NCT07537751

Crisaborole vs Fluticasone Propionate in Mild to Moderate Atopic Dermatitis

Comparative Study Between Topical Crisaborole 2% and Topical Fluticasone Propionate 0.05% in Treatment of Patients With Mild to Moderate Atopic Dermatitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Noura Abdelmoneim Mohammed Elseessy · Academic / Other
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis
• Eczema

Interventions

Type	Name	Description
DRUG	Crisaborole 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.
DRUG	Fluticasone 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.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Egypt