Calcipotriol plus betamethasone dipropionate gel compared with tacalcitol ointment and the gel vehicle alone in patients with psoriasis vulgaris: A randomized, controlled clinical trial

Dermatology

Volumn 222, Issue 2, 2011, Pages 148-156

  Langley, Richard G B ^a   Gupta, Aditya ^b   Papp, Kim ^d   Wexler, Denise ^c   Østerdal, Marie Louise ^f   Çurčić, Duica ^e  

^a DALHOUSIE UNIVERSITY   (Canada)

^b MEDIPROBE RESEARCH INC   (Canada)

^c Wellington Dermatology Association   (Canada)

^d K Papp Clinical Research   (Canada)

^e LEO Pharma Inc   (Canada)

^f LEO PHARMA A S   (Denmark)

Author keywords

Betamethasone dipropionate; Calcipotriol; Combination therapy; Daivobet Dovobet gel; Psoriasis vulgaris; Randomized controlled trial; Topical treatment

Indexed keywords

BETAMETHASONE DIPROPIONATE PLUS CALCIPOTRIOL; TACALCITOL;

ADULT; AGED; APPLICATION SITE BURNING; APPLICATION SITE DRYNESS; APPLICATION SITE PRURITUS; ARTICLE; BURNING SENSATION; CLINICAL ASSESSMENT; COMPARATIVE STUDY; DISEASE SEVERITY; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG WITHDRAWAL; DRY SKIN; ERYTHEMA; FEMALE; FOLLICULITIS; GEL; HUMAN; INVESTIGATOR GLOBAL ASSESSMENT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OINTMENT; PARALLEL DESIGN; PATIENT COMPLIANCE; PRIORITY JOURNAL; PROSPECTIVE STUDY; PSORIASIS; PSORIASIS AREA AND SEVERITY INDEX; PSORIASIS VULGARIS; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; SKIN BURNING SENSATION; SKIN EXFOLIATION; SKIN IRRITATION; SKIN PRURITUS; TREATMENT OUTCOME;

ADULT; BETAMETHASONE; CALCITRIOL; DERMATOLOGIC AGENTS; DIHYDROXYCHOLECALCIFEROLS; DRUG COMBINATIONS; FEMALE; GELS; HUMANS; MALE; MIDDLE AGED; OINTMENT BASES; PHARMACEUTICAL VEHICLES; PSORIASIS; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 79955677290     PISSN: 10188665     EISSN: None     Source Type: Journal    
DOI: 10.1159/000323408     Document Type: Article

References (22)

1. Berth-Jones J: Psoriasis. Medicine 2009; 37: 235-241.
2. Lowes MA, Bowcock AM, Krueger JG: Pathogenesis and therapy of psoriasis. Nature 2007; 445: 866-873.
3. Nestle FO, Kaplan DH, Barker J: Mechanisms of disease: psoriasis. N Engl J Med 2009; 361: 496-509.
4. Griffiths CE, Barker JN: Pathogenesis and clinical features of psoriasis. Lancet 2007; 370: 263-271. (Pubitemid 47069537)
5. Gelfand JM, Troxel AB, Lewis JD, Kurd SK, Shin DB, Wang X, Margolis DJ, Strom BL: The risk of mortality in patients with psoriasis: results of a population-based study. Arch Dermatol 2007; 143: 1493-1499. (Pubitemid 350277763)
6. Ginsburg IH, Link BG: Psychosocial consequences of rejection and stigma feelings in psoriasis patients. Int J Dermatol 1993; 32: 587-591. (Pubitemid 23274587)
7. Magin P, Adams J, Heading G, Pond D, Smith W: The psychological sequelae of psoriasis: results of a qualitative study. Psychol Health Med 2009; 14: 150-161.
8. Kragballe K, van de Kerkhof PC: Consistency of data in six phase III clinical studies of a two-compound product containing calcipotriol and betamethasone dipropionate ointment for the treatment of psoriasis. Br J Dermatol 2004; 150: 1167-1173.
9. Kragballe K, Noerrelund KL, Lui H, Ortonne JP, Wozel G, Uurasmaa T, Fleming C, Estebaranz JL, Hanssen LI, Persson LM: Efficacy of once-daily treatment regimens with calcipotriol/ betamethasone dipropionate ointment and calcipotriol ointment in psoriasis vulgaris. Br J Dermatol 2004; 150: 1167-1173. (Pubitemid 38932288)
10. Guenther L, van de Kerkhof PC, Snellman E, Kragballe K, Chu AC, Tegner E, Garcia-Diez A, Springborg J: Efficacy and safety of a new combination of calcipotriol and betamethasone dipropionate (one or twice daily) compared to dipropionate (twice daily) in the treatment of psoriasis vulgaris: a randomized, double-blind, vehicle-controlled clinical trial. Br J Dermatol 2002; 147: 316-323.
11. Kaufmann R, Bibby AJ, Bissonnette R, Cambazard F, Chu AC, Decroix J, Douglas WS, Lowson D, Mascaro JM, Murphy GM, Stymne B: A new calcipotriol/betamethasone dipropionate formulation (Daivobet) is an effective once-daily treatment for psoriasis vulgaris. Dermatology 2002; 205: 389-393. (Pubitemid 35356768)
12. Papp KA, Guenther L, Boyden B, Larsen FG, Harvima RJ, Guilhou JJ, Kaufmann R, Rogers S, van de Kerkhof PC, Hanssen LI, Tegner E, Burg G, Talbot D, Chu A: Early onset of action and efficacy of a combination of calcipotriene and betamethasone dipropionate in the treatment of psoriasis. J Am Acad Dermatol 2003; 48: 48-54. (Pubitemid 36091533)
13. Douglas WS, Poulin Y, Decroix J, Ortonne JP, Mrowietz U, Gulliver W, Krogstad AL, Larsen FG, Iglesias L, Buckley C, Bibby AJ: A new calcipotriol/betamethasone formulation with rapid onset of action was superior to monotherapy with betamethasone dipropionate in psoriasis vulgaris. Acta Derm Venereol 2002; 82: 131-135. (Pubitemid 34596689)
14. Van de Kerkhof PCM: Options for the treatment of psoriasis: a multifactor approach. Clin Dermatol 2008; 26: 419-423.
15. Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JYM, Lebwohl M, Lim HW, van Voorhees AS, Beutner KR, Bhushan R: Guidelines of care for the management of psoriasis and psoriatic arthritis. J Am Acad Dermatol 2009; 60: 643-659.
16. Saraceno R, Andreassi L, Ayala F, Bongiorno MR, Giannetti A, Lisi P, Martini P, Peris K, Peserico A, Chimenti S: Efficacy, safety and quality of life of calcipotriol/betamethasone dipropionate (Dovobet) versus calcipotriol (Daivonex) in the treatment of psoriasis vulgaris: a randomized, multicentre, clinical trial. J Dermatol Treat 2007; 18: 361-365. (Pubitemid 350223199)
17. Fenton C, Plosker GL: Calcipotriol/betamethasone dipropionate: a review of its use in the treatment of psoriasis vulgaris. Am J Clin Dermatol 2004; 5: 463-478. (Pubitemid 40178772)
18. Kragballe K, Austad J, Barnes L, Bibby A, de la Brassinne M, Cambazard F, Fleming C, Heikkila H, Jolliffe D, Peyri J, Svensson Å, Toole J, Wozel G: A 52-week randomized safety study of calcipotriol/betamethasone dipropionate two-compound product (Dovobet/ Daivobet/Taclonex) in the treatment of psoriasis vulgaris. Br J Dermatol 2006; 154: 1155-1160. (Pubitemid 43727399)
19. EMEA Guideline on Clinical Investigation of Medicinal Products Indicated for the Treatment of Psoriasis. 2004.
20. Katz HI, Prawer SE, Madansky RS, Krueger GG, Mooney JJ, Jones ML: Intermittent corticosteroid maintenance treatment of psoriasis: a double-blind multicentre trial of augmented betamethasone dipropionate ointment in a pulse dose treatment regimen. Dermatologica 1991; 183: 269-274.
21. Fleming C, Ganslandt C, Guenther L, Johannesson A, Buckley C, Simon JC, Stegmann H, Tingleff Lotte V: Calcipotriol plus betamethasone dipropionate gel compared with its active components in the same vehicle and the vehicle alone in the treatment of psoriasis vulgaris: a randomised, parallel group, double- blind, exploratory study. Eur J Dermatol 2010; 20: 465-471.
22. Richards HL, Fortune DG, Griffiths CEM: Adherence to treatment in patients with psoriasis. J Eur Acad Dermatol Venereol 2006; 20: 370-379.