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This randomized, double-blind trial compared topical crisaborole 2% with topical fluticasone propionate 0.05% in children aged 1-12 years with mild to moderate atopic dermatitis. Forty patients were assigned to receive either crisaborole or fluticasone twice daily on affected areas for 6 weeks, with responders (>75% improvement in SCORAD) continuing the same treatment twice weekly for 12 weeks as maintenance. The study evaluated improvement in disease severity using SCORAD and ISGA, pruritus scores, disease-free survival, and local tolerability. Both treatments were effective and well tolerated; fluticasone produced faster short-term improvement, while crisaborole showed a trend toward fewer relapses and similar overall safety in this pediatric population.
This single-center, randomized, double-blind, controlled study enrolled 40 children with mild to moderate atopic dermatitis, defined by Hanifin and Rajka criteria, ISGA 2-3, and objective SCORAD up to 40. Participants were randomized to topical crisaborole 2% or fluticasone propionate 0.05%, applied twice daily for 6 weeks, with eligible responders continuing twice-weekly maintenance for 12 weeks. Outcomes included percentage improvement in SCORAD at Week 6, changes in ISGA and pruritus, disease-free survival, and local adverse events such as burning or redness. Both regimens improved disease severity with acceptable safety; fluticasone had greater early SCORAD improvement, while crisaborole showed numerically higher disease-free survival and lower relapse rates during follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crisaborole 2% twice daily | Active Comparator | Children with mild to moderate atopic dermatitis receive topical crisaborole 2% ointment applied in a thin layer to all affected areas twice daily for 6 weeks, then twice weekly for 12 weeks as maintenance in responders (>75% SCORAD improvement). |
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| Fluticasone propionate 0.05% twice daily | Active Comparator | Children with mild to moderate atopic dermatitis receive topical fluticasone propionate 0.05% cream applied in a thin layer to all affected areas twice daily for 6 weeks, then twice weekly for 12 weeks as maintenance in responders (>75% SCORAD improvement). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crisaborole 2% topical ointment | Drug | Crisaborole 2% topical ointment applied in a thin layer to all affected atopic dermatitis lesions twice daily for 6 weeks, followed by twice-weekly application for 12 weeks as maintenance in patients who achieve more than 75% improvement in SCORAD at Week 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage improvement in objective SCORAD from baseline to Week 6 | Objective SCORAD is assessed at baseline and Week 6, and the percentage improvement is calculated as the change from baseline divided by the baseline score, expressed as a percentage, to compare treatment response between the two groups. | Baseline to Week 6 of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Investigator's Static Global Assessment (ISGA) | ISGA score (0-4) is assessed at baseline and Week 6 to evaluate global clinical severity and response to treatment in each arm. | Baseline to Week 6 |
| Change in peak pruritus numerical rating scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Kafr Elsheikh University | Kafr ash Shaykh | Kafr el-Sheikh Governorate | Egypt |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| 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 |
|---|---|
| C543085 | crisaborole |
| D009824 | Ointments |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D000730 | Androstadienes |
| D000736 | Androstenes |
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| Fluticasone propionate 0.05% topical cream | Drug | Fluticasone propionate 0.05% topical cream applied in a thin layer to all affected atopic dermatitis lesions twice daily for 6 weeks, followed by twice-weekly application for 12 weeks as maintenance in patients who achieve more than 75% improvement in SCORAD at Week 6. |
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Peak pruritus is measured using an 11-point numerical rating scale (0 = no itch, 10 = worst imaginable itch) completed by patients or their parents at baseline, Week 6, and during follow-up. |
| Baseline to Week 18 |
| Disease-free survival (relapse-free rate) | Among patients achieving >75% improvement in SCORAD at Week 6, the proportion remaining free of relapse (no increase in SCORAD >50% over the Week 6 value) is assessed using survival analysis during the 12-week follow-up. | Week 6 to Week 18 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000731 |
| Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |