Skip to main content
SpringerLink
Log in

Calcipotriol/Betamethasone Dipropionate Foam: A Review in Plaque Psoriasis

  • Adis Drug Evaluation
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

Calcipotriol/betamethasone dipropionate foam (Enstilar®) is a once-daily synthetic vitamin D3 analogue and synthetic corticosteroid fixed-dose combination foam formulation that is indicated for the topical treatment of plaque psoriasis in adults. In randomized, multicentre trials, treatment with calcipotriol/betamethasone dipropionate foam for 4 weeks resulted in greater proportions of patients achieving treatment success [of the body (i.e. trunk and/or limbs), as assessed by a physician] compared with 4 weeks’ treatment with the foam vehicle, individual components as foam, or calcipotriol/betamethasone dipropionate fixed-dose combination as an ointment, or 8 weeks’ treatment with the fixed-dose combination as a topical suspension. Treatment with calcipotriol/betamethasone dipropionate foam resulted in significantly lower modified psoriasis area and severity index scores and, where assessed, greater improvements from baseline to week 4 in itch-related sleep loss and health-related quality of life than its comparators; results were mixed for patient-assessed improvements in itch. Overall, adverse events were mostly mild or moderate in severity, and the most commonly reported treatment-related adverse events were application-site events. Notably, there were no reports of clinically relevant effects on calcium homeostasis or the hypothalamic-pituitary-adrenal axis. Calcipotriol/betamethasone dipropionate foam is a useful new option for patients with plaque psoriasis.

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

Access this article

Log in via an institution

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

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. World Health Organization. Global report on psoriasis. 2016. http://www.who.int. Accessed 12 Sep 2016.

  2. Boehncke W-H, Schön MP. Psoriasis. Lancet. 2015;386(9997):983–94.

    Article  CAS  PubMed  Google Scholar 

  3. American Academy of Dermatology. Psoriasis. 2016. https://www.aad.org. Accessed 12 Sep 2016.

  4. Hugh JM, Newman MD, Weinberg JM. The pathophysiology of psoriasis. In: Weinberg JM, Lebwohl M, editors. Advances in psoriasis: a multisystemic guide. London: Springer-Verlag; 2014. p. 1–7.

    Google Scholar 

  5. Grozdev I, Korman NJ. Psoriasis: epidemiology, potential triggers, disease course. In: Weinberg JM, Lebwohl M, editors. Advances in psoriasis: a multisystemic guide. London: Springer-Verlag; 2014. p. 27–37.

    Google Scholar 

  6. Laws PM, Young HS. Psoriasis and comorbidities. In: Weinberg JM, Lebwohl M, editors. Advances in psoriasis: a multisystemic guide. London: Springer-Verlag; 2014. p. 277–99.

    Google Scholar 

  7. Schreve BS, Boehncke W-H. Psoriasis. In: Adebajo A, Boehncke W-H, Gladman DD, Mease PJ, editors. Psoriatic arthritis and psoriasis: pathology and clinical aspects. Cham: Springer International Publishing; 2016. p. 129–37.

    Chapter  Google Scholar 

  8. Ohmatsu H, Krueger JG. Psoriasis. In: Kabashima K, editor. Immunology of the skin: basic and clinical sciences of skin immune responses. Tokyo: Springer Japan; 2016. p. 359–73.

    Chapter  Google Scholar 

  9. Kupetsky EA, Keller M. Psoriasis vulgaris: an evidence-based guide for primary care. J Am Board Fam Med. 2013;26(6):787–801.

    Article  PubMed  Google Scholar 

  10. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5):826–50.

    Article  PubMed  Google Scholar 

  11. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1):137–74.

    Article  PubMed  Google Scholar 

  12. Zschocke I, Mrowietz U, Karakasili E, et al. Non-adherence and measures to improve adherence in the topical treatment of psoriasis. J Eur Acad Dermatol Venereol. 2014;28(Suppl 2):4–9.

    Article  PubMed  Google Scholar 

  13. Augustin M, Radtke MA. Quality of life in psoriasis. In: Warren R, Menter A, editors. Handbook of psoriasis and psoriatic arthritis. Cham: Springer International Publishing; 2016. p. 101–16.

    Chapter  Google Scholar 

  14. Leo Pharma. Enstilar® (calcipotriene and betamethasone dipropionate) foam: US prescribing information. 2016. http://www.fda.gov. Accessed 12 Sep 2016.

  15. Leo Pharma. Enstilar® (calcipotriol/betamethasone dipropionate) cutaneous foam: UK summary of product characteristics. 2016. https://www.medicines.org.uk/emc. Accessed 12 Sep 2016.

  16. Leonardi C, Bagel J, Yamauchi P, et al. Efficacy and safety of calcipotriene plus betamethasone dipropionate aerosol foam in patients with psoriasis vulgaris-a randomized phase III study (PSO-FAST). J Drugs Dermatol. 2015;14(12):1468–77.

    CAS  PubMed  Google Scholar 

  17. Leo Pharma A/S. Leo Pharma receives scientific approval of Enstilar® for the treatment of psoriasis in EU. 2016. http://www.prnewswire.com. Accessed 12 Sep 2016.

  18. McCormack PL. Calcipotriol/betamethasone dipropionate: a review of its use in the treatment of psoriasis vulgaris of the trunk, limbs and scalp. Drugs. 2011;71(6):709–30.

    Article  CAS  PubMed  Google Scholar 

  19. Tajirian AL, Kircik L. Topical therapy I: corticosteroids and vitamin D analogues. In: Weinberg JM, Lebwohl M, editors. Advances in psoriasis: a multisystemic guide. London: Springer-Verlag; 2014. p. 63–72.

    Google Scholar 

  20. Lovato P, Norsgaard H, Tokura Y, et al. Calcipotriol and betamethasone dipropionate exert additive inhibitory effects on the cytokine expression of inflammatory dendritic cell-Th17 cell axis in psoriasis. J Dermatol Sci. 2016;81(3):153–64.

    Article  CAS  PubMed  Google Scholar 

  21. Queille-Roussel C, Olesen M, Villumsen J, et al. Efficacy of an innovative aerosol foam formulation of fixed combination calcipotriol plus betamethasone dipropionate in patients with psoriasis vulgaris. Clin Drug Investig. 2015;35(4):239–45.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  22. Lind M, Nielsen KT, Schefe LH, et al. Supersaturation of calcipotriene and betamethasone dipropionate in a novel aerosol foam formulation for topical treatment of psoriasis provides enhanced bioavailability of the active ingredients. Dermatol Ther (Heidelb). 2016;6(3):413–25.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Queille-Roussel C, Bang B, Clonier F, et al. Enhanced vasoconstrictor potency of the fixed combination calcipotriol plus betamethasone dipropionate in an innovative aerosol foam formulation vs. other corticosteroid psoriasis treatments. J Eur Acad Dermatol Venereol. 2016. doi:10.1111/jdv.13714.

    Google Scholar 

  24. Queille-Roussel C, Liljedahl M, Clonier F, et al. Phase 1 evaluation of the dermal safety of the fixed combination calcipotriene plus betamethasone dipropionate aerosol foam and foam vehicle [abstract no. 844 plus poster]. In: 73rd Annual Meeting of the AAD; 2015.

  25. Koo J, Tyring S, Werschler WP, et al. Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris-a randomized phase II study. J Dermatolog Treat. 2016;27(2):120–7.

    Article  CAS  PubMed  Google Scholar 

  26. Paul C, Stein Gold L, Cambazard F, et al. Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study. J Eur Acad Dermatol Venereol. 2016. doi:10.1111/jdv.13859.

    Google Scholar 

  27. Lebwohl M, Tyring S, Bukhalo M, et al. Fixed combination aerosol foam calcipotriene 0.005 % (Cal) plus betamethasone dipropionate 0.064% (BD) is more efficacious than Cal or BD aerosol foam alone for psoriasis vulgaris-a randomized, double-blind, multicenter, three-arm, phase 2 study. J Clin Aesthet Dermatol. 2016;9(2):34–41.

  28. Leonardi C, Bagel J, Yamauchi P, et al. Innovative fixed-combination calcipotriene 0.005%/betamethasone dipropionate 0.064% aerosol foam provides clinically relevant improvement in quality of life in psoriasis patients (PSO-FAST study) [abstract no. 2984024 plus poster]. In: 23rd World Congress of Dermatology; 2015.

  29. Paul C, Stein Gold L, Cambazard F, et al. More rapid improvement in quality of life with fixed combination calcipotriene plus betamethasone dipropionate aerosol foam versus topical suspension (PSO-ABLE study in patients with psoriasis vulgaris) [abstract no. 3712 plus poster]. In: 74th AAD Annual Meeting; 2016.

  30. Stein Gold L, Rosen M, Villumsen J. Associations between baseline disease characteristics and total amount of calcipotriene/betamethasone dipropionate aerosol foam used in patients with psoriasis vulgaris: post-hoc analysis from PSO-FAST [poster no. 3213]. In: 74th AAD Annual Meeting; 2016.

  31. Paul C, Stein Gold L, Cambazard F, et al. Fixed combination calcipotriene/betamethasone dipropionate aerosol foam has greater efficacy and similar tolerability versus topical suspension in patients with psoriasis vulgaris (phase III PSO-ABLE study) [poster no. 2980]. In: 34th Fall Clinical Dermatology Conference; 2015.

  32. European Medicines Agency. Daivobet article 30 referral: annexes I, II, III. 2011. http://www.ema.europa.eu. Accessed 12 Sep 2016.

  33. Stein Gold L, Lebwohl M, Menter A, et al. Aerosol foam formulation of fixed combination calcipotriene plus betamethasone dipropionate is highly efficacious in patients with psoriasis vulgaris: pooled data from three randomized controlled studies. J Drugs Dermatol. 2016;15(8):951–7.

  34. Menter A, Stein Gold L, Koo J, et al. Fixed combination aerosol foam formulation of calcipotriene plus betamethasone dipropionate is well tolerated in patients with psoriasis vulgaris: pooled data from three randomized controlled studies [abstract no. PA-21 plus poster]. In: 16th Annual Las Vegas Dermatology Seminar; 2015.

  35. Taraska V, Tuppal R, Olesen M, et al. A novel aerosol foam formulation of calcipotriol and betamethasone has no impact on HPA axis and calcium homeostasis in patients with extensive psoriasis vulgaris. J Cutan Med Surg. 2016;20(1):44–51.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  36. Mason AR, Mason J, Cork M, et al. Topical treatments for chronic plaque psoriasis (review). Cochrane Database Syst Rev. 2013. doi:10.1002/14651858.CD005028.pub3.

    Google Scholar 

  37. Carlsen KH, Olasz A, Carlsen KM, et al. Psoriasis and adherence to therapy: individual, treatment-related and general factors. In: Davis SA, editor. Adherence in dermatology. Cham: Springer International Publishing; 2016. p. 101–19.

    Chapter  Google Scholar 

Download references

Acknowledgments

During the peer review process, the manufacturer of calcipotriol/betamethasone dipropionate foam 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

  1. Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Esther S. Kim & James E. Frampton

Authors
  1. Esther S. Kim
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. James E. Frampton
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Esther S. Kim.

Ethics declarations

Funding

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

Conflict of interest

Esther Kim and James Frampton are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.

Additional information

The manuscript was reviewed by: L. Kircik, Indiana Medical Center, Indianapolis, IN, USA, Icahn School of Medicine at Mount Sinai, New York, NY, USA; A. Yen Moore, Baylor University Medical Center, Dallas, TX, USA; P. S. Yamauchi, Division of Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Kim, E.S., Frampton, J.E. Calcipotriol/Betamethasone Dipropionate Foam: A Review in Plaque Psoriasis. Drugs 76, 1485–1492 (2016). https://doi.org/10.1007/s40265-016-0643-7

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-016-0643-7

Keywords

Search

Navigation