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Dermatology. 2017;233(6):425-434. doi: 10.1159/000486700. Epub 2018 Mar 2.

Prospective, Observational, Non-Interventional, Multicentre Study on the Efficacy and Tolerability of a New Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients with Plaque Psoriasis under Daily Practice Conditions.

Author information

1
Psoriasis Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany.
2
Private Practice for Dermatology, Aesthetic Medicine, Transsexual Medicine, Leipzig, Germany.
3
LEO Pharma GmbH, Neu-Isenburg, Germany.
4
Department of Dermatology, Venereology and Allergology and Outpatient Clinic of the Essen University Hospital, Essen, Germany.

Abstract

BACKGROUND/AIMS:

To assess the efficacy and tolerability of the new aerosol foam of calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g (Cal/BD foam, Enstilar®) in psoriasis vulgaris under daily practice conditions.

METHODS:

410 adult psoriasis patients (56% male) from 87 German sites were enrolled in a 4-week, open-label, prospective, non-controlled, observational, non-interventional study.

RESULTS:

At baseline, patients presented with a psoriasis severity of mild (41.81%), moderate (49.63%), and severe (8.31%) assessed by an investigator global assessment (IGA). After 4 weeks of treatment, 49% of the patients achieved an IGA of clear/almost clear. The mean affected body surface area was reduced from 12.91 to 7.55%, the PASI from 10.4 to 5.2 (p < 0.0001). 43% of the patients with severe IGA achieved treatment success (IGA = 0/1 and ≥2-step improvement). 93% of the patients did not show any adverse events.

CONCLUSION:

The new Cal/BD foam showed a convincing efficacy and tolerability profile in daily practice, particularly in patients with severer disease manifestations.

KEYWORDS:

Fixed combination; Quality of life; Real-world evidence; Topical therapy

PMID:
29502110
DOI:
10.1159/000486700
[Indexed for MEDLINE]
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