Crisaborole vs Fluticasone Propionate in Mild to Moderate Atopic Dermatitis

April 12, 2026 updated by: Noura Abdelmoneim Mohammed Elseessy

Comparative Study Between Topical Crisaborole 2% and Topical Fluticasone Propionate 0.05% in Treatment of Patients With 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Kafr el-Sheikh Governorate
      • Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt
        • Faculty of Medicine, Kafr Elsheikh University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Crisaborole 2% twice daily
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
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
Active Comparator: Fluticasone propionate 0.05% twice daily
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 6 of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 6
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.
Baseline to Week 18
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.
Week 6 to Week 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Noura Abdelmoneim Mohammed Elseessy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KFSIRB200-115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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