Skip to main content
Log in

Topical Minocycline Foam 4%: A Review in Acne Vulgaris

  • Adis Drug Evaluation
  • Published:
American Journal of Clinical Dermatology Aims and scope Submit manuscript

Abstract

Topical minocycline foam 4% (Amzeeq™) is approved in the USA for the treatment of inflammatory lesions of non-nodular, moderate to severe acne vulgaris (acne) in patients aged ≥ 9 years. It was developed to minimize systemic minocycline absorption and toxicity, and its high lipid content allows efficient drug movement through sebum and into affected sites. The favorable in vitro resistance profile of oral minocycline seen in Cutibacterium acnes (C. acnes) isolates was maintained with topical minocycline foam 4%. In 12-week, phase III clinical trials, once-daily topical minocycline foam 4% significantly improved both inflammatory and noninflammatory lesions relative to foam vehicle in patients aged ≥ 9 years with moderate to severe acne and was reported by most patients to be satisfactory or highly satisfactory to use. Extension trial data indicated that topical minocycline foam 4% continued to be effective for up to 52 weeks’ therapy. Topical minocycline foam 4% was generally well tolerated in these patients, with most adverse events (AEs) and all serious AEs considered to be unrelated to treatment. Cutaneous AEs were uncommon, and findings from a dermal safety study showed that topical minocycline foam 4% did not have any effects related to phototoxicity, photoallergy, skin sensitization and skin irritation. Topical minocycline foam 4% is thus a useful addition to available treatment options for the management of inflammatory lesions of non-nodular, moderate to severe acne in adult and pediatric patients aged ≥ 9 years.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945–73 e33.

  2. Williams HC, Dellavalle RP, Garner S. Acne vulgaris. Lancet. 2012;379(9813):361–72.

    Article  Google Scholar 

  3. Cengiz GF, Gurel G. Difficulties in emotion regulation and quality of life in patients with acne. Qual Life Res. 2020;29(2):431–8.

    Article  Google Scholar 

  4. Thiboutot D, Gollnick H, Bettoli V, et al. New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne group. J Am Acad Dermatol. 2009;60(Suppl 5):S1–50.

    Article  Google Scholar 

  5. Zouboulis CC, Jourdan E, Picardo M. Acne is an inflammatory disease and alterations of sebum composition initiate acne lesions. J Eur Acad Dermatol Venereol. 2014;28(5):527–32.

    Article  CAS  Google Scholar 

  6. Das S, Reynolds RV. Recent advances in acne pathogenesis: implications for therapy. Am J Clin Dermatol. 2014;15(6):479–88.

    Article  Google Scholar 

  7. Bienenfeld A, Nagler AR, Orlow SJ. Oral antibacterial therapy for acne vulgaris: an evidence-based review. Am J Clin Dermatol. 2017;18(4):469–90.

    Article  Google Scholar 

  8. Xu H, Li H. Acne, the skin microbiome, and antibiotic treatment. Am J Clin Dermatol. 2019;20(3):335–44.

    Article  Google Scholar 

  9. Biswal I, Gaind R, Kumar N, et al. In vitro antimicrobial susceptibility patterns of Propionibacterium acnes isolated from patients with acne vulgaris. J Infect Dev Ctries. 2016;10(10):1140–5.

    Article  CAS  Google Scholar 

  10. Foamix Pharmaceuticals Ltd. AMZEEQ™ (minocycline) topical foam: US prescribing information. 2019. https://www.fda.gov/. Accessed 16 Apr 2020.

  11. Kircik L, Del Rosso JQ, Weiss JS, et al. Formulation and profile of FMX101 4% minocycline topical foam for the treatment of acne vulgaris. J Clin Aesthet Dermatol. 2020;13(4):14–21.

    Google Scholar 

  12. Sutcliffe J, McLaughlin R, Webster G, et al. Susceptibility of Cutibacterium acnes to topical minocycline foam. Anaerobe. 2020;62:102169.

    Article  CAS  Google Scholar 

  13. Jones TM, Ellman H, deVries T. Pharmacokinetic comparison of once-daily topical minocycline foam 4% vs oral minocycline for moderate-to-severe acne. J Drugs Dermatol. 2017;16(10):1022–8.

    CAS  PubMed  Google Scholar 

  14. Eichenfield L, Stein Gold L, Silverberg N, et al. Clinical safety and pharmacokinetics of FMX101 4% topical minocycline foam in pediatric patients for the treatment of moderate-to-severe acne vulgaris [poster]. Pediatr Dermatol. 2019;36(5):767–95.

    Article  Google Scholar 

  15. Raoof TJ, Hooper D, Moore A, et al. Efficacy and safety of a novel topical minocycline foam for the treatment of moderate to severe acne vulgaris: a phase 3 study. J Am Acad Dermatol. 2020;82(4):832–7.

    Article  CAS  Google Scholar 

  16. Stein Gold L, Dhawan S, Weiss J, et al. A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: results of 2 randomized, double-blind, phase 3 studies. J Am Acad Dermatol. 2019;80(1):168–77.

    Article  Google Scholar 

  17. Shemer A, Shiri J, Mashiah J, et al. Topical minocycline foam for moderate to severe acne vulgaris: phase 2 randomized double-blind, vehicle-controlled study results. J Am Acad Dermatol. 2016;74(6):1251–2.

    Article  CAS  Google Scholar 

  18. Stein Gold L, Dhawan S, Weiss J, et al. Open-label extension study evaluating long-term safety and efficacy of FMX101 4% minocycline foam for moderate-to-severe acne vulgaris. J Clin Aesthet Dermatol. 2019;12(10):16–23.

    PubMed  PubMed Central  Google Scholar 

  19. Stein Gold L, Dhawan S, Weiss J, et al. An open-label extension of two phase 3 studies evaluating long-term efficacy of FMX101 4% minocycline foam for the treatment of acne vulgaris [poster]. In: 15th Annual Coastal Dermatology Symposium. 2019.

  20. Dosik J, Ellman H, Stuart I. Topical minocycline foam 4%: results of four phase 1 studies evaluating the potential for phototoxicity, photoallergy, sensitization, and cumulative irritation. J Immunotoxicol. 2019;16(1):133–9.

    Article  CAS  Google Scholar 

  21. Hauk L. Acne vulgaris: treatment guidelines from the AAD. Am Fam Physician. 2017;95(11):740–1.

    PubMed  Google Scholar 

  22. Ranbaxy Laboratories Ltd. XIMINO™ (minocycline hydrochloride) extended-release capsules: US prescribing information. 2015. https://www.fda.gov/. Accessed 16 Apr 2020.

  23. Medicis Pharmaceutical Corporation. SOLODYN® (minocycline hydrochloride) extended release tablets: US prescribing information. 2013. https://www.fda.gov/. Accessed 16 Apr 2020.

Download references

Acknowledgements

During the peer review process, the manufacturer of topical minocycline foam 4% was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Julia Paik.

Ethics declarations

Funding

The preparation of this review was not supported by any external funding.

Conflict of interest

Julia Paik is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.

Additional information

Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.12089649.

The manuscript was reviewed by:V. Bettoli, Department of Medical Sciences, O.U. of Dermatology, Azienda Ospedaliera-University of Ferrara, Cona, Italy; N. Bhatia, Therapeutics Clinical Research, San Diego, CA, USA; J.S. Weiss, Gwinnett Clinical Research Center, Snellville, GA, USA.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Paik, J. Topical Minocycline Foam 4%: A Review in Acne Vulgaris. Am J Clin Dermatol 21, 449–456 (2020). https://doi.org/10.1007/s40257-020-00523-1

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40257-020-00523-1

Navigation