A Randomized Controlled Trial Comparing the Effectiveness and Safety of Topical Tacrolimus 0.03% Versus Crisaborole 2% in Patients With Mild to Moderate Atopic Dermatitis Over 8 Weeks

A Randomized Controlled Trial Comparing the Effectiveness and Safety of Topical Tacrolimus 0.03% Versus Crisaborole 2% in Patients With Mild to Moderate Atopic Dermatitis Over 8 Weeks

This randomized controlled trial compares the effectiveness and safety of topical tacrolimus 0.03% and crisaborole 2% in patients with mild to moderate atopic dermatitis over 8 weeks. Atopic dermatitis is a chronic inflammatory skin condition affecting quality of life, and steroid-sparing treatments are increasingly preferred due to adverse effects of long-term corticosteroid use. Tacrolimus, a calcineurin inhibitor, and crisaborole, a PDE-4 inhibitor, are both effective alternatives, though tacrolimus may offer greater efficacy while crisaborole has better tolerability. The study will include 70 patients aged 2-20 years, randomized into two groups receiving either treatment. Outcomes will be assessed using EASI score reduction and adverse effects. Data will be analyzed statistically to determine significance. The study aims to generate local evidence to guide treatment decisions and improve management strategies for atopic dermatitis in the Pakistani population.

This randomised controlled trial is designed to evaluate and compare the effectiveness and safety of two commonly used steroid-sparing topical therapies-tacrolimus 0.03% and crisaborole 2%-in patients with mild to moderate atopic dermatitis over an 8-week period. Atopic dermatitis is a chronic inflammatory condition marked by itching, dryness, and recurrent eczematous lesions, often resulting from a combination of impaired skin barrier function and immune dysregulation. While topical corticosteroids are widely used, their long-term adverse effects have led clinicians to increasingly rely on alternative agents such as calcineurin inhibitors and PDE-4 inhibitors. In this study, patients aged 2 to 20 years meeting the inclusion criteria will be enrolled and allocated into two treatment groups through randomization. One group will receive tacrolimus 0.03% ointment, while the other will receive crisaborole 2%, both applied twice daily. Baseline data including demographic details, disease duration, EASI score, and pruritus severity will be recorded, followed by reassessment at weeks 4 and 8. The primary measure of effectiveness will be the reduction in EASI score, while safety will be evaluated based on the frequency and type of adverse effects such as burning or irritation. Statistical analysis will be conducted using appropriate tests to compare outcomes between groups. The study aims to generate locally relevant evidence to guide clinical decision-making, with the expectation that tacrolimus may demonstrate superior efficacy, while both treatments maintain acceptable tolerability profiles.

Inclusion Criteria:

Age 2-20 years Clinically diagnosed mild to moderate AD EASI score ≤21 Informed consent

Exclusion Criteria:

Severe AD (EASI >21) Use of topical/systemic corticosteroids within 2 weeks Secondary infection Known drug hypersensitivity Immunocompromised state