Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Comment
  • Published:

Oral medicine

How safe is off-label use of imiquimod in oral lesions?

Evidence-Based Dentistry volume 25, pages 176–177 (2024)Cite this article

Subjects

Abstract

Data sources

A comprehensive search was conducted on PubMed and Embase, adhering to the principles outlined in the PRISMA Extension for Scoping Reviews (PRISMA-ScR). The search strategy was subsequently registered on PROSPERO.

Study selection

Articles were chosen based on an analysis of titles and abstracts, with no restrictions on publication date, language, or participant age. In vitro studies, animal studies, and literature reviews were excluded from consideration.

Data extraction and synthesis

Clinical trials in humans, case reports, or case series that reported the use of imiquimod for treating conditions in the oral or labial mucosa were included in this study. Results from duplicate articles were excluded from the analysis.

Results

Out of a total of 601 references initially identified, only 28 studies were included in the review. These studies were classified based on the use of imiquimod into three groups: potentially malignant disorders and oral cancer, lesions related to HPV, and autoimmune conditions. In all cases presented in the article, there is an occurrence of both local and systemic side effects.

Conclusions

The study elucidated the off-label use of imiquimod in oral pathologies, whether potentially malignant, cancerous, autoimmune, or associated with HPV infection. However, it was observed that further research is warranted for the development of a specific formulation for the oral mucosa, ensuring the drug’s sustained presence at its active site of action without interference from saliva and minimizing potential side effects.

Access through your institution
Buy or subscribe

This is a preview of subscription content, access via your institution

Access options

Access through your institution

Buy this article

  • Purchase on SpringerLink
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

References

  1. Hanna E, Abadi R, Abbas O. Imiquimod in dermatology: an overview. Int J Dermatol. 2016;55:831–44.

    Article  PubMed  CAS  Google Scholar 

  2. Gerster JF. 1H-Imidazo[4,5-c]quinolin-4-amines and antiviral use. 1987. U.S. patent no. 4,689,338.

  3. Özbağçıvan Ö, Ilknur T, Akarsu S, Lebe B, Fetil E. Oral leukoplakia: failure of topical imiquimod 5%. Turkderm Turkish Arch Dermatol Venereol. 2020;54:32–33.

    Google Scholar 

  4. Ramineni SK, Cunningham LL, Dziubla TD, Puleo DA. Development of imiquimod-loaded mucoadhesive films for oral dysplasia. J Pharm Sci. 2013;102:593–603.

    Article  PubMed  CAS  Google Scholar 

  5. de Mello Palma V, Frank LA, Balinha DM, Rados PV, Pohlmann AR, Guterres SS, et al. Is imiquimod a promising drug to treat oral mucosa diseases? A scoping review and new perspectives. Br J Clin Pharmacol. 2024;90:427–39.

    Article  PubMed  Google Scholar 

  6. Mane S, Patilsoman B, Bhate P, Das D, Malusare P, Tomar N. To evaluate the efficacy and tolerability of topical 5% imiquimod in cases of oral leukoplakia: a pilot study. J Indian Acad Oral Med Radiol. 2021;33:27–31.

    Article  Google Scholar 

  7. Wenzel K, Saka B, Zimmermann R, Gundlach KKH, Barten M, Gross G. Malignant conversion of florid oral and labial papillomatosis during topical immunotherapy with imiquimod. Med Microbiol Immunol. 2003;192:161–4.

    Article  PubMed  CAS  Google Scholar 

  8. Esquivel-Pedraza L, Fernández-Cuevas L, Saeb-Lima M, Guerrero-Ramos BA, Hernández-Salazar A, Méndez-Flores S. Recalcitrant oral squamous cell papilloma lesions in two HIV-infected patients successfully treated with topical imiquimod. J Dermatol Case Rep. 2015;9:19–22.

    Article  PubMed  PubMed Central  Google Scholar 

  9. Ruiz-Huertas P, Borrego-Luque A, Toledano-Valero P, Manzotti C, Rollón-Mayordomo Á. Oral florid papillomatosis: topical treatment with 5% imiquimod in orabase. Clin Exp Dent Res. 2022;8:858–62.

    Article  PubMed  PubMed Central  Google Scholar 

  10. Schön MP, Schön M. Imiquimod: mode of action. Br J Dermatol. 2007;157:8–13.

    Article  PubMed  Google Scholar 

  11. Skerlev M, Košćak IČ, Hadžavdić SL, Sirotković-Skerlev M Imiquimod. In: European Handbook of Dermatological Treatments. Springer International Publishing: Cham, 2023, pp 1685–1691.

Download references

Author information

Authors and Affiliations

  1. Faculty of Dentistry, University of Itaúna (UIT), Itaúna, MG, Brazil

    Ana Luisa Amaral & Sérgio Araújo Andrade

  2. Research Center on Biological Chemistry (NQBio), Federal University of São João del-Rei (UFSJ), Divinópolis, MG, Brazil

    Ana Luisa Amaral & Sérgio Araújo Andrade

  3. School of Health Sciences, University of Southampton, Southampton, UK

    Bashir Abdulgader Lwaleed

  4. Dept. of Diagnostic & Biomedical Sciences, University of Texas School of Dentistry at Houston, Houston, TX, USA

    Jerry Elmer Bouquot

  5. Optics and Photonics Research Center (CEPOF), Physics Institute of São Carlos of the University of São Paulo (IFSC-USP), São Carlos, SP, Brazil

    Sérgio Araújo Andrade

Authors
  1. Ana Luisa Amaral
    View author publications

    Search author on:PubMed Google Scholar

  2. Bashir Abdulgader Lwaleed
    View author publications

    Search author on:PubMed Google Scholar

  3. Jerry Elmer Bouquot
    View author publications

    Search author on:PubMed Google Scholar

  4. Sérgio Araújo Andrade
    View author publications

    Search author on:PubMed Google Scholar

Corresponding author

Correspondence to Sérgio Araújo Andrade.

Ethics declarations

Competing interests

The authors declare no competing interests.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Amaral, A.L., Lwaleed, B.A., Bouquot, J.E. et al. How safe is off-label use of imiquimod in oral lesions?. Evid Based Dent 25, 176–177 (2024). https://doi.org/10.1038/s41432-024-01026-2

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue date:

  • DOI: https://doi.org/10.1038/s41432-024-01026-2

Search

Advanced search

Quick links