First experience of topical SDZ ASM 981 in children with atopic dermatitis.
BACKGROUND
SDZ ASM 981 is a selective inhibitor of inflammatory cytokine release under development for the topical treatment of atopic dermatitis.


OBJECTIVE
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).
Harper
J
J
Department of Paediatric Dermatology, Great Ormond Street Hospital for Children, London WC1 3JH, UK.
Green
A
A
Scott
G
G
Gruendl
E
E
Dorobek
B
B
Cardno
M
M
Burtin
P
P
D000279:Administration, Cutaneous; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D003879:Dermatologic Agents / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood / Q000627:therapeutic use*; D016896:Treatment Outcome
D003879:Dermatologic Agents; C117268:pimecrolimus; D016559:Tacrolimus