Improvement in pruritus in children with atopic dermatitis using pimecrolimus cream 1%.
The objective of this study was to assess time to onset of pruritus improvement in a pediatric population treated with pimecrolimus cream 1%. This 8-day, double-blinded, vehicle-controlled study randomized 174 children and adolescents (aged 2-17 years) with mild to moderate atopic dermatitis (AD) and moderate to severe pruritus to twice-daily applications of pimecrolimus cream 1% or vehicle. There were no significant between-group differences in demographics or baseline disease characteristics. Pruritus was assessed by subjects using a 4-point pruritus severity scale (0-3). The primary efficacy variable was time to a 1 point or more improvement in pruritus score from baseline. The 2 treatment groups were compared using log-rank testing of the time-to-event data. In the per-protocol (PP) population, median times to a 1 point or more improvement in pruritus score were 48 and 72 hours for pimecrolimus and vehicle groups, respectively (P = .038). From day 3 onward, significantly more subjects (P = .023) in the pimecrolimus group versus the vehicle group reported complete pruritus resolution. Pimecrolimus cream 1% improved pruritus within 48 hours in children and adolescents with mild to moderate AD and achieved complete resolution of pruritus in a significantly greater number of subjects in the pimecrolimus group versus the vehicle group by the end of the 7-day treatment period (P = .008).
Fowler
Joseph
J
Department of Dermatology, University of Louisville, Kentucky, USA. fowlerjoe@msn.com
Johnson
Anthony
A
Chen
Michael
M
Abrams
Ken
K
D000293:Adolescent; D065095:Calcineurin Inhibitors; D016022:Case-Control Studies; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004643:Emollients; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019696:Peptidylprolyl Isomerase / Q000037:antagonists & inhibitors*; D014677:Pharmaceutical Vehicles; D010919:Placebos; D011537:Pruritus / Q000188:drug therapy*; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome
D065095:Calcineurin Inhibitors; D003879:Dermatologic Agents; D004643:Emollients; D007166:Immunosuppressive Agents; D014677:Pharmaceutical Vehicles; D010919:Placebos; C117268:pimecrolimus; D019696:Peptidylprolyl Isomerase; D016559:Tacrolimus