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


CONCLUSIONS
Pimecrolimus cream 1% is an effective treatment for inverse psoriasis with a rapid onset of action, and is safe and well-tolerated.
Gribetz
Carin
C
Mt Sinai School of Medicine, Department of Dermatology, New York, New York, USA.
Ling
Mark
M
Lebwohl
Mark
M
Pariser
David
D
Draelos
Zoe
Z
Gottlieb
Alice B
AB
Zaias
Nardo
N
Chen
Diana M
DM
Parneix-Spake
Anne
A
Hultsch
Thomas
T
Menter
Alan
A
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D011565:Psoriasis / Q000188:drug therapy*; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003879:Dermatologic Agents; D009824:Ointments; C117268:pimecrolimus; D016559:Tacrolimus