Atopic DermatitisNCT07537751
Crisaborole vs Fluticasone Propionate in Mild to Moderate Atopic Dermatitis
A study testing Crisaborole 2% topical ointment and Fluticasone propionate 0.05% topical cream in people with Atopic Dermatitis and Eczema, run by Noura Abdelmoneim Mohammed Elseessy at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Atopic Dermatitis, Eczema
- What is being tested?
- Crisaborole 2% topical ointment and Fluticasone propionate 0.05% topical cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Kafr Elsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate
About this study
Official title: 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.
Read the 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
- Being tested
- Crisaborole 2% topical ointment, Fluticasone propionate 0.05% topical cream
- Keywords
- Atopic dermatitis, Eczema, Crisaborole, Fluticasone propionate, Topical corticosteroid, PDE4 inhibitor, Pediatric eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisaborole 2% topical ointmentDrug
Also called Marcrisa cream 2%, Topical crisaborole
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
Also called Cutivate cream 0.05%, Topical fluticasone propionate
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Fluticasone propionate 0.05% topical cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 6 of treatment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Week 6 to Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Feb 2024
- Primary completion1 Dec 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noura Abdelmoneim Mohammed Elseessy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noura Abdelmoneim Mohammed Elseessy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537751
- Sponsor's protocol ID
- KFSIRB200-115
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Topical Crisaborole 2% and Topical Fluticasone Propionate 0.05% in Treatment of Patients With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07537751
- Acronym / sponsor ID
- KFSIRB200-115
- Conditions
- Atopic Dermatitis, Eczema
- Keywords
- Atopic dermatitis, Eczema, Crisaborole, Fluticasone propionate, Topical corticosteroid, PDE4 inhibitor, Pediatric eczema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Noura Abdelmoneim Mohammed ElseessyUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crisaborole 2% twice daily | Active comparator | Drug: Crisaborole 2% topical ointmentChildren 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). |
| Fluticasone propionate 0.05% twice daily | Active comparator | Drug: Fluticasone propionate 0.05% topical creamChildren 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). |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crisaborole 2% topical ointmentAlso: Marcrisa cream 2%, Topical crisaboroleCrisaborole 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 | Crisaborole 2% twice daily |
| Fluticasone propionate 0.05% topical creamAlso: Cutivate cream 0.05%, Topical fluticasone propionateFluticasone 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. | Drug | Fluticasone propionate 0.05% twice daily |
Primary outcome
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.
3 secondary outcomes
Change in Investigator's Static Global Assessment (ISGA)
Time frame: Baseline to Week 6
Change in peak pruritus numerical rating scale
Time frame: Baseline to Week 18
Disease-free survival (relapse-free rate)
Time frame: Week 6 to Week 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crisaborole 2% topical ointment and Fluticasone propionate 0.05% topical cream in people with Atopic Dermatitis and Eczema, run by Noura Abdelmoneim Mohammed Elseessy at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage improvement in objective SCORAD from baseline to Week 6 (time frame: Baseline to Week 6 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.