Atopic DermatitisNCT07613190
Adjunctive Oral Iron Supplementation in Atopic Dermatitis
A study testing Oral iron in people with Atopic Dermatitis, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Oral iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Adjunctive Oral Iron Supplementation in Atopic Dermatitis: A Randomized Controlled Trial
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
- Being tested
- Oral iron
- Keywords
- Atopic dermatitis, Iron deficiency, Iron supplementation, EASI, CDLQI, SCOٌِRAD, EQ-5D-Y, Adolescents, Randomized controlled trial
- Medical subject headings
- Dermatitis, Atopic, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ironDietary supplement
Ferrodunal capsules providing 100 mg elemental oral iron once daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Oral iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: 12 weeks
Secondary outcomes (16)
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.
Measured: 12 weeks
Change in Children's Dermatology Life Quality Index (CDLQI) from baseline to weeks 6 and 12.
Higher scores indicate greater impairment in quality of life. Score from 0 to 30.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Change in serum ferritin from baseline to weeks 6 and 12.
Measured: 12 weeks
Proportion of participants achieving EASI-50, EASI-75, and EASI-90.
Measured: 12 weeks
Adverse events frequency
Measured: 12 weeks
Medication adherence will be assessed through capsule counts at each follow-up visit.
Measured: 12 weeks
Correlation between baseline iron status strata and EASI score. (exploratory outcome)
Measured: 12 weeks
Correlation between change in iron biomarkers and change in EASI score. (exploratory outcome)
Measured: 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).
Measured: 12 weeks
Change in serum iron from baseline to weeks 6 and 12.
Measured: 12 weeks
Change in serum hemoglobin from baseline to weeks 6 and 12.
Measured: 12 weeks
Change in serum CRP from baseline to weeks 6 and 12.
Measured: 12 weeks
Medication adherence will be assessed through participant self-report at each follow-up visit.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startMay 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eglal Adel Mostafa Bassiouny, Cairo University
- Investigators
- Eglal AM Bassiouny, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613190
- Sponsor's protocol ID
- CL4181
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Oral Iron Supplementation in Atopic Dermatitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07613190
- Acronym / sponsor ID
- CL4181
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Iron deficiency, Iron supplementation, EASI, CDLQI, SCOٌِRAD, EQ-5D-Y, Adolescents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Oral ironParticipants 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. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- Iron-related exclusions
- Hematologic exclusions
- Systemic exclusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral ironFerrodunal capsules providing 100 mg elemental oral iron once daily | Dietary supplement | standard-of-care topical therapy (emollients and steroids)+ Oral Iron |
Primary outcome
• Change in Eczema Area and Severity Index (EASI) score from baseline to week 12.
Time frame: 12 weeks
Higher scores indicate more severe atopic dermatitis, Minimum score is 0 and maximum is 72.
16 secondary outcomes
Change in SCORing Atopic Dermatitis (SCORAD) score from baseline to weeks 6 and 12.
Time frame: 12 weeks
Change in Children's Dermatology Life Quality Index (CDLQI) from baseline to weeks 6 and 12.
Time frame: 12 weeks
Change in Patient-Oriented Eczema Measure (POEM) from baselines to weeks 6 and 12.
Time frame: 12 weeks
Change in EuroQol Visual Analogue Scale (EQ-VAS) from baseline to weeks 6 and 12.
Time frame: 12 weeks
Change in Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline to weeks 6 and 12.
Time frame: 12 weeks
Change in serum ferritin from baseline to weeks 6 and 12.
Time frame: 12 weeks
Proportion of participants achieving EASI-50, EASI-75, and EASI-90.
Time frame: 12 weeks
Adverse events frequency
Time frame: 12 weeks
Medication adherence will be assessed through capsule counts at each follow-up visit.
Time frame: 12 weeks
Correlation between baseline iron status strata and EASI score. (exploratory outcome)
Time frame: 12 weeks
Correlation between change in iron biomarkers and change in EASI score. (exploratory outcome)
Time frame: 12 weeks
Change in EQ-5D-Y index score from baseline to weeks 6 and 12.
Time frame: 12 weeks
Change in serum iron from baseline to weeks 6 and 12.
Time frame: 12 weeks
Change in serum hemoglobin from baseline to weeks 6 and 12.
Time frame: 12 weeks
Change in serum CRP from baseline to weeks 6 and 12.
Time frame: 12 weeks
Medication adherence will be assessed through participant self-report at each follow-up visit.
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eglal AM Bassiouny, PhD principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Oral iron in people with Atopic Dermatitis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eglal AM Bassiouny, PhD (00201061500242, eglal.mostafa@pharma.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Change in Eczema Area and Severity Index (EASI) score from baseline to week 12. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.