[Treatment of scalp psoriasis. An effective and safe tacalcitol emulsion]. / Behandlung der Kopfhaut-Psoriasis. Gute Wirksamkeit und Sicherheit durch Tacalcitol-Emulsion.

BACKGROUND: The scalp is a problematic area in psoriasis where treatment is often difficult. The lesions often extend beyond the hairline to involve the forehead, neck and sensitive facial skin. Topical corticosteroids and potentially irritant topical preparations have only limited utility in these sensitive areas. Most of the patients additionally suffer from psychosocial problems due to the visibility of lesions. OBJECTIVE: The aim of this multicenter, prospective, randomized, double-blind study, was to assess efficacy, safety and tolerability of once daily tacalcitol emulsion (4 micro g/g) compared to placebo in the treatment of scalp psoriasis. METHODS: To determine efficacy, safety and tolerability, 273 patients with mild to moderate scalp psoriasis were treated over a 8-week period. Response to treatment was evaluated using the sum score of erythema, infiltration and scaling. Global improvement of psoriasis was rated by the investigators and the patients using a 5-point scale. In addition the single scores of erythema, infiltration and scaling were assessed by the investigators, and the patients were asked to evaluate the intensity of itching and scaling over the treatment period. RESULTS: Tacalcitol was significantly superior to placebo in reducing the severity of scalp psoriasis. At the end of the study, the median sum score decreased by 53% in the tacalcitol group and was significantly better than placebo with 30% (p<0.0001). Global assessment of improvement was significantly greater in the tacalcitol group in both investigator and patient evaluation. 80% of patients on tacalcitol showed improvement to clearance and was statistically significant better than placebo (p <0.0001) in the investigator rating after 8 weeks. Tacalcitol was significantly superior to placebo in reducing erythema, scaling and infiltration, and in the patient assessment in reducing scalp scaling and itching. Treatment was very well tolerated. Local reactions were transient and uncommon. Their incidence was similar in both treatment groups. No serious side effects were reported, including those relating to calcium homeostasis or vitamin D(3) metabolism. No changes in mean levels of serum calcium, parathyroid hormone (PTH), calcitriol and in 24h-urinary excretion were observed. CONCLUSION: The results of this study indicate that topical application of tacalcitol (4 micro g/g) emulsion once daily is an effective, safe and very well- tolerated treatment for scalp psoriasis.

Tacalcitol ointment for long-term control of chronic plaque psoriasis in dermatological practice.

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.

Long-term efficacy and safety of tacalcitol ointment in patients with chronic plaque psoriasis.

BACKGROUND: As psoriasis patients often require continuous treatment optimal therapy has to provide efficacy and a good safety profile over the long term. OBJECTIVES: The aim of this multicentre study was to assess the efficacy, safety and tolerability of tacalcitol (4 microg g(-1)) ointment (Curatoderm, Hermal, Reinbek, Germany) applied once daily over a treatment period of 18 months. PATIENTS AND METHODS: Efficacy parameters were Psoriasis Area Severity Index (PASI), based on summed scores of erythema, infiltration and scaling and total body surface involvement (TBI). Safety assessment included serum levels of calcium, parathyroid hormone, calcitonin, 1,25-dihydroxy vitamin D3 (calcitriol); urinary calcium, creatinine, calcium/creatinine ratio in spot and 24-h urine and urinary alpha(1)-microglobulin. A group of 304 patients with chronic plaque psoriasis, covering between 7% and 20% of the body surface area was included for the initial treatment phase of 3 months. Of the 257 patients who completed the initial 3 months, 197 patients continued in a second treatment phase of 15 months. RESULTS: Tacalcitol treatment proved to be effective in reducing the severity of psoriasis and maintained therapeutic response over the study period. The median PASI fell from 9.5 to 4 .6 at month 3 and to 3.25 at month 18 (P < 0.0001). The median improvement in TBI was 30% at month 3 and 50% at month 18. In no patient was there any relevant disturbance of calcium homeostasis. There were no significant changes in mean values of serum calcium, parathyroid hormone and calcitriol. Additionally no significant changes in 24-h urinary excretion evaluation were observed. There was no correlation between levels of serum calcium or urinary calcium and amount of tacalcitol ointment used, even in the patients requiring the largest amounts of ointment (up to 13 g day(-1) and up to 20% of body area affected). Treatment was generally well tolerated and there were no serious or unexpected adverse events reported. However, discontinuation of treatment as a result of skin irritation was seen in 5.9% of patients. The greatest frequency of cutaneous side-effects occurred during initial treatment and the incidence decreased markedly as the treatment was well-tolerated with continued use. CONCLUSIONS: Tacalcitol ointment once daily was demonstrated to be efficacious, safe and well tolerated in the long-term control of plaque psoriasis in patients with up to 20% body surface involvement.