Crisaborole vs Fluticasone Propionate in Mild to Moderate Atopic Dermatitis

NCT07537751 | Completed

• 1 other identifier: KFSIRB200-115
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Eczema

Keywords

Atopic dermatitis; Eczema; Crisaborole; Fluticasone propionate; Topical corticosteroid; PDE4 inhibitor; Pediatric eczema

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in Investigator's Static Global Assessment (ISGA)

  Baseline to Week 6

• Change in peak pruritus numerical rating scale

  Baseline to Week 18

• Disease-free survival (relapse-free rate)

  Week 6 to Week 18

Study Arms (2)

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).

Drug: Crisaborole 2% topical ointment

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).

Drug: Fluticasone propionate 0.05% topical cream

Interventions

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.

Also known as: Marcrisa cream 2%, Topical crisaborole

Crisaborole 2% twice daily

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.

Also known as: Cutivate cream 0.05%, Topical fluticasone propionate

Fluticasone propionate 0.05% twice daily

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Noura Abdelmoneim Mohammed Elseessy: lead

Study Sites (1)

Faculty of Medicine, Kafr Elsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

crisaborole; Ointments; Fluticasone

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Dermatology Department, Faculty of Medicine, Kafr Elsheikh University

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start: February 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

EG (1)