Acute and maintenance treatment of atopic dermatitis in children - two comparative studies with fluticasone propionate (0.05%) cream.
BACKGROUND
Two multicentre, randomised, parallel group, double-blind, comparative studies in children (2-14 yr) evaluated fluticasone propionate (FP) 0.05% cream for both acute and maintenance treatment of moderate to severe atopic dermatitis (AD).


METHODS
One study compared FP with hydrocortisone (HC) 1% cream (FP 70, HC 67) and the other with hydrocortisone butyrate (HCB) 0.1% cream (FP 67, HCB 62). Treatments were applied twice daily, for 2-4 weeks until the AD was stabilised, and thereafter intermittently ('as required') for up to 12 weeks.


RESULTS
The primary outcome measure, Total AD Score, recorded at the end of the acute and maintenance phases, was significantly lower (indicating improvements in disease severity) following treatment with FP compared with either HC or HCB (acute phase difference vs. HC, -2.39, 95%CI -3.47, -1.31; p<0.001 and vs. HCB, -1.25, 95%CI -2.46, -0.05; p=0.042) and (maintenance phase difference vs. HC, -1.88, 95%CI -3.20, -0.56; p=0.006 and vs. HCB, -1.39, 95%CI -2.72, -0.05; p=0.042). In both studies treatments were equally well tolerated with no visible signs of skin atrophy.


CONCLUSIONS
In both the acute and longer term management of AD in children, FP demonstrated a high level of efficacy and maintenance of disease control with a tolerability similar to HC 1%, a lower potency corticosteroid.
Kirkup
M E
ME
Bristol Royal Infirmary and Bristol Royal Hospital for Sick Children, Bristol, UK. Maggie.Kirkup@ubht.swest.nhs.uk
Birchall
N M
NM
Weinberg
E G
EG
Helm
K
K
Kennedy
C T C
CT
D000208:Acute Disease; D000287:Administration, Topical; D000293:Adolescent; D000730:Androstadienes / Q000008:administration & dosage / Q000627:therapeutic use*; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D009824:Ointments; D016896:Treatment Outcome
D000730:Androstadienes; D018926:Anti-Allergic Agents; D000893:Anti-Inflammatory Agents; D009824:Ointments; D000068298:Fluticasone; D006854:Hydrocortisone