Adjunctive Oral Iron Supplementation in Atopic Dermatitis

Inclusion criteria

• Adolescents aged 12 to 16 years.
• Diagnosis of atopic dermatitis according to Hanifin and Rajka or UK Working Party criteria.
• Mild to moderate disease defined as EASI score 1.1-7.0 for mild and 7.1-21.0 for moderate disease, according to the severity classification of Leshem et al. (2015).
• Stable standard-of-care topical therapy for at least two weeks prior to enrolment.
• Willingness to maintain baseline topical therapy throughout the study period.
• Written informed consent from a parent or legal guardian and assent from the participant will be obtained prior to enrolment.

Exclusion criteria

• Iron-related exclusions

• Known iron overload disorders (e.g., hereditary hemochromatosis).
• Ferritin above age- and sex-specific upper reference limits for adolescents (based on local laboratory pediatric reference ranges) in the absence of elevated CRP.
• Use of oral or intravenous iron supplementation within the previous three months.

Hematologic exclusions

• Haemoglobin less than 8 g/dL. Participants excluded on this basis will be referred to the haematology clinic for evaluation and management of severe anaemia, in accordance with the Declaration of Helsinki (Article 37).
• Known hemoglobinopathies (e.g., thalassemia major, sickle cell disease).
• Active bleeding or known bleeding disorders. Dermatologic exclusions
• Presence of other chronic inflammatory skin diseases that may interfere with assessment (e.g., psoriasis, bullous disorders).
• Active skin infection requiring systemic antibiotic therapy.
• Use of systemic treatments for atopic dermatitis, including:

• Systemic corticosteroids
• Immunosuppressants
• Biologic therapies within the following washout periods: dupilumab ≥12-16 weeks; cyclosporine ≥4 weeks; methotrexate ≥4-6 weeks; systemic corticosteroids ≥2-4 weeks.

Systemic exclusions

• Severe chronic illnesses that may affect study participation or safety, including:

• Advanced kidney disease
• Chronic liver disease
• Any other medical condition that, in the investigator's judgment, may interfere with study participation or outcomes.