About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Tacrolimus
DrugTacrolimus 0.03% ointment applied twice daily to affected areas for 8 weeks. Tacrolimus is a topical calcineurin inhibitor that reduces T-cell activation and inflammatory cytokine release, improving eczema severity. Outcomes (EASI score, pruritus VAS, adverse effects) assessed at baseline, Week 4, and Week 8.
Crisaborole 2% Top Oint
DrugCrisaborole 2% ointment applied twice daily to affected areas for 8 weeks. Crisaborole is a topical phosphodiesterase-4 inhibitor that modulates inflammatory pathways and restores skin homeostasis. Outcomes (EASI score, pruritus VAS, adverse effects) assessed at baseline, Week 4, and Week 8.
Treatment groups
Trial outcomes
Primary outcomes
mean reduction In EASI score.
Change in EASI score from baseline to Week 8. Greater reduction indicates better disease control.
Secondary outcomes
Safety / Tolerability
Frequency of treatment-related adverse effects such as burning, stinging, erythema, or local irritation.
Sponsors and contacts
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Foundation University Islamabad
Lead sponsor
Fauji Foundation Hospital
Collaborator
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