First Experience of Topical SDZ ASM 981 in Children With Atopic Dermatitis

Br J Dermatol. 2001 Apr;144(4):781-7. doi: 10.1046/j.1365-2133.2001.04133.x.

Abstract

Background: SDZ ASM 981 is a selective inhibitor of inflammatory cytokine release under development for the topical treatment of atopic dermatitis.

Objectives: This first paediatric study was designed to measure the systemic exposure to SDZ ASM 981 in young children with atopic dermatitis treated on extensive skin areas.

Methods: Children 1-4 years of age referred to a tertiary care centre for their atopic dermatitis were treated twice daily for 3 weeks with 1% SDZ ASM 981 cream. SDZ ASM 981 blood concentrations were measured on day 4 and 22 (last day) of treatment, and 1 week after the last application, using a radioimmunoassay with a limit of quantification of 0.5 ng mL(-1). Efficacy was assessed by the Eczema Area Severity Index (EASI).

Results: The 10 patients included had 23-69% of their body surface area (BSA) affected at baseline. Of the 63 SDZ ASM 981 blood concentrations measured, 63% were < 0.5 ng mL(-1); the maximum value observed was 1.8 ng mL-1. No accumulation was evidenced between days 4 and 22. The first two patients experienced a flare of atopic dermatitis that was not controlled by the study medication. In the other patients, the EASI improved by 8-89% at 3 weeks of treatment.

Conclusions: In these children 1-4 years of age, blood concentrations of SDZ ASM 981 during topical treatment with the 1% cream were consistently low even in the children with the most extensive areas treated (up to 69% of their BSA).

Publication types

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

MeSH terms

  • Administration, Cutaneous
  • Child, Preschool
  • Dermatitis, Atopic / blood
  • Dermatitis, Atopic / drug therapy*
  • Dermatitis, Atopic / pathology
  • Dermatologic Agents / adverse effects
  • Dermatologic Agents / blood
  • Dermatologic Agents / therapeutic use*
  • Drug Administration Schedule
  • Female
  • Humans
  • Infant
  • Male
  • Severity of Illness Index
  • Tacrolimus / adverse effects
  • Tacrolimus / analogs & derivatives*
  • Tacrolimus / blood
  • Tacrolimus / therapeutic use*
  • Treatment Outcome

Substances

  • Dermatologic Agents
  • pimecrolimus
  • Tacrolimus