open-label pilot study in which all participants, both male and female, receive oral roflumilast. Participants will not be randomized to different treatments. Male and female participants will be analyzed as subgroups to explore potential sex-based differences in safety and efficacy. No placebo or comparator group is included.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): May 20, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

EG (1)