Atopic Dermatitis, Eczema
Conditions
Keywords
Atopic dermatitis, Eczema, Crisaborole, Fluticasone propionate, Topical corticosteroid, PDE4 inhibitor, Pediatric eczema
Brief summary
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.
Detailed description
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.
Interventions
DRUGCrisaborole 2% topical ointment
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.
DRUGFluticasone propionate 0.05% topical cream
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.
Sponsors
Noura Abdelmoneim Mohammed Elseessy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children of either sex aged 1 to 12 years. * Clinical diagnosis of atopic dermatitis based on Hanifin and Rajka criteria. * Mild to moderate disease with objective SCORAD up to 40. * Investigator's Static Global Assessment (ISGA) score of 2 (mild) or 3 (moderate) at baseline.
Exclusion criteria
* Use of systemic corticosteroids, nonsteroidal systemic immunosuppressants (e.g., cyclosporine, methotrexate), or phototherapy within 4 weeks before baseline. * Use of topical corticosteroids, transdermal corticosteroids, topical antibiotics, or any medicated topical agent within 1 week before baseline. * Severe atopic dermatitis (objective SCORAD \> 40). * Significant medical condition requiring systemic medication (e.g., cancer). * Current clinical diagnosis of bacterial skin infection (such as abscess or impetigo).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage improvement in objective SCORAD from baseline to Week 6 | Baseline to Week 6 of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Investigator's Static Global Assessment (ISGA) | Baseline to Week 6 | ISGA score (0-4) is assessed at baseline and Week 6 to evaluate global clinical severity and response to treatment in each arm. |
| Change in peak pruritus numerical rating scale | Baseline to Week 18 | 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. |
| Disease-free survival (relapse-free rate) | Week 6 to Week 18 | 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. |
Countries
Egypt
Outcome results
None listed