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Improvement in pruritus in children with atopic dermatitis using pimecrolimus cream 1%.
- Source :
-
Cutis [Cutis] 2007 Jan; Vol. 79 (1), pp. 65-72. - Publication Year :
- 2007
-
Abstract
- 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).
- Subjects :
- Adolescent
Case-Control Studies
Child
Child, Preschool
Dermatologic Agents administration & dosage
Double-Blind Method
Drug Administration Schedule
Emollients
Follow-Up Studies
Humans
Immunosuppressive Agents administration & dosage
Pharmaceutical Vehicles
Placebos
Severity of Illness Index
Tacrolimus administration & dosage
Tacrolimus therapeutic use
Time Factors
Treatment Outcome
Calcineurin Inhibitors
Dermatitis, Atopic drug therapy
Dermatologic Agents therapeutic use
Immunosuppressive Agents therapeutic use
Peptidylprolyl Isomerase antagonists & inhibitors
Pruritus drug therapy
Tacrolimus analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 0011-4162
- Volume :
- 79
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Cutis
- Publication Type :
- Academic Journal
- Accession number :
- 17330625