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NCT Number: NCT07297602

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

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.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location status: Recruiting

Location contact

Sara Hamdy Fouad, MD Dermatology

CONTACT

[email protected]

+201003486001

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Roflumilast (generic name), Daxas (brand name in some countries), Roflumilast 500 mcg tablet (formulation identifier)

Primary outcomes

  1. The primary outcome of the study is the change in the SCORAD Index from baseline to the end of treatment

    Time frame: Baseline and Weeks 4, 8, and 12.

    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.

Secondary outcomes

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Ibrahim Ali, Master degree of Dermatology

CONTACT

[email protected]

+201011442104

Nora Mohamed Abdelrazik, MD Dermatology

CONTACT

[email protected]

+201060291029

Sponsors and collaborators

Lead sponsor

Nora Mohamed Abdelrazik

Other

Collaborators

  • Mansoura University Hospital

Registry information

Official study title

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

Acronym: ROFLU-AD12

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 22, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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