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 (eczema)

Foundation University Islamabad

Status: Not yet enrolling

Conditions: Atopic Dermatitis

Treatments: Drug: Tacrolimus; Drug: Crisaborole 2% Top Oint

Study type: Interventional

Funder types: Other

Identifiers

NCT07519174

FUMCRCT6

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 2 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

72 participants in 2 patient groups

Tacrolimus 0.03% Ointment

Experimental group

Description:

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.

Treatment:

Drug: Tacrolimus

Crisaborole 2% Ointment

Active Comparator group

Description:

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.

Treatment:

Drug: Crisaborole 2% Top Oint