Tacrolimus ointment is effective for facial and intertriginous psoriasis - 24/08/11
for the Tacrolimus Ointment Study Group New York, New York; Lebanon, New Hampshire; Winston-Salem, North Carolina; Deerfield, Illinois; and Rockville, Maryland
Abstract |
Background |
Intertriginous and facial involvement are manifestations of psoriasis that require a different approach than is used for typical plaque psoriasis on other skin areas. Topical corticosteroids are the primary treatment for psoriasis; however, the side effects of corticosteroids are magnified on intertriginous and facial skin. Topical tacrolimus offers the potential for anti-inflammatory effect without the atrophy or other local side effects associated with the use of topical corticosteroids.
Objective |
To determine the efficacy and tolerability of 0.1% tacrolimus ointment for the treatment of facial or intertriginous psoriasis.
Methods |
One hundred sixty-seven patients 16 years or older were evaluated in an 8-week, randomized, double-blind, vehicle-controlled, multi-center study. Upon entry into the study, patients were randomized 2:1 to apply the tacrolimus ointment 0.1% or vehicle twice daily to all psoriatic lesions of the face or intertriginous areas for 8 weeks. The physician's global assessment was used to assess improvement from baseline. The inverse psoriasis severity for patients was measured using a 6-point scale from clear to very severe.
Results |
As early as day 8, more patients (P=.004) had cleared or achieved excellent improvement in the 0.1% tacrolimus ointment group compared to the vehicle group (24.8% vs 5.8%). At the end of the 8-week treatment period 65.2% of the tacrolimus ointment group and 31.5% of the vehicle were clear or almost clear (P < .0001) based on a Static Severity Score. Adverse events were similar in the 0.1% tacrolimus ointment and vehicle groups.
Conclusion |
Tacrolimus ointment is an effective treatment for psoriasis of the face or intertriginous areas.
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Funded by Fujisawa Healthcare, Inc. Jennifer Hartle is an employee of Fujisawa Healthcare, Inc. Roles and additional members of the Tacrolimus Ointment Study Group: Lead Investigator, protocol development, author: Mark Lebwohl, Mt. Sinai School of Medicine; Authors: Shane Chapman, Dartmouth University; Steven Feldman, Wake Forest University; Amy Krupnick Freeman, Mt. Sinai School of Medicine; Investigators: Ivor Caro, Harvard University; Boni Elewski, University of Alabama; Harold Farber, Hahneman University; Kenneth Gordon, Northwestern University; H. Irving Katz, University of Minnesota; Neil Korman, Case Western Reserve University; David Pariser, Virginia Clinical Research; Alice Pentland, University of Rochester; Jerome Shupack, New York University; Michael Tharpe, Rush-Presbyterian St. Luke's; Gerald Weinstein, University California–Irvine; Protocol development, project management, author: Jennifer E. Hartle, Fujisawa Healthcare, Inc.; Protocol development, statistician, author: Alice Henning, The EMMES Corporation. |
Vol 51 - N° 5
P. 723-730 - novembre 2004 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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