Tapinarof Versus Crisaborole for Pediatric Atopic Dermatitis: A Systematic Review and Meta-Analysis

Tapinarof Versus Crisaborole for Pediatric Atopic Dermatitis: A Systematic Review and Meta-Analysis

Authors

  • Wejdan Alhusaini Pediatrics Infectious Diseases Consultant, Associate Professor at University of Jeddah, Jeddah, Saudi Arabia.
  • Sara Alghamdi Al-Baha University, Al-Baha, Saudi Arabia
  • Waad Almutairy College of Medicine, University of Jeddah, Jeddah, Saudi Arabia
  • Mohammed Alahmadi College of Medicine, Taibah University, Medina, Saudi Arabia
  • Samar Aljubayri College of Medicine, University of Jeddah, Jeddah, Saudi Arabia
  • Malak Alsabban College of Medicine, Umm Al-Qura University, Makkah, Saudi Arabia
  • Fatmah Rednah College of Medicine, Umm Al-Qura University, Makkah, Saudi Arabia
  • Ali Alobaidi College of Medicine, University of Jeddah, Jeddah, Saudi Arabia

Keywords:

Atopic Dermatitis, Tapinarof, Crisaborole, Pediatric Dermatology

Abstract

Background: A chronic inflammatory skin ailment marked by pruritus and eczematous lesions, atopic dermatitis (AD) greatly lowers patient quality of life. Alternatives to corticosteroids have surfaced in nonsteroidal topical medicines such crisaborole and tapinarof, which provide focused anti-inflammatory effects with fewer general adverse effects.

Objective: The aim of this systematic review and meta-analysis was to assess and contrast the safety and efficacy profiles of crisaborole and tapinarof in the management of mild to moderate AD.

Methodology: A search of several databases produced 510 studies, after removing duplicates and applying eligibility criteria, 24 studies including a pooled sample of 8,218 patients (average age 17.5 years) were included. Using the Investigator's Static Global Assessment (ISGA) and Eczema Area and Severity Index (EASI), efficacy outcomes were evaluated; safety was based on incidence of adverse events.

Results: Among 1,164 patients receiving crisaborole, 61% (95% CI: 44-76%) achieved ISGA 0-1; 49% (95% CI: 43-55%) in the tapinarof group having no statistically significant difference (Chi=1.70, P=0.192). Similarly, 60% (95% CI: 55-65%) of crisaborole patients and 66% (95% CI: 53-82%) of those on tapinarof showed EASI improvement with no significant variation (Chi=1.11, P=0.293). Overall, 45% reported side effects (95% CI: 31-60%); comparable between crisaborole (38%) and tapinarof (62%) (Chi=1.03, P=0.309). Rare severe events and therapy discontinuation occurred for both drugs.

Conclusion: Mild to moderate AD may be effectively and safely managed with either crisaborole or tapinarof. With no major efficacy or safety differences, treatment choice can be guided by patient preference, tolerability, and clinical context.

References

Lyons JJ, Milner JD, Stone KD. Atopic dermatitis in children. Immunol Allergy Clin North Am. 2014;35(1):161–183. DOI:10.1016/j.iac.2014.09.008. PMID: 25459583.

Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66(Suppl 1):8–16. DOI:10.1159/000370220. PMID: 25925336.

Artusa S, Mazzuca G, Piacentini G, et al. Paediatric atopic dermatitis: the unexpected impact on life with a specific look at the molecular level. Int J Mol Sci. 2024;25(9):4778. DOI:10.3390/ijms25094778. PMID: 38731996.

Neri I, Galli E, Baiardini I, et al. Implications of atopic dermatitis on the quality of life of 6–11 years old children and caregivers (PEDI-BURDEN). J Asthma Allergy. 2023;16:383–396. DOI:10.2147/JAA.S404350. PMID: 37077900.

Otsuka A, Nomura T, Rerknimitr P, et al. The interplay between genetic and environmental factors in the pathogenesis of atopic dermatitis. Immunol Rev. 2017;278(1):246–262. DOI:10.1111/imr.12545. PMID: 28658541.

Criado PR, Miot HA, Bueno-Filho R, et al. Update on the pathogenesis of atopic dermatitis. An Bras Dermatol. 2024;99(6):895–915. DOI:10.1016/j.abd.2024.06.001. PMID: 39138034.

Moss C, Sathishkumar D. Topical therapy in atopic dermatitis in children. Indian J Dermatol. 2016;61(6):656. DOI:10.4103/0019-5154.193677.

Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis. J Am Acad Dermatol. 2014;71(1):116–132. DOI:10.1016/j.jaad.2014.03.023. PMID: 24813302.

Davari DR, Nieman EL, McShane DB, Morrell DS. Current perspectives on the management of infantile atopic dermatitis. J Asthma Allergy. 2020;13:563–573. DOI:10.2147/JAA.S246175. PMID: 33177843.

Sideris N, Paschou E, Bakirtzi K, et al. New and upcoming topical treatments for atopic dermatitis: a review of the literature. J Clin Med. 2022;11(17):4974. DOI:10.3390/jcm11174974. PMID: 36078904.

Carmona-Rocha E, Rusiñol L, Puig L. New and emerging oral/topical small-molecule treatments for psoriasis. Pharmaceutics. 2024;16(2):239. DOI:10.3390/pharmaceutics16020239. PMID: 38399292.

Dawe HR, Di Meglio P. The aryl hydrocarbon receptor (AHR): peacekeeper of the skin. Int J Mol Sci. 2025;26(4):1618. DOI:10.3390/ijms26041618. PMID: 40004095.

Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024;91(3):457–465. DOI:10.1016/j.jaad.2024.05.023. PMID: 38777187.

Fan T, Wang W, Wang Y, et al. PDE4 inhibitors: potential protective effects in inflammation and vascular diseases. Front Pharmacol. 2024;15:1407871. DOI:10.3389/fphar.2024.1407871. PMID: 38915460.

De A, Chakraborty D, Grisilda BN, et al. Efficacy and safety of crisaborole ointment in pediatric atopic dermatitis: a 4-week open-label study. Indian J Skin Allergy. 2024;3:60–65. DOI:10.25259/IJSA_45_2023.

Ma L, Zhang L, Kobayashi M, et al. Efficacy and safety of crisaborole ointment in Chinese and Japanese patients aged ≥2 years with mild-to-moderate atopic dermatitis. J Dermatol. 2023;50(7):847–855. DOI:10.1111/1346-8138.16792. PMID: 37154471.

Yang H, Li P, Shu H, et al. Efficacy and safety of proactive therapy with 2% crisaborole ointment in children with mild-to-moderate atopic dermatitis: a randomized controlled study. Pediatr Drugs. 2025. DOI:10.1007/s40272-025-00682-w. PMID: 39873962.

Chakraborty D, De A, Khan A, et al. 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. 2024. DOI:10.1111/ijd.17572. PMID: 39564717.

Gold LS, Del Rosso J, Ehst BD, et al. Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials. J Dermatol Treat. 2025;36(1). DOI:10.1080/09546634.2024.2444489. PMID: 39799945.

Bissonnette R, Pavel AB, Diaz A, et al. Crisaborole and atopic dermatitis skin biomarkers: an intrapatient randomized trial. J Allergy Clin Immunol. 2019;144(5):1274–1289. DOI:10.1016/j.jaci.2019.06.047. PMID: 36461082.

Eichenfield LF, Call RS, Forsha DW, et al. Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis. J Am Acad Dermatol. 2017;77(4):641–649.e5. DOI:10.1016/j.jaad.2017.06.010. PMID: 28823881.

Paller AS, Gold LS, Soung J, et al. Efficacy and patient-reported outcomes from a phase 2b randomized clinical trial of tapinarof cream for the treatment of adolescents and adults with atopic dermatitis. J Am Acad Dermatol. 2020;84(3):632–638. DOI:10.1016/j.jaad.2020.05.135. PMID: 32502588.

Peppers J, Paller AS, Maeda-Chubachi T, et al. A phase 2 randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis. J Am Acad Dermatol. 2018;80(1):89–98.e3. DOI:10.1016/j.jaad.2018.06.047. PMID: 30554600.

Zane LT, Kircik L, Call R, et al. Crisaborole topical ointment, 2% in patients ages 2 to 17 years with atopic dermatitis: a phase 1b open-label maximal-use systemic exposure study. Pediatr Dermatol. 2016;33(4):380–387. DOI:10.1111/pde.12872. PMID: 27193740.

Igarashi A, Tsuji G, Murata R, et al. A phase 2 randomized double-blind vehicle-controlled trial of tapinarof cream in Japanese pediatric patients with atopic dermatitis. J Dermatol. 2024. DOI:10.1111/1346-8138.17587.

Fujita K, Yagi M, Moriwaki S, et al. A phase 2b randomized double-blind multicenter vehicle-controlled study to assess the efficacy and safety of two crisaborole regimens in Japanese patients aged 2 years and older with mild-to-moderate atopic dermatitis. J Dermatol. 2021;48(11):1640–1651. DOI:10.1111/1346-8138.16120. PMID: 34435694.

Bissonnette R, Vasist LS, Bullman JN, et al. Systemic pharmacokinetics, safety, and preliminary efficacy of topical AHR agonist tapinarof: results of a phase 1 study. Clin Pharmacol Drug Dev. 2018;7(5):524–531. DOI:10.1002/cpdd.439. PMID: 29389078.

Ono R, Yagi M, Shoji A, et al. Phase 1 study of crisaborole in Japanese healthy volunteers and patients with atopic dermatitis. J Dermatol. 2019;47(1):25–32. DOI:10.1111/1346-8138.15123. PMID: 35846836.

Tom WL, Van Syoc M, Chanda S, et al. Pharmacokinetic profile, safety, and tolerability of crisaborole topical ointment, 2% in adolescents with atopic dermatitis: an open-label phase 2a study. Pediatr Dermatol. 2016;33(2):150–159. DOI:10.1111/pde.12780. PMID: 26777394.

Wolf JR, Chen A, Wieser J, et al. Improved patient- and caregiver-reported outcomes distinguish tacrolimus 0.03% from crisaborole in children with atopic dermatitis. J Eur Acad Dermatol Venereol. 2024;38(7):1364–1372. DOI:10.1111/jdv.19807. PMID: 38357778.

Silverberg J, Tallman A, Ports W, et al. Evaluating the efficacy of crisaborole using the atopic dermatitis severity index and percentage of affected body surface area. Acta Derm Venereol. 2020;100(13):adv00170. DOI:10.2340/00015555-3489. PMID: 32318744.

Simpson EL, Hebert AA, Browning J, et al. Tapinarof improved outcomes and sleep for patients and families in two phase 3 atopic dermatitis trials in adults and children. Dermatol Ther. 2025. DOI:10.1007/s13555-024-01318-6.

Eichenfield LF, Gower RG, Xu J, et al. Once-daily crisaborole ointment, 2%, as a long-term maintenance treatment in patients aged ≥3 months with mild-to-moderate atopic dermatitis: a 52-week clinical study. Am J Clin Dermatol. 2023;24(4):623–635. DOI:10.1007/s40257-023-00780-w. PMID: 37184828.

Schlessinger J, Shepard JS, Gower R, et al. Safety, effectiveness, and pharmacokinetics of crisaborole in infants aged 3 to <24 months with mild-to-moderate atopic dermatitis: a phase IV open-label study (CrisADe CARE 1). Am J Clin Dermatol. 2020;21(2):275–284. DOI:10.1007/s40257-020-00510-6. PMID: 32212104.

Simpson EL, Paller AS, Boguniewicz M, et al. Crisaborole ointment improves quality of life of patients with mild to moderate atopic dermatitis and their families. Dermatol Ther. 2018;8(4):605–619. DOI:10.1007/s13555-018-0263-0. PMID: 30345457.

Geng B, Hebert AA, Takiya L, et al. Efficacy and safety trends with continuous long-term crisaborole use in patients aged ≥2 years with mild-to-moderate atopic dermatitis. Dermatol Ther. 2021;11(5):1667–1678. DOI:10.1007/s13555-021-00584-y. PMID: 34379285.

Eichenfield LF, Gold LFS, Lynde C, et al. Maintenance of investigator’s static global assessment response with once-daily crisaborole in participants with mild to moderate atopic dermatitis. Dermatol Ther. 2024;14(4):875–892. DOI:10.1007/s13555-024-01129-9. PMID: 38546803.

You J, Li H, Wang Z, Zhao Y. Evaluating efficacy and safety of crisaborole in managing childhood mild to moderate atopic dermatitis: a systematic review and meta-analysis. Br J Hosp Med. 2025;1:19. DOI:10.12968/hmed.2024.0575. PMID: 39862023.

Zane LT, Hughes MH, Shakib S. Tolerability of crisaborole ointment for application on sensitive skin areas: a randomized double-blind vehicle-controlled study in healthy volunteers. Am J Clin Dermatol. 2016;17(5):519–526. DOI:10.1007/s40257-016-0204-6. PMID: 27335049.

Cao XC, Lu JW, Feng YF, et al. Efficacy and safety of ruxolitinib, crisaborole, and tapinarof for mild-to-moderate atopic dermatitis: a Bayesian network analysis of randomized controlled trials. Naunyn Schmiedebergs Arch Pharmacol. 2024;397(7):4657–4662. DOI:10.1007/s00210-024-02971-6. PMID: 38358466.

McDowell L, Olin B. Crisaborole: a novel nonsteroidal topical treatment for atopic dermatitis. J Pharm Technol. 2019;35(4):172–178. DOI:10.1177/8755122519844507. PMID: 40827120.

Spergel JM, Blaiss MS, Lio P, et al. Efficacy and safety of crisaborole in patients with mild-to-moderate atopic dermatitis and other atopic comorbidities. Allergy Asthma Proc. 2021;42(5):425–431. DOI:10.2500/aap.2021.42.210064. PMID: 34474712.

De Farias Santos ACF, Zamora FV, Cavalcante DVS, et al. Tapinarof cream in the treatment of atopic dermatitis in children and adults: a systematic review and meta-analysis. Cureus. 2025;2(1). DOI:10.1007/s44337-025-00283-z.

Fardos M, Cheedalla N, Watson AR, et al. Tapinarof in atopic dermatitis: a comprehensive scoping review of clinical efficacy and safety. JAAD Rev. 2024. DOI:10.1016/j.jdrv.2024.12.001.

Farkouh C, Anthony M, Abdi P, et al. Novel vehicles for drug delivery in atopic dermatitis: a narrative review. Dermatol Pract Concept. 2023;13(4):e2023216. DOI:10.5826/dpc.1304a216. PMID: 37992345.

Downloads

Published

2026-01-30

How to Cite

1.
Alhusaini W, Alghamdi S, Almutairy W, et al. Tapinarof Versus Crisaborole for Pediatric Atopic Dermatitis: A Systematic Review and Meta-Analysis. Dermatol Pract Concept. 2026;16(1):6285. doi:10.5826/dpc.1601a6285

Share