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Completed

NCT Number: NCT07537751

Crisaborole vs Fluticasone Propionate in Mild to Moderate Atopic Dermatitis

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.

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Key information

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Kafr Elsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Marcrisa cream 2%, Topical crisaborole

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.

Other names: Cutivate cream 0.05%, Topical fluticasone propionate

Primary outcomes

  1. Percentage improvement in objective SCORAD from baseline to Week 6

    Time frame: 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 outcomes

  1. Change in Investigator's Static Global Assessment (ISGA)

    Time frame: 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.

  2. Change in peak pruritus numerical rating scale

    Time frame: 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.

  3. Disease-free survival (relapse-free rate)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Noura Abdelmoneim Mohammed Elseessy

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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