Crisaborole vs Fluticasone Propionate in Mild to Moderate Atopic Dermatitis (NCT07537751) | Clinical Trial Compass
CompletedNot Applicable
Crisaborole vs Fluticasone Propionate in Mild to Moderate Atopic Dermatitis
Egypt40 participantsStarted 2024-02-01
Plain-language 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.
Who can participate
Age range
1 Year – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage improvement in objective SCORAD from baseline to Week 6