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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Tacrolimus 0.03% OintmentExperimental treatment 1 intervention
Group B: Crisaborole 2% OintmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

mean reduction In EASI score.

Change in EASI score from baseline to Week 8. Greater reduction indicates better disease control.

Time frame
baseline to 8 weeks

Secondary outcomes

1

Safety / Tolerability

Frequency of treatment-related adverse effects such as burning, stinging, erythema, or local irritation.

Time frame
throughout 8 weeks

Other outcomes

Sponsors and contacts

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Foundation University Islamabad

Lead sponsor

Fauji Foundation Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: