Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis, Iron deficiency, Iron supplementation, EASI, CDLQI, SCOٌِRAD, EQ-5D-Y, Adolescents, Randomized controlled trial
Brief summary
The present randomized controlled trial aims to evaluate the effect of adjunctive oral iron supplementation on disease severity and quality of life in adolescents with mild to moderate atopic dermatitis. In addition, the study will explore whether baseline iron status modifies treatment response and whether changes in iron biomarkers correlate with improvements in clinical severity scores.
Interventions
DIETARY_SUPPLEMENTOral iron
Ferrodunal capsules providing 100 mg elemental oral iron once daily
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Adolescents aged 12 to 16 years. 2. Diagnosis of atopic dermatitis according to Hanifin and Rajka or UK Working Party criteria. 3. 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). 4. Stable standard-of-care topical therapy for at least two weeks prior to enrolment. 5. Willingness to maintain baseline topical therapy throughout the study period. 6. 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 1. Known iron overload disorders (e.g., hereditary hemochromatosis). 2. Ferritin above age- and sex-specific upper reference limits for adolescents (based on local laboratory pediatric reference ranges) in the absence of elevated CRP. 3. Use of oral or intravenous iron supplementation within the previous three months. Hematologic exclusions 4. 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). 5. Known hemoglobinopathies (e.g., thalassemia major, sickle cell disease). 6. Active bleeding or known bleeding disorders. Dermatologic exclusions 7. Presence of other chronic inflammatory skin diseases that may interfere with assessment (e.g., psoriasis, bullous disorders). 8. Active skin infection requiring systemic antibiotic therapy. 9. 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 10. Severe chronic illnesses that may affect study participation or safety, including: * Advanced kidney disease * Chronic liver disease 11. Any other medical condition that, in the investigator's judgment, may interfere with study participation or outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • Change in Eczema Area and Severity Index (EASI) score from baseline to week 12. | 12 weeks | Higher scores indicate more severe atopic dermatitis, Minimum score is 0 and maximum is 72. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SCORing Atopic Dermatitis (SCORAD) score from baseline to weeks 6 and 12. | 12 weeks | Higher scores indicate more severe disease and symptoms. Maximum score is 103 and minimum is zero. |
| Change in Children's Dermatology Life Quality Index (CDLQI) from baseline to weeks 6 and 12. | 12 weeks | Higher scores indicate greater impairment in quality of life. Score from 0 to 30. |
| Change in Patient-Oriented Eczema Measure (POEM) from baselines to weeks 6 and 12. | 12 weeks | Higher scores indicate worse eczema symptoms. Maximum score is 28 and minimum is 0. |
| Change in EuroQol Visual Analogue Scale (EQ-VAS) from baseline to weeks 6 and 12. | 12 weeks | Higher scores indicate better perceived overall health. Score is from 0 to 100. |
| Change in Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline to weeks 6 and 12. | 12 weeks | Higher scores indicate more severe itching. Score is from 0 to 10. |
| Change in serum ferritin from baseline to weeks 6 and 12. | 12 weeks | — |
| Proportion of participants achieving EASI-50, EASI-75, and EASI-90. | 12 weeks | — |
| Adverse events frequency | 12 weeks | — |
| Medication adherence will be assessed through capsule counts at each follow-up visit. | 12 weeks | — |
| Correlation between baseline iron status strata and EASI score. (exploratory outcome) | 12 weeks | — |
| Correlation between change in iron biomarkers and change in EASI score. (exploratory outcome) | 12 weeks | — |
| Change in EQ-5D-Y index score from baseline to weeks 6 and 12. | 12 weeks | Higher scores indicate better health-related quality of life. Usually ≤1 (can be negative in some tariffs). |
| Change in serum iron from baseline to weeks 6 and 12. | 12 weeks | — |
| Change in serum hemoglobin from baseline to weeks 6 and 12. | 12 weeks | — |
| Change in serum CRP from baseline to weeks 6 and 12. | 12 weeks | — |
| Medication adherence will be assessed through participant self-report at each follow-up visit. | 12 weeks | — |
Contacts
CONTACTEglal AM Bassiouny, PhD
PRINCIPAL_INVESTIGATOREglal AM Bassiouny, PhD
Cairo University
Outcome results
None listed