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Randomized Controlled Trial
. 2008;217(4):321-8.
doi: 10.1159/000155642. Epub 2008 Sep 12.

A study of the safety and efficacy of calcipotriol and betamethasone dipropionate scalp formulation in the long-term management of scalp psoriasis

T A Luger  1 , F Cambazard, F G Larsen, M Bourcier, G Gupta, F Clonier, P Kidson, N H Shear
Affiliations
Randomized Controlled Trial

A study of the safety and efficacy of calcipotriol and betamethasone dipropionate scalp formulation in the long-term management of scalp psoriasis

T A Luger et al. Dermatology. 2008.

Abstract

Background: Effective and safe products are needed for long-term management of scalp psoriasis. This study investigated the long-term safety and efficacy of a two-compound formulation (calcipotriol 50 microg/g plus betamethasone dipropionate 0.5 mg/g) for scalp psoriasis.

Methods: In this 52-week, international, double-blind study, 869 patients with moderate-to-severe scalp psoriasis were randomized to either a two-compound scalp formulation (n = 429) or calcipotriol (n = 440).

Results: Adverse drug reactions were less frequent in the two-compound group compared with the calcipotriol group (17.2 vs. 29.5%; p < 0.001). Incidences of adverse events possibly associated with long-term corticosteroid use were low in both the two-compound (2.6%) and the calcipotriol (3.0%) groups. Disease was satisfactorily controlled in 92.3% of visits in the two-compound group versus 80.0% in the calcipotriol group (p < 0.001).

Conclusion: The two-compound scalp formulation demonstrated a high level of safety and efficacy in long-term management of scalp psoriasis.

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Figures

Fig. 1.
Fig. 1.
Patient disposition throughout the study.
Fig. 2.
Fig. 2.
Patients withdrawing due to unacceptable treatment effect (cumulative number).
Fig. 3.
Fig. 3.
Number of patients with satisfactorily controlled disease (‘absence of disease’, ‘very mild disease’ or ‘mild disease’) at each visit (Investigator's Global Assessment of disease severity; full analysis set).
See this image and copyright information in PMC

References

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