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 | Not Yet Recruiting

• 1 other identifier: FUMCRCT6
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Atopic Dermatitis

Keywords

Dermatitis; atopic; tacrolimus; Calcineurin inhibitors; crisaborole

Outcome Measures

Primary Outcomes (1)

• mean reduction In EASI score.

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

  baseline to 8 weeks

Secondary Outcomes (1)

• Safety / Tolerability

  throughout 8 weeks

Study Arms (2)

Tacrolimus 0.03% Ointment

EXPERIMENTAL

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.

Drug: Tacrolimus

Crisaborole 2% Ointment

ACTIVE COMPARATOR

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.

Drug: Crisaborole 2% Top Oint

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.

Also known as: calcineurin inhibitor

Tacrolimus 0.03% Ointment

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.

Also known as: phosphodiesterase 4 inibitor

Crisaborole 2% Ointment

Eligibility Criteria

• Age: 2 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 2-20 years Clinically diagnosed mild to moderate AD EASI score ≤21 Informed consent

You may not qualify if:

• Severe AD (EASI \>21) Use of topical/systemic corticosteroids within 2 weeks Secondary infection Known drug hypersensitivity Immunocompromised state

Sponsors & Collaborators

• Fauji Foundation Hospital: collaborator
• Foundation University Islamabad: lead

Study Sites (1)

Fauji Foundation Hospital, Rawalpindi

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Related Publications (7)

• Kulthanan K, Tuchinda P, et al. Clinical practice guidelines for the diagnosis and management of atopic dermatitis.Asian Pac J Allergy Immunol. 2021;39(3):145-155.

  BACKGROUND

• AAAAI/ACAAI JTF Atopic Dermatitis Guideline Panel; Chu DK, Schneider L, et al. Atopic dermatitis (eczema) guidelines: 2023 AAAAI/ACAAI Joint Task Force on Practice Parameters. Ann Allergy Asthma Immunol. 2024;132(3):274-312.

  BACKGROUND

• Chu DK, Chu AWL, Rayner DG, et al. Topical treatments for atopic dermatitis (eczema): Systematic review and network meta-analysis of randomized trials. J Allergy Clin Immunol. 2023;152(6):1493-1519.

  BACKGROUND

• Butala S, Paller AS. Optimizing topical management of atopic dermatitis. Ann Allergy Asthma Immunol. 2022;128(5):488-504.

  BACKGROUND

• Lax SJ, Van Vogt E, Candy B, Steele L, Reynolds C, et al. Topical anti-inflammatory treatments for eczema: network meta-analysis. Cochrane Database Syst Rev. 2024;8:CD015064.

  BACKGROUND

• Kim M, Del Duca E, Cheng J, Carroll B, Facheris P, Estrada Y, et al. Crisaborole reverses dysregulation of the mild to moderate atopic dermatitis proteome toward nonlesional and normal skin. J Am Acad Dermatol. 2023;89(2):283-292. doi:10.1016/j.jaad.2023.02.064.

  BACKGROUND

• Chakraborty D, De A, Khan A, Dhar S, Raychaudhuri SP. Comparative evaluation of the efficacy and safety of crisaborole ointment (2%) versus tacrolimus ointment (0.1%) for the topical treatment of atopic dermatitis: an open-labeled single-blinded randomized controlled trial. Int J Dermatol. 2025;64:402-404. https://doi.org/10.1111/ijd.17572

  BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis

Interventions

Tacrolimus; Calcineurin Inhibitors; crisaborole

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Dr. Arfan ul Bari, FCPS Derma

  Foundation University Islamabad

  STUDY DIRECTOR

Central Study Contacts

Sana Khan, FCPS, Fellowship in Derma

CONTACT

+923391123231; drsanaderm@gmail.com

Dr. Asma Javed, FCPS Derma

CONTACT

+923009719514; ajkiani@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study is assessor-blinded: participants and caregivers are aware of the assigned treatment (tacrolimus 0.03% or crisaborole 2%), but the investigator evaluating outcomes (EASI score, pruritus VAS, and adverse effects) will be blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a parallel-group randomized controlled trial. Participants with mild-to-moderate atopic dermatitis will be randomly assigned to either tacrolimus 0.03% ointment or crisaborole 2% ointment, applied twice daily for 8 weeks. Each participant will remain in their assigned group throughout the study, and outcomes-including EASI score, pruritus, and adverse effects-will be assessed at baseline, Week 4, and Week 8 to compare the effectiveness and safety of the two treatments.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)