First experience of topical SDZ ASM 981 in children with atopic dermatitis
Version of Record online: 22 AUG 2002
British Journal of Dermatology
Volume 144, Issue 4, pages 781–787, April 2001
How to Cite
Harper, J. , Green, A. , Scott, G. , Gruendl, E. , Dorobek, B. , Cardno, M. and Burtin, P. (2001), First experience of topical SDZ ASM 981 in children with atopic dermatitis. British Journal of Dermatology, 144: 781–787. doi: 10.1046/j.1365-2133.2001.04133.x
- Issue online: 22 AUG 2002
- Version of Record online: 22 AUG 2002
- Accepted for publication 21 December 2000
- atopic dermatitis;
- SDZ ASM 981;
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).