Study for Treatment With Calcipotriol/Betamethasone Dipropionate Gel in Korean Patients With Psoriasis Vulgaris

Summary

The combination of calcipotriol and betamethasone dipropionate used in an ointment formulation (Daivobet® ointment) has shown to have an excellent efficacy and safety in the short-term and long-term management of psoriasis vulgaris. A newly developed gel formulation (Xamiol® gel) of calcipotriol and betamethasone dipropionate has recently been approved and marketed in Korea as a topical treatment of moderate to severe scalp psoriasis and non-scalp psoriasis vulgaris. Xamiol® gel, the investigational product (IP) used in this study, prevents keratinization by normalizing the reproduction cycle of skin cells. It also relieves itching associated with psoriasis. Xamiol® gel was initially approved for treatment of moderate to severe scalp psoriasis and its label was extended to non-scalp psoriasis vulgaris in October 2012. Since patient compliance is one of the important factors in achieving effective outcomes in the treatment of psoriasis, the once daily dosing of Xamiol® gel is expected to enhance compliance and treatment outcomes as well as to provide a safe and effective therapeutic option.

Timeline

Start

2013-10

Primary completion

2014-06

Completion

2014-06

Publications

• Results Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 2007 Feb 22;445(7130):866-73. doi: 10.1038/nature05663.
• Results Lew W, Lee E, Krueger JG. Psoriasis genomics: analysis of proinflammatory (type 1) gene expression in large plaque (Western) and small plaque (Asian) psoriasis vulgaris. Br J Dermatol. 2004 Apr;150(4):668-76. doi: 10.1111/j.0007-0963.2004.05891.x.
• Results Pariser DM, Bagel J, Gelfand JM, Korman NJ, Ritchlin CT, Strober BE, Van Voorhees AS, Young M, Rittenberg S, Lebwohl MG, Horn EJ; National Psoriasis Foundation. National Psoriasis Foundation clinical consensus on disease severity. Arch Dermatol. 2007 Feb;143(2):239-42. doi: 10.1001/archderm.143.2.239.
• Results Kragballe K, Austad J, Barnes L, Bibby A, de la Brassinne M, Cambazard F, Fleming C, Heikkila H, Williams Z, Peyri Rey J, Svensson A, Toole J, Wozel G. Efficacy results of a 52-week, randomised, double-blind, safety study of a calcipotriol/betamethasone dipropionate two-compound product (Daivobet/Dovobet/Taclonex) in the treatment of psoriasis vulgaris. Dermatology. 2006;213(4):319-26. doi: 10.1159/000096069.
• Results 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 Jun;150(6):1167-73. doi: 10.1111/j.1365-2133.2004.05986.x.
• Results Langley RG, Gupta A, Papp K, Wexler D, Osterdal ML, Curcic D. 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. 2011;222(2):148-56. doi: 10.1159/000323408. Epub 2011 Feb 3.
• Results Samarasekera E, Sawyer L, Parnham J, Smith CH; Guideline Development Group. Assessment and management of psoriasis: summary of NICE guidance. BMJ. 2012 Oct 24;345:e6712. doi: 10.1136/bmj.e6712. No abstract available.

Drugs

Indications