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

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.

Timeline

Start

2026-06-01

Primary completion

2026-11-01

Completion

2027-01-01

Publications

• Background 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 atopic dermatitis. Asian Pac J Allergy Immunol. 2021 Sep;39(3):145-155. doi: 10.12932/AP-010221-1050.
• Background 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 in Allergy Group; Chu AWL, Zhao IX, Chen L, Oykhman P, Bakaa L; AAAAI/ACAAI Joint Task Force on Practice Parameters; Golden D, Shaker M, Bernstein JA, Greenhawt M, Horner CC, Lieberman J, Stukus D, Rank MA, Wang J, Ellis A, Abrams E, Ledford D, Chu DK. Atopic dermatitis (eczema) guidelines: 2023 American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters GRADE- and Institute of Medicine-based recommendations. Ann Allergy Asthma Immunol. 2024 Mar;132(3):274-312. doi: 10.1016/j.anai.2023.11.009. Epub 2023 Dec 18.
• Background 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, Silverberg JI, Spergel JM, Smith Begolka W, Wang J, Wheeler KE, Gardner DD, Schneider L. Topical treatments for atopic dermatitis (eczema): Systematic review and network meta-analysis of randomized trials. J Allergy Clin Immunol. 2023 Dec;152(6):1493-1519. doi: 10.1016/j.jaci.2023.08.030. Epub 2023 Sep 9.
• Background 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.
• Background 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.
• Background 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.
• 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 Feb;64(2):402-404. doi: 10.1111/ijd.17572. Epub 2024 Nov 20. No abstract available.

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