Efficacy of Crisaborole 2% Cream Versus Placebo in Mild to Moderate Atopic Eczema (NCT07438509) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Efficacy of Crisaborole 2% Cream Versus Placebo in Mild to Moderate Atopic Eczema
270 participantsStarted 2026-03-01
Plain-language summary
This randomized controlled trial (RCT) aims to evaluate the efficacy and safety of Crisaborole 2% cream compared with placebo in patients with mild to moderate atopic dermatitis (AD), also known as atopic eczema. AD is a chronic inflammatory skin condition characterized by itching, redness, and recurrent flares that can significantly impair quality of life.
Eligible participants aged 12 to 50 years with mild to moderate AD will be randomly assigned to receive either Crisaborole 2% cream or a placebo cream applied twice daily for four weeks. The primary outcome is treatment success at Day 28, defined using the Investigator's Static Global Assessment (ISGA) as a score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline.
Participants will be evaluated at baseline, Day 14, and Day 28. Safety, tolerability, and compliance will also be assessed. The results of this RCT may provide locally relevant evidence to guide the management of mild to moderate AD.
Who can participate
Age range
12 Years – 50 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:
* Age 12 to 50 years
* Clinically diagnosed mild to moderate atopic dermatitis (ISGA score 2 or 3)
* Willing and able to apply topical medication twice daily for four weeks
* Able to provide written informed consent (parental consent for participants under 18 years)
Exclusion Criteria:
* Severe atopic dermatitis (ISGA score 4)
* Use of systemic corticosteroids, immunosuppressants, or antibiotics within the past two weeks
* Known hypersensitivity to crisaborole or any component of the formulation
* Pregnant or lactating women
* Presence of other significant dermatological conditions that may interfere with evaluation (e.g., psoriasis, scabies)
* Immunocompromised status (e.g., HIV infection, organ transplant recipient)
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
Proportion of Participants Achieving Treatment Success Based on Investigator's Static Global Assessment (ISGA)