The treatment of facial atopic dermatitis in children who are intolerant of, or dependent on, topical corticosteroids: a randomized, controlled clinical trial.
BACKGROUND
Atopic dermatitis (AD) is most prevalent in areas of reduced skin barrier reserve, like face and neck, especially in children. Treatment with topical corticosteroids (TCS) is limited due to heightened risk of treatment-associated side-effects, thus necessitating alternative AD therapies.


OBJECTIVE
The primary study objective was to determine the efficacy of pimecrolimus cream 1% in children with mild-moderate facial AD dependent on/intolerant of TCS. Secondary objectives included effects on overall Eczema Area and Severity Index (EASI), head/neck EASI, pruritus severity and time to clearance of facial AD.


METHODS
A multicentre, double-blind (DB) study of < or = 6 weeks, followed by a 6-week, open-label (OL) phase was conducted. Two hundred patients (aged 2-11 years) were randomized 1:1 to pimecrolimus cream 1% (n = 99) or vehicle (n = 101) twice daily until clearance of facial AD or for a maximum of 6 weeks (DB phase). Sixteen patients receiving vehicle were allowed to switch to the OL phase at day 22.


RESULTS
Significantly more pimecrolimus-treated vs. vehicle-treated patients were cleared/almost cleared of facial AD (Investigators' Global Assessment 0/1): 74.5% vs. 51.0%, P < 0.001 (day 43) [57.1% vs. 36.0%, P = 0.004 (day 22)]. Median time to clearance was 22.0 vs. 43.0 days (pimecrolimus vs. vehicle, respectively). Statistically significant differences for pimecrolimus vs. vehicle were also seen on head/neck EASI, overall EASI, and head/neck pruritus scores. Adverse events were mainly mild-moderate, occurring with similar frequency in both treatment groups.


CONCLUSIONS
In children with facial dermatitis intolerant of/dependent on TCS, pimecrolimus cream 1% effectively controls eczema and pruritus and is well tolerated.
Hoeger
P H
PH
Department of Paediatric Dermatology, Catholic Children's Hospital, Wilhelmstift, Liliencronstr. 130, 22149 Hamburg, Germany. p.hoeger@kkh-wilhelmstift.de
Lee
K-H
KH
Jautova
J
J
Wohlrab
J
J
Guettner
A
A
Mizutani
G
G
Hultsch
T
T
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000139:chemically induced / Q000188:drug therapy* / Q000473:pathology; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004485:Eczema / Q000139:chemically induced / Q000188:drug therapy* / Q000473:pathology; D005148:Facial Dermatoses / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D014677:Pharmaceutical Vehicles; D011537:Pruritus / Q000139:chemically induced / Q000188:drug therapy / Q000473:pathology; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D003879:Dermatologic Agents; D014677:Pharmaceutical Vehicles; C117268:pimecrolimus; D016559:Tacrolimus