MedTrace Logo

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

NCT07519174 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-04-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Tacrolimus

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.

DRUG

Crisaborole 2% Top Oint

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.

Sponsors & Collaborators

  • Fauji Foundation Hospital

    collaborator OTHER

  • Foundation University Islamabad

    lead OTHER

Principal Investigators

  • Dr. Arfan ul Bari, FCPS Derma · Foundation University Islamabad

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-11-01
Completion
2027-01-01

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07519174 on ClinicalTrials.gov