A randomized, double-blind, vehicle-controlled study of 1% pimecrolimus cream in adult patients with perioral dermatitis.
BACKGROUND
Perioral dermatitis (POD) is a common dermatosis without standard therapy.


OBJECTIVE
We sought to evaluate pimecrolimus cream 1% in POD.


METHODS
We conducted a multicenter, randomized, double-blind, parallel-group study in adult patients with POD treated twice daily with pimecrolimus cream 1% or vehicle until clearance for up to 4 weeks. Follow-up took place 4 and 8 weeks after treatment.


RESULTS
Patients treated with pimecrolimus had an average POD Severity Index score of 2.6 compared with 3.5 for patients treated with vehicle. Both groups had baseline scores of 5.2. The between-group difference was 0.9 (95% confidence level 0.4, 1.4, P = .0011). Patients with history of topical corticosteroids benefited most. Pimecrolimus-treated patients reported greater improvement in quality of life. There were no group differences regarding safety.


CONCLUSIONS
Pimecrolimus vehicle is not a true placebo.


CONCLUSIONS
Pimecrolimus rapidly improves clinical symptoms and quality of life of patients with POD, being most effective in corticosteroid-induced POD.
Schwarz
Thomas
T
Department of Dermatology, University of Kiel, Kiel, Germany. tschwarz@dermatology.uni-kiel.de
Kreiselmaier
Inga
I
Bieber
Thomas
T
Thaci
Diamant
D
Simon
Jan C
JC
Meurer
Michael
M
Werfel
Thomas
T
Zuberbier
Torsten
T
Luger
Thomas A
TA
Wollenberg
Andreas
A
Bräutigam
Matthias
M
D000279:Administration, Cutaneous; D000305:Adrenal Cortex Hormones / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D019557:Dermatitis, Perioral / Q000139:chemically induced / Q000188:drug therapy*; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D014677:Pharmaceutical Vehicles; D011788:Quality of Life; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D000894:Anti-Inflammatory Agents, Non-Steroidal; D003879:Dermatologic Agents; D009824:Ointments; D014677:Pharmaceutical Vehicles; C117268:pimecrolimus; D016559:Tacrolimus