Adjunctive Oral Iron Supplementation in Atopic Dermatitis

NCT07613190 | Not Yet Recruiting

• 1 other identifier: CL4181
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; Iron deficiency; Iron supplementation; EASI; CDLQI; SCOٌِRAD; EQ-5D-Y; Adolescents; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• • 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

Secondary Outcomes (16)

• Change in SCORing Atopic Dermatitis (SCORAD) score from baseline to weeks 6 and 12.

  12 weeks

• Change in Children's Dermatology Life Quality Index (CDLQI) from baseline to weeks 6 and 12.

  12 weeks

• Change in Patient-Oriented Eczema Measure (POEM) from baselines to weeks 6 and 12.

  12 weeks

• Change in EuroQol Visual Analogue Scale (EQ-VAS) from baseline to weeks 6 and 12.

  12 weeks

• Change in Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline to weeks 6 and 12.

  12 weeks

Study Arms (2)

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.

Dietary Supplement: Oral iron

Interventions

Oral iron DIETARY_SUPPLEMENT

Ferrodunal capsules providing 100 mg elemental oral iron once daily

standard-of-care topical therapy (emollients and steroids)+ Oral Iron

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).
• 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.
• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dermatitis, Atopic; Iron Deficiencies

Interventions

Iron

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; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Eglal AM Bassiouny, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eglal AM Bassiouny, PhD

CONTACT

00201061500242; eglal.mostafa@pharma.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share