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Tacalcitol ointment in the treatment of psoriasis vulgaris: a multicentre, placebo-controlled, double-blind study on efficacy and safety.
Br J Dermatol. 1996 Nov; 135(5):758-65.BJ

Abstract

Tacalcitol is a vitamin D analogue which ahs been developed for the therapy of psoriasis vulgaris. The treatment with a twice daily application of 2 micrograms/g ointment is efficacious and safe in Japanese patients. The objective of this randomized, placebo-controlled, intraindividual right-left comparison was to investigate the efficacy and safety of 8 weeks' therapy with a once daily application of a 4 micrograms/g tacalcitol ointment in Caucasian psoriatics. The data on 122 male and female patients were analysed. The score sum of erythema, infiltration and desquamation was influenced significantly more by tacalcitol ointment than by placebo (P < 0.0001) at every control point, starting from week 2. With regard to the individual symptoms of desquamation, infiltration and erythema, the treatment with tacalcitol was also superior to placebo treatment beginning at week 2. Qualitatively, the same results were obtained with the preference assessment of both treated body sides and also the global assessments of efficacy and benefit. Symptoms of local skin irritation which may be related to the active compound or the ointment base were reported by 12.3% of patients. In only one patient, irritation required discontinuation of tacalcitol treatment. Laboratory criteria, including serum calcium, serum phosphate and serum levels of calcitonin, parathormone, 1 alpha, 24-dihydroxyvitamin D3 and 25-hydroxyvitamin D3, did not reveal any changes of clinical relevance during or after treatment. Furthermore, the global assessment of tolerance was good or very good in more than 90% of cases. The results of this study demonstrate that the once daily application of a 4 micrograms/g tacalcitol ointment is an efficacious therapy for psoriasis vulgaris in Caucasian patients, and that its tolerance is good, wherever the lesion is located, including on the face.

Authors+Show Affiliations

University Hospital Nijmegen, Department of Dermatology, The Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

8977677

Citation

Van de Kerkhof, P C., et al. "Tacalcitol Ointment in the Treatment of Psoriasis Vulgaris: a Multicentre, Placebo-controlled, Double-blind Study On Efficacy and Safety." The British Journal of Dermatology, vol. 135, no. 5, 1996, pp. 758-65.
Van de Kerkhof PC, Werfel T, Haustein UF, et al. Tacalcitol ointment in the treatment of psoriasis vulgaris: a multicentre, placebo-controlled, double-blind study on efficacy and safety. Br J Dermatol. 1996;135(5):758-65.
Van de Kerkhof, P. C., Werfel, T., Haustein, U. F., Luger, T., Czarnetzki, B. M., Niemann, R., & Plänitz-Stenzel, V. (1996). Tacalcitol ointment in the treatment of psoriasis vulgaris: a multicentre, placebo-controlled, double-blind study on efficacy and safety. The British Journal of Dermatology, 135(5), 758-65.
Van de Kerkhof PC, et al. Tacalcitol Ointment in the Treatment of Psoriasis Vulgaris: a Multicentre, Placebo-controlled, Double-blind Study On Efficacy and Safety. Br J Dermatol. 1996;135(5):758-65. PubMed PMID: 8977677.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tacalcitol ointment in the treatment of psoriasis vulgaris: a multicentre, placebo-controlled, double-blind study on efficacy and safety. AU - Van de Kerkhof,P C, AU - Werfel,T, AU - Haustein,U F, AU - Luger,T, AU - Czarnetzki,B M, AU - Niemann,R, AU - Plänitz-Stenzel,V, PY - 1996/11/1/pubmed PY - 1996/11/1/medline PY - 1996/11/1/entrez SP - 758 EP - 65 JF - The British journal of dermatology JO - Br J Dermatol VL - 135 IS - 5 N2 - Tacalcitol is a vitamin D analogue which ahs been developed for the therapy of psoriasis vulgaris. The treatment with a twice daily application of 2 micrograms/g ointment is efficacious and safe in Japanese patients. The objective of this randomized, placebo-controlled, intraindividual right-left comparison was to investigate the efficacy and safety of 8 weeks' therapy with a once daily application of a 4 micrograms/g tacalcitol ointment in Caucasian psoriatics. The data on 122 male and female patients were analysed. The score sum of erythema, infiltration and desquamation was influenced significantly more by tacalcitol ointment than by placebo (P < 0.0001) at every control point, starting from week 2. With regard to the individual symptoms of desquamation, infiltration and erythema, the treatment with tacalcitol was also superior to placebo treatment beginning at week 2. Qualitatively, the same results were obtained with the preference assessment of both treated body sides and also the global assessments of efficacy and benefit. Symptoms of local skin irritation which may be related to the active compound or the ointment base were reported by 12.3% of patients. In only one patient, irritation required discontinuation of tacalcitol treatment. Laboratory criteria, including serum calcium, serum phosphate and serum levels of calcitonin, parathormone, 1 alpha, 24-dihydroxyvitamin D3 and 25-hydroxyvitamin D3, did not reveal any changes of clinical relevance during or after treatment. Furthermore, the global assessment of tolerance was good or very good in more than 90% of cases. The results of this study demonstrate that the once daily application of a 4 micrograms/g tacalcitol ointment is an efficacious therapy for psoriasis vulgaris in Caucasian patients, and that its tolerance is good, wherever the lesion is located, including on the face. SN - 0007-0963 UR - https://www.unboundmedicine.com/medline/citation/8977677/Tacalcitol_ointment_in_the_treatment_of_psoriasis_vulgaris:_a_multicentre_placebo_controlled_double_blind_study_on_efficacy_and_safety_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&amp;sid=nlm:pubmed&amp;issn=0007-0963&amp;date=1996&amp;volume=135&amp;issue=5&amp;spage=758 DB - PRIME DP - Unbound Medicine ER -