Twice weekly fluticasone propionate added to emollient maintenance treatment to reduce risk of relapse in atopic dermatitis: randomised, double blind, parallel group studyBMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7403.1367 (Published 19 June 2003) Cite this as: BMJ 2003;326:1367
- John Berth-Jones, consultant dermatologist (, )
- Robert J Damstra, dermatologist,
- Stefan Golsch, dermatologist,
- John K Livden, associate professor,
- Oliver Van Hooteghem, head of department of dermatology,
- Fulvio Allegra, director,
- Christine A Parker, director a multinational study group
- Department of Dermatology, University Hospitals Coventry and Warwickshire NHS Trust, Walsgrave Hospital, Coventry CV2 2DX
- Ziekenhuis Nij Smellinghe, Compagnonsplein 1, 9202 NN Drachten, Netherlands
- Praxis Dr Golsch, Bayerstrasse 45, D-80335 Munich, Germany
- Hudpoliklinikken, Teatergaten 37, N-5010 Bergen, Norway
- Clinique Ste Elisabeth, Place Louise Godin 15, B-5000 Namur, Belgium
- Institute of Medical and Surgical Dermatology, University of Parma, I-43100 Parma, Italy
- clinical development and medical affairs GlaxoSmithKline, Research and Development, Greenford, Middlesex UB6 0HE
- J Berth-Jones
- Accepted 13 May 2003
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.
Design Randomised, double blind, parallel group study of 20 weeks' duration.
Setting Dermatology outpatient clinics (6 countries, 39 centres).
Participants 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.
Main outcome measure 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.
Conclusion After atopic dermatitis had been stabilised the addition of fluticasone propionate twice weekly to maintenance treatment with emollients significantly reduced the risk of relapse.
Contributors JBJ and CP were involved in the design of the study, as were Robin Graham Brown (Leicester Royal Infirmary, UK) and Jan B van der Meer (Academic Hospital, Groningen, Netherlands). Eltjo J Glazenburg (GSK), Michael Herdman (GSK consultant) and Julie Duncan (GSK) were also involved in the design of the study and contributed to discussion of results. All named authors commented on the study design, took part in the study and contributed to the interpretation of analysed data during the preparation, review and approval of the final manuscript. Martin J Rimmer (GSK) provided statistical advice during the writing of the paper and Susan Daly (GSK consultant) managed the publication process through to the final manuscript. JBJ is the guarantor.
Funding Glaxo Wellcome (now GlaxoSmithKline) R & D, United Kingdom.
Competing interests CP is employed full time by GlaxoSmith-Kline.
Ethical approval The study was approved by appropriate local research ethics committees.
- Accepted 13 May 2003