Placebo-controlled evaluation of the irritant potential of tacalcitol (1α, 24-dihydroxyvitamin D3) in healthy volunteers

Contact Dermatitis

Volumn 42, Issue 5, 2000, Pages 260-263

  Schlotmann, K ^a   Ortland, C ^b   Neumann, N J ^a   Ruzicka, T ^a   Lehmann, P ^a  

^a HEINRICH HEINE UNIVERSITY   (Germany)

^b Hermal   (Germany)

Author keywords

Irritation; Medicaments; Occlusive testing; Tacalcitol; Vitamin D3 analogues

Indexed keywords

ALKALI; COLECALCIFEROL DERIVATIVE; DIMETHYL SULFOXIDE; DRUG VEHICLE; IRRITANT AGENT; PLACEBO; SODIUM HYDROXIDE; TACALCITOL;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG FORMULATION; ERYTHEMA; FEMALE; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; OCCLUSION; OINTMENT; PSORIASIS; RANDOMIZED CONTROLLED TRIAL; SKIN IRRITATION; SKIN WATER LOSS; VOLUNTEER;

ADMINISTRATION, TOPICAL; ADULT; DERMATOLOGIC AGENTS; DIHYDROXYCHOLECALCIFEROLS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ERYTHEMA; EVALUATION STUDIES; FEMALE; HUMANS; IRRITANTS; MALE; MIDDLE AGED; OINTMENTS; PSORIASIS; SEVERITY OF ILLNESS INDEX;

EID: 0034005596     PISSN: 01051873     EISSN: None     Source Type: Journal    
DOI: 10.1034/j.1600-0536.2000.042005260.x     Document Type: Article

References (18)

1. 1. Kragballe K. Treatment of psoriasis with calcipotriol and other vitamin D analogues. J Am Acad Dermatol 1992: 27: 1001-1008.
2. 2. Jürgensen H J. Calcipotriol ointment used as monotherapy for the treatment of psoriasis vulgaris. Abstract Satellite Symposium of the 3rd Congress of the European Academy of Dermatology and Venereology, 1993.
3. 3. Van de Kerkhof P C M. Biological activity of vitamin D analogues in the skin, with special reference to antipsoriatic mechanisms. Br J Dermatol 1993: 132: 675-682.
4. 4. Van de Kerkhof P C M, Werfel T, Haustein U F, Luger T, Czarnetzki B M, Niemann R, Plänitz-Stenzel V. Tacalcitol ointment in the treatment of psoriasis vulgaris: a multicentre, placebo-controlled, double-blind study on efficacy and safety. Br J Dermatol 1996: 135: 758-765.
5. 5. Kimura H, Nishiyama S, Nakamizo Y et al. Investigation of the usefulness of TV-02 ointment for patients with psoriasis - right and left comparison test with betamethasone valerate ointment. Western Jpn Dermatol 1989: 51: 963-969.
6. 6. Kimura H, Nishiyama S, Nakamizo Y et al. Investigation of the clincal effects of TV-02 ointment on psoriasis. Western Jpn Dermatol 1989: 51: 970-979.
7. 7. Eto M, Nishiyama S, Nakamizo Y et al. Study on the efficacy of TV-02 ointment for psoriasis - results of a double-blind comparative clinical study on the left and right sides with a placebo (ointment base) as a control. Nishinihon J Dermatol 1991: 53: 1252-1261.
8. 8. Nishimura M, Hori Y, Nishiyama S, Nakamizo Y. Topical 1α,24 (R)-dihydroxyvitamin D3 for the treatment of psoriasis. Review of the literature. Eur J Dermatol 1993: 3: 255-261.
9. 9. Arafat S M, Turner R J, Marks R. The irritant effect of topically applied vitamin D3 analogue (calcipotriol). A placebo controlled, double blind, randomised study. Br J Dermatol 1995: 133: 36.
10. 3 analogue calcipotriol. Skin Pharmakol 1995: 8: 40.
11. 11. Fullerton A, Serup J. Topical D-vitamins: multiparametric comparison of the irritant potential of calcipotriol, tacalcitol and calcitriol in a hairless guinea pig model. Contact Dermatitis 1997: 36: 184-190.
12. 12. Fitzpatrick T B. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol 1988: 124: 869-871.
13. 13. Lehmann P, Hölzle E, Melnik B, Plewig G. Effects of ultraviolet A and B on the skin barrier: a functional, electron microscopic and lipid biochemical study. Photodermatol Photoimmunol Photomed 1991: 8: 129-134.
14. 14. Locher G. Permeabilitätsprüfung der Haut Ekzemkranker und Hautgesunder für den neuen Indikator Nitrazingelb "Geigy", Modifizierung der Alkaliresistenzprobe, pH-Verlauf in der Tiefe des stratum corneum. Dermatologica 1962: 124: 159-182.
15. 15. Ummenhofer B. Zur Methodik der Alkaliresistenzprüfung. Dermatosen 1983: 28: 104-109.
16. 16. Frosch P. Hautirritation und empfindliche Haut. Grosse Scripta 7, Berlin: Grosse, 1985: 31-33.
17. 17. Fullerton A, Avnstorp C, Agner T, Dahl J C, Olsen L O, Serup J. Patch test study with calcipotriol ointment in different patient groups including psoriatic patients with and without adverse dermatitis. Acta Dermato-venereologica 1996: 76: 194-202.
18. 18. Effendy I, Kwangsukstith C, Chiappe M, Maibach H I. Effects of calcipotriol on stratum corneum barrier function, hydration and cell renewal in humans. Br J Dermatol 1996: 135: 545-549.