Efficacy of Crisaborole 2% Cream Versus Placebo in Mild to Moderate Atopic Eczema
Starting soon · Phase 4 · Has a placebo group
Conditions studied: Atopic Dermatitis (AD), Atopic Eczema
In brief
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.
Key facts
- Study ID
- NCT07438509
- Run by
- Jinnah Postgraduate Medical Centre
- People needed
- 270
- Starts
- 2026-03-01
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-03-06
Who can join
Age: 12 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Full record on ClinicalTrials.gov
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