Crisaborole vs Fluticasone Propionate in Mild to Moderate Atopic Dermatitis

Noura Abdelmoneim Mohammed Elseessy40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Interventions

Crisaborole 2% topical ointmentDRUG

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.

Fluticasone propionate 0.05% topical creamDRUG

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.

Eligibility

Sex: ALLMin age: 1 YearMax age: 12 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: Baseline to Week 6 of treatment

Secondary Outcomes

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.

Time frame: Baseline to Week 6

Change in peak pruritus numerical rating scale

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.

Time frame: 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.

Time frame: Week 6 to Week 18