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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-20
SponsorFoundation University Islamabad

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

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Tacrolimus
  • Crisaborole 2% Top Oint

Treatment groups

72 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Foundation University Islamabad

Lead sponsor

Fauji Foundation Hospital

Collaborator