Pimecrolimus cream 1% in the treatment of intertriginous psoriasis: a double-blind, randomized study.

Author(s): Gribetz C, Ling M, Lebwohl M, Pariser D, Draelos Z, Gottlieb AB, Zaias N, Chen DM, Parneix-Spake A, Hultsch T, Menter A

Affiliation(s): Mt Sinai School of Medicine, Department of Dermatology, New York, New York, USA.

Publication date & source: 2004-11, J Am Acad Dermatol., 51(5):731-8.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

BACKGROUND: Inverse psoriasis can be difficult to treat because of the high sensitivity of intertriginous areas to cutaneous side effects, such as irritation and striae. Pimecrolimus, a well-tolerated, nonatrophogenic, skin-selective inflammatory cytokine inhibitor, has been shown to be effective in the treatment of psoriasis when applied topically under occlusion. OBJECTIVE: This study evaluated the efficacy and safety of pimecrolimus cream 1% versus vehicle twice a day in the treatment of inverse psoriasis. Methods This was a double-blind, randomized, vehicle-controlled study in 57 patients with moderate to severe inverse psoriasis. Patients were evaluated using Investigator's Global Assessment of overall severity, Target Area Score, and Patient Self-Assessment. RESULTS: A significant between-group difference was observed early on, with 54% of the pimecrolimus group versus 21% of the vehicle group having an Investigator's Global Assessment score of 0 or 1 (clear or almost clear) at week 2 ( P = .0169). By week 8, 71% of the pimecrolimus group had an Investigator's Global Assessment score of 0 or 1. Change from baseline in Target Area Score was -2.4 (pimecrolimus group) compared with -0.7 (vehicle) at day 3 ( P < .0001). By week 8, 82% of patients using pimecrolimus scored their disease as well or completely controlled versus 41% of the vehicle group ( P = .0007). Adverse events were similar between groups. CONCLUSION: Pimecrolimus cream 1% is an effective treatment for inverse psoriasis with a rapid onset of action, and is safe and well-tolerated.