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Clin Drug Investig. 2017 Apr;37(4):355-361. doi: 10.1007/s40261-016-0489-5.

Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam Compared with Betamethasone 17-Valerate-Medicated Plaster for the Treatment of Psoriasis.

Author information

1
Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital L'Archet 2, 06202, Nice Cedex 3, France. catherine.queille-roussel@skinpharma.fr.
2
LEO Pharma A/S, Ballerup, Denmark.
3
LEO Pharma (Laboratoires LEO), Voisins Le Bretonneux, France.
4
Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital L'Archet 2, 06202, Nice Cedex 3, France.
5
Service de Dermatologie, University Hospital of Nice, Nice, France.

Abstract

BACKGROUND:

Fixed combination calcipotriol as hydrate (Cal) 50 µg/g plus betamethasone as dipropionate (BD) 0.5 mg/g aerosol foam is an alcohol-free treatment for psoriasis. Betamethasone 17-valerate 2.25 mg (BV)-medicated plasters are recommended for treating psoriasis plaques localized in difficult-to-treat (DTT; elbow, knee, anterior face of the tibia) areas.

OBJECTIVE:

The aim of this study was to compare the efficacy of Cal/BD foam with BV-medicated plaster in patients with plaque psoriasis.

METHODS:

In this phase IIa, randomized, single-center, investigator-blinded, 4-week study, both Cal/BD foam and BV-medicated plaster were applied once daily to six test sites (three for each treatment). The primary efficacy endpoint was absolute change in total clinical score (TCS; sum of erythema, scaling, and infiltration); secondary endpoints were changes from baseline in each individual clinical score, ultrasonographic changes (total skin and echo-poor band thickness), and safety; and post hoc analysis was change from baseline in TCS on DTT areas.

RESULTS:

Thirty-five patients were included. Least-squares mean change in TCS from baseline was significantly greater for Cal/BD foam (-5.8) than BV-medicated plaster (-3.7; difference -2.2; 95% confidence interval -2.6 to -1.8; p < 0.001); greater changes for Cal/BD foam were observed from day 8 for each clinical sign. Absolute total skin and echo-poor band thickness change was significantly greater for Cal/BD foam than for BV-medicated plaster (both p < 0.001). Post hoc analyses showed that Cal/BD foam was significantly more effective than BV-medicated plaster on DTT areas after 4 weeks (p < 0.001), and both treatments were well tolerated.

CONCLUSION:

Cal/BD foam demonstrated superior efficacy versus BV-medicated plasters, including on DTT areas, in patients with plaque psoriasis.

CLINICAL TRIAL REGISTRATION NUMBER:

NCT02518048.

PMID:
27995521
PMCID:
PMC5346111
DOI:
10.1007/s40261-016-0489-5
[Indexed for MEDLINE]
Free PMC Article

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