Improvement in pruritus in children with atopic dermatitis using pimecrolimus cream 1%.

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).

• Authors: Joseph Fowler, Anthony Johnson, Michael Chen, Ken Abrams
• Journal: Cutis (Cutis) Vol. 79 Issue 1 Pg. 65-72 (Jan 2007) ISSN: 0011-4162 [Print] United States
• PMID: 17330625 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Calcineurin Inhibitors
• Dermatologic Agents
• Emollients
• Immunosuppressive Agents
• Pharmaceutical Vehicles
• Placebos
• pimecrolimus
• Peptidylprolyl Isomerase
• Tacrolimus

Topics

• Adolescent
• Calcineurin Inhibitors
• Case-Control Studies
• Child
• Child, Preschool
• Dermatitis, Atopic (drug therapy)
• Dermatologic Agents (administration & dosage, therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Emollients
• Follow-Up Studies
• Humans
• Immunosuppressive Agents (administration & dosage, therapeutic use)
• Peptidylprolyl Isomerase (antagonists & inhibitors)
• Pharmaceutical Vehicles
• Placebos
• Pruritus (drug therapy)
• Severity of Illness Index
• Tacrolimus (administration & dosage, analogs & derivatives, therapeutic use)
• Time Factors
• Treatment Outcome