J Lambert1, C Trompke. 1. Department of Dermatology, University of Antwerp, Belgium. Julien.Lambert@uza.uia.ac.be
Abstract
BACKGROUND: Various studies have shown the benefit of topical vitamin D(3) analogues in the treatment of mild to moderate plaque psoriasis. OBJECTIVE: Assessment of the efficacy, tolerability and safety of tacalcitol ointment in the long-term treatment of chronic plaque psoriasis in daily dermatological practice. DESIGN AND METHODS: In this open, multicentre, clinical phase IV study with a pre/post comparison design, 157 patients with chronic plaque psoriasis were included. Patients showing chronic plaque psoriasis, covering 7-20% of their body area, were treated with tacalcitol ointment (4 microg/g, Curatoderm) once daily and were assessed at baseline and monthly during the 6-month treatment period. The efficacy parameter psoriasis area and severity index (PASI) and total body surface involvement were assessed at each visit. Laboratory parameters were assessed at the beginning and at the end of the study. Adverse events were recorded at each visit. RESULTS: The mean PASI score decreased by 67%, and a marked reduction in sum scores of erythema, infiltration and desquamation was detected. The body area affected declined by 33% from 13.3 to 8.8%. There were no changes in laboratory parameters, and no case of hypercalcaemia was observed. No serious adverse events occurred during the study period. The recorded local side-effects were usually transient and mainly mild. CONCLUSION: Tacalcitol ointment is safe, well tolerated and provides a further option for patients with psoriasis up to 20% body surface affected. Tacalcitol treatment can be recommended as effective therapy for long-term control of chronic plaque psoriasis in dermatological practice. Copyright 2002 S. Karger AG, Basel
BACKGROUND: Various studies have shown the benefit of topical vitamin D(3) analogues in the treatment of mild to moderate plaque psoriasis. OBJECTIVE: Assessment of the efficacy, tolerability and safety of tacalcitol ointment in the long-term treatment of chronic plaque psoriasis in daily dermatological practice. DESIGN AND METHODS: In this open, multicentre, clinical phase IV study with a pre/post comparison design, 157 patients with chronic plaque psoriasis were included. Patients showing chronic plaque psoriasis, covering 7-20% of their body area, were treated with tacalcitol ointment (4 microg/g, Curatoderm) once daily and were assessed at baseline and monthly during the 6-month treatment period. The efficacy parameter psoriasis area and severity index (PASI) and total body surface involvement were assessed at each visit. Laboratory parameters were assessed at the beginning and at the end of the study. Adverse events were recorded at each visit. RESULTS: The mean PASI score decreased by 67%, and a marked reduction in sum scores of erythema, infiltration and desquamation was detected. The body area affected declined by 33% from 13.3 to 8.8%. There were no changes in laboratory parameters, and no case of hypercalcaemia was observed. No serious adverse events occurred during the study period. The recorded local side-effects were usually transient and mainly mild. CONCLUSION:Tacalcitol ointment is safe, well tolerated and provides a further option for patients with psoriasis up to 20% body surface affected. Tacalcitol treatment can be recommended as effective therapy for long-term control of chronic plaque psoriasis in dermatological practice. Copyright 2002 S. Karger AG, Basel