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

Overview

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.

Detailed 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.

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.

Primary outcome measures

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

Secondary outcome measures (1)

• Safety / Tolerability [Time frame: throughout 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Fauji Foundation Hospital, Rawalpindi — Rawalpindi

Publications

• Kulthanan K, Tuchinda P, Nitiyarom R, Chunharas A, Chantaphakul H, Aunhachoke K, Chularojanamontri L, Rajatanavin N, Jirapongsananuruk O, Vichyanond P, Chatchatee P, Sangsupawanich P, Wananukul S, Singalavanija S, Trakanwittayarak S, Rerkpattanapipat T, Thongngarm T, Wisuthsarewong W, Limpongsanurak W, Kamchaisatian W, Noppakun N. Clinical practice guidelines for the diagnosis and management of at PMID 34246205
• AAAAI/ACAAI JTF Atopic Dermatitis Guideline Panel; Chu DK, Schneider L, Asiniwasis RN, Boguniewicz M, De Benedetto A, Ellison K, Frazier WT, Greenhawt M, Huynh J, Kim E, LeBovidge J, Lind ML, Lio P, Martin SA, O'Brien M, Ong PY, Silverberg JI, Spergel JM, Wang J, Wheeler KE, Guyatt GH; Patient Groups: Global Parents for Eczema Research; Capozza K; National Eczema Association; Begolka WS; Evidence PMID 38108679
• Chu DK, Chu AWL, Rayner DG, Guyatt GH, Yepes-Nunez JJ, Gomez-Escobar L, Perez-Herrera LC, Diaz Martinez JP, Brignardello-Petersen R, Sadeghirad B, Wong MM, Ceccacci R, Zhao IX, Basmaji J, MacDonald M, Chu X, Islam N, Gao Y, Izcovich A, Asiniwasis RN, Boguniewicz M, De Benedetto A, Capozza K, Chen L, Ellison K, Frazier WT, Greenhawt M, Huynh J, LeBovidge J, Lio PA, Martin SA, O'Brien M, Ong PY, Sil PMID 37678572
• Butala S, Paller AS. Optimizing topical management of atopic dermatitis. Ann Allergy Asthma Immunol. 2022 May;128(5):488-504. doi: 10.1016/j.anai.2022.03.004. Epub 2022 Mar 12. PMID 35288275
• Lax SJ, Van Vogt E, Candy B, Steele L, Reynolds C, Stuart B, Parker R, Axon E, Roberts A, Doyle M, Chu DK, Futamura M, Santer M, Williams HC, Cro S, Drucker AM, Boyle RJ. Topical anti-inflammatory treatments for eczema: network meta-analysis. Cochrane Database Syst Rev. 2024 Aug 6;8(8):CD015064. doi: 10.1002/14651858.CD015064.pub2. PMID 39105474
• Kim M, Del Duca E, Cheng J, Carroll B, Facheris P, Estrada Y, Cha A, Werth J, Bissonnette R, Nocka K, Zang C, Pavel AB, Guttman-Yassky E. Crisaborole reverses dysregulation of the mild to moderate atopic dermatitis proteome toward nonlesional and normal skin. J Am Acad Dermatol. 2023 Aug;89(2):283-292. doi: 10.1016/j.jaad.2023.02.064. Epub 2023 Apr 11. PMID 37054814
• 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 Feb;64(2):402-404. doi: 10.1111/ijd.17572. Epub 2024 Nov 20. No abstract available. PMID 39564717

Identifiers

NCT: NCT07519174 · FUMCRCT6

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗