Tacalcitol ointment in the treatment of psoriasis vulgaris:a multicentre, placebo-controlled, double-blind study on efficacy and safety

Kerkhof, P.C.M. van de; Werfel, T.; Haustein, U.‐F.; Luger, Thomas A.; Czarnetzki, Beate M.; Niemann, Reinhard; Plänitz-Stenzel, V.

doi:10.1046/j.1365-2133.1996.d01-1075.x

Cited by 60 publications

(55 citation statements)

References 15 publications

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“…Additionally facial and intertriginous lesions were not treated in the calcipotriol long-term studies in contrast to tacalcitol-treated patients where application to the face and flexures was allowed. Although the calcipotriol studies were twice as long and one had a considerably larger number of patients, the findings correspond well to previous reports where tacalcitol has been found to have a very good tolerability even on sensitive skin areas [10][11][12][15][16][17] and to be less irritating than calcipotriol [18].…”

Section: Discussionsupporting

confidence: 77%

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Tacalcitol Ointment for Long-Term Control of Chronic Plaque Psoriasis in Dermatological Practice

Lambert

Trompke²

2002

Dermatology

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Background: Various studies have shown the benefit of topical vitamin D₃ 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 µg/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.

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Section: Discussionsupporting

confidence: 77%

“…Even during long-term use no significant effect on calcium homeostasis was found, and tacalcitol was shown to be safe and well tolerated [8,9,11,12].…”

Section: Discussionmentioning

confidence: 99%

Tacalcitol Ointment for Long-Term Control of Chronic Plaque Psoriasis in Dermatological Practice

Lambert

Trompke²

2002

Dermatology

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“…Pharmacological doses of 1,25(OH) 2 D 3 induce hypercalcemia when administered systemically, which is a significant obstacle when considering its clinical application. However tacalcitol ointment and cream preparations have been prescribed successfully for the treatment of psoriasis [15,16,31]. In this case, administration via the topical route delivers a higher concentration of the drug to epidermal lesions [32] than could be achieved using a systemic route.…”

Section: Discussionmentioning

confidence: 99%

“…Although these observations make vitamin D 3 [14]. Tacalcitol is used to treat psoriasis vulgaris [15,16] and other keratinizing disorders, possibly by regulating the proliferation and differentiation of affected keratinocytes in psoriasis [14,17].…”

Section: Introductionmentioning

confidence: 99%

Tacalcitol, an Active Vitamin D<sub>3</sub>, Induces Nerve Growth Factor Production in Human Epidermal Keratinocytes

Fukuoka

Sakurai

Ohta

et al. 2001

Skin Pharmacol Physiol

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The human epidermal keratinocyte cell line K-TL-1, developed from a benign epidermal tumor, was cultured in the presence of the synthetic vitamin D₃ analogue tacalcitol [1α,24(R)-dihydroxyvitamin D₃] to assess the effects on the production of nerve growth factor (NGF). Confluent K-TL-1 cells were cultured with 10^–8M of tacalcitol. Supernatants and cell homogenates were collected and NGF concentrations were determined by enzyme-linked immunosorbent assay. The concentration of NGF in the supernatants of cultures treated with tacalcitol peaked within 24 h after the start of tacalcitol treatment and remained stable for 96 h. This NGF induction caused by tacalcitol was dose-dependent, showing an ED₅₀ between 10^–10 and 10^–9M. Induction of NGF mRNA expression by tacalcitol was also observed by RT-PCR, indicating that tacalcitol induced NGF expression through transcriptional activation. These results suggest that active vitamin D₃ could treat peripheral neuropathy by inducing NGF production in the skin.

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“…psoriasis [1][2][3]. Both VD 3 and RA are known ligands for nuclear receptors, the vitamin D receptor (VDR) and the retinoic acid/retinoic X receptors (RAR/RXR), respectively [4].…”

Section: Introductionmentioning

confidence: 99%

Vitamin D<sub>3</sub> and Its Synthetic Analogue Secocholestra-Trien-1,2,24-Triol Influence the Metabolism and the Isomerization of Retinoic Acid inHuman Keratinocytes

Jugert

Roos²,

Notzon³

1998

Skin Pharmacol Physiol

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Vitamin D and vitamin A acid share metabolic pathways thereby influencing their benefit as a given drug. Little is known concerning their metabolic interactions in epidermal cells. We compared the influence of 1,25-dihydroxycholecalciferol (vitamin D₃ – VD₃) and its synthetic analogue secocholestra-trien-1,3,24-triol (tacalcitol – TAC) in combination with different calcium concentrations (Ca) on the metabolism and the isomerization of retinoic acid (RA) in cultured primary human keratinocytes. After preincubation with 0.09, 0.6 and 1.2 mM Ca for 24 h, followed by the addition of 10^–6, 10^–8 or 10^–10 M VD₃ or TAC, we added 10^–5 M 13-cis-RA (isotretinoin). 24 h later, concentrations of RA isomers and oxidated RA metabolites were measured by RP-HPLC. VD₃ (10^–6 M) inhibited the isomerization of 13-cis-RA to all-trans-RA (tretinoin) and 9-cis-RA independently from the Ca concentration in the culture medium. 10^–6–10^–10 M TAC equally inhibit the 4-hydroxylation of all-trans-RA significantly (12.8 vs. 6.7% of total RA), thereby reducing the amount of irreversible inactivated 4-oxo-all-trans-RA, leading to a higher persistence of all-trans-RA, the active hormone. Both VD₃ and its analogue TAC influence the metabolism of RA, a well-known regulator of epithelial cell proliferation and differentiation processes, in two distinct ways. Further studies are necessary to test the hypothesis that the hormone activity of RA can be increased by concomitant treatment with VD₃ which prolongs the persistence of 13-cis-RA, and TAC elevating the intracellular concentration of all-trans-RA.

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Tacalcitol ointment in the treatment of psoriasis vulgaris:a multicentre, placebo-controlled, double-blind study on efficacy and safety

Cited by 60 publications

References 15 publications

Tacalcitol Ointment for Long-Term Control of Chronic Plaque Psoriasis in Dermatological Practice

Tacalcitol Ointment for Long-Term Control of Chronic Plaque Psoriasis in Dermatological Practice

Tacalcitol, an Active Vitamin D<sub>3</sub>, Induces Nerve Growth Factor Production in Human Epidermal Keratinocytes

Vitamin D<sub>3</sub> and Its Synthetic Analogue Secocholestra-Trien-1,2,24-Triol Influence the Metabolism and the Isomerization of Retinoic Acid inHuman Keratinocytes

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