title: Twice weekly fluticasone propionate added to emollient maintenance treatment to reduce risk of relapse in atopic dermatitis: randomised, double blind, parallel group study.
abstract: 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.
authors.affiliation: Department of Dermatology, University Hospitals Coventry and Warwickshire NHS Trust, Walsgrave Hospital, Coventry CV2 2DX. johnberthjones@a ol.com
authors.forename: John
authors.initials: J
authors.lastname: Berth-Jones
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Damstra
authors.forename: Stefan
authors.initials: S
authors.lastname: Golsch
authors.forename: John K
authors.initials: JK
authors.lastname: Livden
authors.forename: Oliver
authors.initials: O
authors.lastname: Van Hooteghem
authors.forename: Fulvio
authors.initials: F
authors.lastname: Allegra
authors.forename: Christine A
authors.initials: CA
authors.lastname: Parker
mesh_terms: 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
chemical_list: D000730:Androstadienes; D003879:Dermatologic Agents; D004643:Emollients; D000068298:Fluticasone