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

被引:63
|
作者
Fleming, Colin [2 ]
Ganslandt, Cecilia [1 ]
Guenther, Lyn [3 ]
Johannesson, Anders [4 ]
Buckley, Colin [5 ]
Simon, Jan C. [6 ]
Stegmann, Helen [1 ]
Tingleff, Lotte Vestergaard [1 ]
机构
[1] LEO Pharma AS, DK-2750 Ballerup, Denmark
[2] Univ Dundee, Ninewells Hosp & Med Sch, Dundee DD1 9SY, Scotland
[3] Guenther Dermatol Res Ctr, London, ON, Canada
[4] Vallingby Lakarhus, Vallingby, Sweden
[5] Waterford Reg Hosp, Waterford, Ireland
[6] Univ Klinikum Leipzig, Klin Dermatol Venerol & Allergol, Leipzig, Germany
关键词
betamethasone dipropionate; calcipotriol; combination therapy; psoriasis vulgaris; ONCE-DAILY TREATMENT; SCALP PSORIASIS; FORMULATION; EFFICACY; SAFETY; COMBINATION; POPULATION; TRIAL; ONSET;
D O I
10.1684/ejd.2010.0948
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
A two-compound ointment containing calcipotriol plus betamethasone dipropionate is an effective treatment for psoriasis vulgaris. The same active ingredients have now been combined in a gel formulation. Our objective was to compare the efficacy and safety of once daily treatment of the two-compound gel with the single components in the same gel vehicle and the gel vehicle alone, in patients with psoriasis vulgaris on the trunk and/or limbs. 364 patients received once daily treatment for up to 8 weeks with either the two-compound gel, the single components in the gel vehicle or the gel vehicle alone. The percentage of patients whose disease was clear or very mild and who had at least a two-step improvement in the Investigator's Global Assessment of disease severity at week 8, was significantly higher with calcipotriol plus betamethasone dipropionate (27.2%) than with betamethasone dipropionate (16.9%, p = 0.027), calcipotriol (11.4%, p = 0.006) or gel vehicle (0.0%, p < 0.001). This exploratory study showed that the two-compound gel was safe and more efficacious than its individual ingredients in the treatment of psoriasis vulgaris.
引用
收藏
页码:465 / 471
页数:7
相关论文
共 50 条
  • [21] Efficacy and Safety of Clindamycin-Tretinoin Gel Versus Clindamycin or Tretinoin Alone in Acne Vulgaris: A Randomized, Double-Blind, Vehicle-Controlled Study
    Jarratt, Michael T.
    Brundage, Torn
    JOURNAL OF DRUGS IN DERMATOLOGY, 2012, 11 (03) : 318 - 326
  • [22] A double-blind randomized, vehicle-controlled, multicenter study to assess tretinoin gel microsphere 0.04% in the treatment of acne vulgaris in adults
    Fleischer, A
    Leyden, J
    Lucky, A
    Nighland, M
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2006, 54 (03) : AB23 - AB23
  • [23] Oral Prolonged Release Beclomethasone Dipropionate and Prednisone in the Treatment of Active Ulcerative Colitis: Results From a Double-Blind, Randomized, Parallel Group Study
    Van Assche, Gert
    Manguso, Francesco
    Zibellini, Marco
    Cabriada Nuno, Jose Luis
    Goldis, Adrian
    Tkachenko, Evgeniy
    Varoli, Guido
    Kleczkowski, Dariusz
    Annese, Vito
    D'Heygere, Francois
    Balzano, Antonio
    AMERICAN JOURNAL OF GASTROENTEROLOGY, 2015, 110 (05): : 708 - 715
  • [24] Combination treatment with methotrexate, cyclosporine, and intraarticular betamethasone compared with methotrexate and intraarticular betamethasone in early active rheumatoid arthritis - An investigator-initiated, multicenter, randomized, double-blind, parallel-group, placebo-controlled study
    Hetland, Merete Lund
    Stengaard-Pedersen, Kristian
    Junker, Peter
    Lottenburger, Tine
    Ellingsen, Torkell
    Andersen, Lis Smedegaard
    Hansen, Lb
    Skjodt, Henrik
    Pedersen, Jens Kristian
    Lauridsen, Ulrik Birk
    Svendsen, Anders
    Tarp, Ulrik
    Podenphant, Jan
    Hansen, Gert
    Lindegaard, Hanne
    De Carvalho, Anselmo
    Ostergaard, Mikkel
    Horslev-Petersen, Kim
    ARTHRITIS AND RHEUMATISM, 2006, 54 (05): : 1401 - 1409
  • [25] A novel aerosol foam formulation of calcipotriene (Cal) 0.005% plus betamethasone dipropionate (BD) 0.064% is more efficacious than Cal and BD foam alone in treating psoriasis vulgaris: A randomized, double-blind, multicenter, three-arm, phase II study
    Lebwohl, Mark
    Tyring, Stephen
    Bukhalo, Michael
    Alonso-Llamazares, Javier
    Olesen, Martin
    Lowson, David
    Yamauchi, Paul
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2015, 72 (05) : AB222 - AB222
  • [26] A double-blind, randomized, vehicle-controlled, parallel group, multicenter study to assess the efficacy and safety of a topical gel product containing ketoconazole USP 2% in the treatment of seborrheic dermatitis
    Beger, B
    Highton, A
    Barranco, C
    Legendre, R
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2005, 52 (03) : P122 - P122
  • [27] Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Foam Formulation of Halobetasol Propionate, 0.05% vs Its Vehicle in Adult Subjects With Plaque Psoriasis
    Bhatia, Neal
    Gold, Linda Stein
    Kircik, Leon H.
    Schreiber, Rhonda
    JOURNAL OF DRUGS IN DERMATOLOGY, 2019, 18 (08) : 790 - 796
  • [28] Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Enhanced Lotion Formulation of Halobetasol Propionate, 0.05% Versus Its Vehicle in Adult Subjects With Plaque Psoriasis
    Pariser, David
    Bukhalo, Michael
    Guenthner, Scott
    Kempers, Steven
    Shideler, Stephen
    Gold, Linda Stein
    Tschen, Eduardo
    Berg, Jim
    Ferdon, Mary Beth
    Dromgoole, Syd
    JOURNAL OF DRUGS IN DERMATOLOGY, 2017, 16 (03) : 234 - 240
  • [29] Effects of tazarotene 0.1% cream in the treatment of facial acne vulgaris: Pooled results from two multicenter, double-blind, randomized, vehicle-controlled, parallel-group trials
    Shalita, AR
    Berson, DS
    Thiboutot, DM
    Leyden, JJ
    Parizadeh, D
    Sefton, J
    Walker, PS
    Gibson, JR
    CLINICAL THERAPEUTICS, 2004, 26 (11) : 1865 - 1873
  • [30] A multicentre, randomised, parallel-group, double-blind, vehicle-controlled and open-label, active-controlled study (versus amorolfine 5%), to evaluate the efficacy and safety of terbinafine 10% nail lacquer in the treatment of onychomycosis
    Blume-Peytavi, Ulrike
    Tosti, Antonella
    Falques, Meritxell
    Luisa Tamarit, Maria
    Carreno, Cristina
    Galvan, Jordi
    Tebbs, Veronica
    MYCOSES, 2022, 65 (04) : 392 - 401