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

Sponsor
Foundation University Islamabad
Study ID
NCT07519174
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 20 Years
Healthy Volunteers
Not accepted

Interventions

  • Tacrolimus — DRUG
    Tacrolimus 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 — DRUG
    Crisaborole 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.

Study Details

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.

Key Dates

First listed
Apr 9, 2026
Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Nov 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tacrolimus 0.03% Ointment
    Participants will apply tacrolimus 0.03% ointment 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-including EASI score, pruritus VAS, and adverse effects-will be assessed at baseline, Week 4, and Week 8. Describe the intervention(s) to be administered. For drugs use generic name and include dosage form, dosage, frequency and duration.
  • Active Comparator: Crisaborole 2% Ointment
    Participants will apply crisaborole 2% ointment twice daily to affected areas for 8 weeks. Crisaborole is a topical phosphodiesterase-4 inhibitor that modulates inflammatory pathways and restores skin homeostasis. Outcomes-including EASI score, pruritus VAS, and adverse effects-will be assessed at baseline, Week 4, and Week 8.

Primary Outcome Measure

mean reduction In EASI score. [ Time Frame: baseline to 8 weeks ]

Central Contacts

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