Percutaneous absorption of pimecrolimus is not increased in patients with moderate to severe atopic dermatitis when pimecrolimus cream 1% is applied under occlusion

Dermatology. 2010;221(4):342-51. doi: 10.1159/000320125. Epub 2010 Nov 22.

Abstract

Aim: To evaluate the systemic exposure of pimecrolimus cream 1% applied under occlusion in atopic dermatitis (AD) patients.

Methods: A noncomparative, open-label study conducted in 3 groups of moderate to severe AD patients: A (adults, n = 9), B (adolescents, n = 4) and C (children, n = 6). Pimecrolimus cream 1% was applied twice daily for 8.5 days with overnight occlusion in patients with investigator's global assessment scores of ≥3 and AD involving at least 30% of their body surface area. Pimecrolimus blood concentrations were analyzed.

Results: The highest pimecrolimus blood concentrations observed in adults, adolescents and children were 1.84, 0.55 and 1.29 ng/ml, respectively. Pimecrolimus blood concentrations and affected body surface area showed no apparent correlation.

Conclusion: No measurable differences were found in pimecrolimus blood concentrations, efficacy and safety profile when pimecrolimus cream 1% was applied under occlusion versus application without occlusion. These findings reflect the high lipophilic properties of pimecrolimus.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Child
  • Child, Preschool
  • Dermatitis, Atopic / drug therapy*
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / blood
  • Immunosuppressive Agents / pharmacokinetics*
  • Male
  • Severity of Illness Index
  • Skin Absorption*
  • Tacrolimus / administration & dosage
  • Tacrolimus / analogs & derivatives*
  • Tacrolimus / blood
  • Tacrolimus / pharmacokinetics
  • Treatment Outcome
  • Young Adult

Substances

  • Immunosuppressive Agents
  • pimecrolimus
  • Tacrolimus