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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard-of-care topical therapy (emollients and steroids) | No Intervention | Participants will receive standard-of-care topical therapy (emollients and steroids). Standard topical therapies for atopic dermatitis will be continued and documented. | |
| standard-of-care topical therapy (emollients and steroids)+ Oral Iron | Experimental | Participants will receive (Ferrodunal capsules providing 100 mg elemental oral iron once daily) in addition to standard-of-care topical therapy (emollients and steroids). The 100 mg fixed dose falls within the recommended paediatric dosing range of 3-6 mg/kg/day for most adolescents weighing ≥20 kg. Iron supplementation will be discontinued if serum ferritin exceeds 300 ng/mL on two consecutive measurements. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral iron | Dietary Supplement | Ferrodunal capsules providing 100 mg elemental oral iron once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| • Change in Eczema Area and Severity Index (EASI) score from baseline to week 12. | Higher scores indicate more severe atopic dermatitis, Minimum score is 0 and maximum is 72. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SCORing Atopic Dermatitis (SCORAD) score from baseline to weeks 6 and 12. | Higher scores indicate more severe disease and symptoms. Maximum score is 103 and minimum is zero. | 12 weeks |
| Change in Children's Dermatology Life Quality Index (CDLQI) from baseline to weeks 6 and 12. |
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Inclusion Criteria:
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 exclusions
Severe chronic illnesses that may affect study participation or safety, including:
Any other medical condition that, in the investigator's judgment, may interfere with study participation or outcomes.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eglal AM Bassiouny, PhD | Contact | 00201061500242 | eglal.mostafa@pharma.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Eglal AM Bassiouny, PhD | Cairo University | Principal Investigator |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D007501 | Iron |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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Higher scores indicate greater impairment in quality of life. Score from 0 to 30. |
| 12 weeks |
| Change in Patient-Oriented Eczema Measure (POEM) from baselines to weeks 6 and 12. | Higher scores indicate worse eczema symptoms. Maximum score is 28 and minimum is 0. | 12 weeks |
| Change in EuroQol Visual Analogue Scale (EQ-VAS) from baseline to weeks 6 and 12. | Higher scores indicate better perceived overall health. Score is from 0 to 100. | 12 weeks |
| Change in Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline to weeks 6 and 12. | Higher scores indicate more severe itching. Score is from 0 to 10. | 12 weeks |
| 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. | Higher scores indicate better health-related quality of life. Usually ≤1 (can be negative in some tariffs). | 12 weeks |
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008670 |
| Metals |