About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Placebo Cream
- Crisaborole 2% Cream