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This randomized, open-label, parallel-group study will compare the efficacy and safety of Crisaborole 2% ointment and Tacrolimus 0.1% ointment in children with mild to moderate atopic dermatitis. A total of 66 participants will be randomized (1:1) to receive either Crisaborole or Tacrolimus, applied twice daily to affected areas for 28 days. Primary endpoint is proportion of participants achieving Investigator's Static Global Assessment (ISGA) success (clear/almost clear with ≥2-point improvement from baseline) at Day 28. Safety assessments include adverse events and local application site reactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crisaborole 2% Ointment | Active Comparator | Twice daily application to affected areas for 28 days |
|
| Tacrolimus 0.1% Ointment | Active Comparator | Twice daily application to affected areas for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crisaborole 2% | Drug | Apply thin layer to affected skin daily for 28 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with ISGA sucess ( clear / almost clear from baseline) at day 28. | 28 days | |
| Change in ISGA from baseline to day 28. | ISGA uses a 5-point scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe); negative change indicates improvement. | Baseline, Day 14, Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
Active viral, bacterial, or fungal skin infection at the treatment site
Recent use of topical corticosteroids, calcineurin inhibitors, PDE4 inhibitors, or immunosuppressive medication within past 2 weeks
Known hypersensitivity to study medications or components
Chronic inflammatory conditions (e.g., psoriasis and seborrheic dermatitis) that may interfere with evaluation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kheziema Maryum | Contact | 0310-4999940 | doc.kheziemamaryum@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shalamar Hospital Lahore | Lahore | Punjab Province | 54000 | Pakistan |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Tacrolimus 0.1% |
| Drug |
Apply thin layer to affected skin daily for 28 days. |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |