Twice weekly fluticasone propionate added to emollient maintenance treatment to reduce risk of relapse in atopic dermatitis: randomised, double blind, parallel group study.
OBJECTIVE
To explore the efficacy and safety of fluticasone propionate, cream and ointment, applied twice weekly in addition to maintenance treatment with emollients, in reducing the risk of relapse of chronic recurrent atopic dermatitis.


METHODS
Randomised, double blind, parallel group study of 20 weeks' duration.


METHODS
Dermatology outpatient clinics (6 countries, 39 centres).


METHODS
Adult (aged 12-65) patients with moderate to severe atopic dermatitis who were experiencing a flare.


METHODS
Participants applied fluticasone propionate (0.05% cream or 0.005% ointment; once or twice daily) regularly for four weeks to stabilise their condition. The patients whose disease was brought under control then continued into a 16 week maintenance phase, applying emollient on a daily basis with a bath oil as needed and either the same formulation of fluticasone propionate or its placebo base (emollient alone) twice weekly to the areas that were usually affected.


METHODS
Time to relapse of atopic dermatitis during maintenance phase.


RESULTS
376 patients entered the stabilisation phase, and 295 continued into the maintenance phase. After 16 weeks in the maintenance phase, the disease remained under control in 133 patients (87 using fluticasone propionate twice weekly, 46 using emollient alone), 135 (40 fluticasone propionate, 95 emollient) had experienced a relapse, and 27 had discontinued. Median time to relapse was six weeks for emollient alone compared with more than 16 weeks for additional fluticasone propionate. Patients who applied fluticasone propionate cream twice weekly were 5.8 times less likely (95% confidence interval 3.1 to 10.8, P < 0.001) and patients using fluticasone propionate ointment 1.9 times less likely (1.2 to 3.2, P=0.010) to have a relapse than patients applying emollient alone. The groups showed no differences in adverse events.


CONCLUSIONS
After atopic dermatitis had been stabilised the addition of fluticasone propionate twice weekly to maintenance treatment with emollients significantly reduced the risk of relapse.
Berth-Jones
John
J
Department of Dermatology, University Hospitals Coventry and Warwickshire NHS Trust, Walsgrave Hospital, Coventry CV2 2DX. johnberthjones@a ol.com
Damstra
Robert J
RJ
Golsch
Stefan
S
Livden
John K
JK
Van Hooteghem
Oliver
O
Allegra
Fulvio
F
Parker
Christine A
CA
D000293:Adolescent; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D003876:Dermatitis, Atopic / Q000517:prevention & control*; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004643:Emollients / Q000008:administration & dosage / Q000009:adverse effects; D000068298:Fluticasone; D006801:Humans; D008875:Middle Aged; D012307:Risk Factors; D055502:Secondary Prevention; D016896:Treatment Outcome
D000730:Androstadienes; D003879:Dermatologic Agents; D004643:Emollients; D000068298:Fluticasone