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Clinical Drug Investigation

, Volume 32, Issue 9, pp 613–619 | Cite as

Comparison of the Antipsoriatic Effect and Tolerability of Calcipotriol-Containing Products in the Treatment of Psoriasis Vulgaris Using a Modified Psoriasis Plaque Test

  • Catherine Queille-Roussel
  • Vibeke Hoffmann
  • Cecilia Ganslandt
  • Klaus Krog Hansen
Original Research Article

Abstract

Background and Objective: In 1972, Dumas and Scholtz developed the psoriasis plaque test to evaluate the potency of local corticosteroids. Through further modification of this method, the efficacy between antipsoriatic products can be differentiated. This method allowed for the simultaneous application of several products to different test sites in the same psoriasis patient. The objective of this current study was to compare the antipsoriatic effect of six topical products using a modified version of the original psoriasis plaque test with emphasis on the predictive capacity of this model. Validation of the use of immunohistochemical and histological scoring of biopsy material, in conjunction with clinical scoring, in the prediction of antipsoriatic effects was an additional objective.

Methods: This study was a single-centre, investigator-blinded, within-subject randomized, active- and vehicle-controlled, intraindividual comparison of six topical products in patients with psoriasis vulgaris. The products evaluated were calcipotriol ointment (50 μg/g); calcipotriol cream (50 μg/g); two-compound ointment (calcipotriol 50 μg/g; betamethasone dipropionate 0.5 mg/g); two-compound gel (calcipotriol 50 μg/g; betamethasone dipropionate 0.5 mg/g) [all in their marketed formulations]; an investigational ointment (calcipotriol 25 μg/g; hydrocortisone 10 mg/g); and a vehicle control. Psoriasis patients (≥18 years of age; n = 24) received simultaneous topical application of each of the products 6 days a week for a period of 21 days, at different test sites located on psoriasis plaques. Clinical assessment of the test sites was completed twice a week. Test site biopsies were taken at the final visit for histological analysis. The primary endpoint was the absolute change in total clinical score (TCS; erythema, scaling and infiltration) from baseline.

Results: For all products, the change in TCS correlated well with changes in histological and immunohistochemical values. The two-compound ointment and the two-compound gel both resulted in a large and significant reduction in TCS. Calcipotriol ointment and the calcipotriol/hydrocortisone ointment were less effective, although they were still more effective than the calcipotriol cream and the ointment vehicle.

Conclusion: This study has demonstrated that the modified psoriasis plaque test can provide a relatively quick and effective method to evaluate the anti-psoriatic effect of several topical treatments in small cohorts and that, by combining clinical scoring and histological assessment, a more accurate prediction of the antipsoriatic effect can be made. The two-compound formulations (ointment and gel) had a comparable antipsoriatic effect, which was superior to the other products tested. Furthermore, these data indicate that the gel formulation could provide an alternative effective treatment option to the well established two-compound ointment for psoriasis patients.

Clinical Trial Registration: Registered as EudraCT no: 2007-005463-10.

Keywords

Psoriasis Test Site Psoriasis Plaque Psoriasis Patient Calcipotriol 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

This is a LEO Pharma sponsored study, fully financed by LEO Pharma A/S. VH, CG and KKH are employees of LEO Pharma A/S. The authors would like to thank Magali Procacci-Babled (CPCAD) for her valuable technical expertise in the model and Jenny Geatrell and Michael Maddalena (Watermeadow Medical) for their writing and editorial assistance, which was supported by LEO Pharma.

References

  1. 1.
    Griffiths CEM, Barker JNWN. Pathogenesis and clinical features of psoriasis. Lancet 2007; 370(9583): 263–71PubMedCrossRefGoogle Scholar
  2. 2.
    Dumas KJ, Scholtz JR. The psoriasis bio-assay for topical corticosteroid activity. Acta Derm Venereol 1972; 52(1): 43–8PubMedGoogle Scholar
  3. 3.
    Katz M, Shaikh Z, Maibach HI. Scholtz-Dumas psoriasis small plaque bioassay. J Dermatol Treat 2000; 11(1): 15–9Google Scholar
  4. 4.
    Kvist PH, Svensson L, Hagberg O, et al. Comparison of the effects of vitamin D products in a psoriasis plaque test and a murine psoriasis xenograft model. J Transl Med 2009; 7: 107PubMedCrossRefGoogle Scholar
  5. 5.
    Kragballe K, Noerrelund KL, Lui H, et al. Efficacy of once-daily treatment regimens with calcipotriol/betamethasone dipropionate ointment and calcipotriol ointment in psoriasis vulgaris. Br J Dermatol 2004; 150(6): 1167–73PubMedCrossRefGoogle Scholar
  6. 6.
    Guenther L, Van de Kerkhof PC, Snellman E, et al. Efficacy and safety of a new combination of calcipotriol and beta-methasone dipropionate (once or twice daily) compared to calcipotriol (twice daily) in the treatment of psoriasis vulgaris: a randomized, double-blind, vehicle-controlled clinical trial. Br J Dermatol 2002; 147(2): 316–23PubMedCrossRefGoogle Scholar
  7. 7.
    Kaufmann R, Bibby AJ, Bissonnette R, et al. A new calcipotriol/betamethasone dipropionate formulation (Daivobet) is an effective once-daily treatment for psoriasis vulgaris. Dermatology 2002; 205(4): 389–93PubMedCrossRefGoogle Scholar
  8. 8.
    Fleming C, Ganslandt C, Guenther L, et al. Calcipotriol plus betamethasone dipropionate gel compared with its active components in the same vehicle and the vehicle alone in the treatment of psoriasis vulgaris: a randomised, parallel group, double-blind, exploratory study. Eur J Dermatol 2010; 20(4): 465–71PubMedGoogle Scholar
  9. 9.
    Langley RG, Gupta A, Papp K, et al. Calcipotriol plus betamethasone dipropionate gel compared with tacalcitol ointment and the gel vehicle alone in patients with psoriasis vulgaris: a randomised, controlled clinical trial. Dermatology 2011; 222(2): 148–56PubMedCrossRefGoogle Scholar
  10. 10.
    Ortonne JP, Noerrelund KL, Papp K, et al. Comparison of two different dose combinations of calcipotriol/hydrocortisone ointment used once daily for the treatment of psoriasis vulgaris on the face and body. Eur J Dermatol 2010; 20(5): 585–9PubMedGoogle Scholar
  11. 11.
    Zivkovich AH, Feldman SR. Are ointments better than other vehicles for corticosteroid treatment of psoriasis? J Drugs Dermatol 2009; 8(6): 570–2PubMedGoogle Scholar
  12. 12.
    Hol K. European study into the opinions of psoriasis patients and physicians. 19th Congress of the European Academy of Dermatology and Venereology (EADV), 6–10 October 2010, Gothenburg, Sweden; p. 573Google Scholar
  13. 13.
    Hol K. Patient preference for topical psoriasis formulations. 19th Congress of the European Academy of Dermatology and Venereology (EADV), 6–10 October 2010, Gothenburg, Sweden; p. 572Google Scholar

Copyright information

© Springer International Publishing AG 2012

Authors and Affiliations

  • Catherine Queille-Roussel
    • 1
  • Vibeke Hoffmann
    • 2
  • Cecilia Ganslandt
    • 2
  • Klaus Krog Hansen
    • 2
  1. 1.CPCAD, Centre de Pharmacologie Clinique Appliquée à la DermatologieHôpital de l’Archet 2Nice Cedex 3France
  2. 2.LEO Pharma A/SBallerupDenmark

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