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A randomised, controlled trial to compare prednisolone with doxycycline.

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Presentation on theme: "A randomised, controlled trial to compare prednisolone with doxycycline."— Presentation transcript:

1 A randomised, controlled trial to compare prednisolone with doxycycline

2 Bullous pemphigoid Most common autoimmune blistering disease in Western Europe Incidence: estimates vary - audit of the Oxfordshire region (2001-4) showed incidence of 33.4 cases/million/year Oral prednisolone most common treatment in UK (UK DCTN survey) and Germany (30 hospitals) This is an effective drug but has many side effects, especially severe in this elderly population

3 Why do this study? Rationale for the study: Clinical equipoise between steroids and tetracyclines for the treatment of bullous pemphigoid. Question identified by Cochrane systematic review and UK DCTN Research question: Is doxycycline sufficiently effective and safe to be used as a first line treatment for bullous pemphigoid? Primary objectives: Safety: Measured by the number of significant blisters present at week 6 Effectiveness: Measured by the number of severe side effects present at one year

4 Study Design Multi-centre randomised controlled trial with a pragmatic design 3 year recruitment period with a 1 year follow up for each patient – visits at baseline and weeks 3, 6, 13, 26, 39 and 52 256 patients will be recruited, approx 156 from the UK (40 sites) and 100 from Germany (7 sites) 7 patients recruited at each site Investigator is single – blind for the first 6 weeks but after this is free to amend the dose of the trial medication

5 Prednisolone 0.5mg/kg/day (to be given as a single dose each morning) or Doxycycline 200mg (once a day) Mometasone furoate (Elocon) cream or ointment (0.1%) permitted as rescue medication. Applied to blisters / lesions for first 3 weeks and weeks 6 - 52of study

6 Aged 18+ and able to give informed consent Clinical diagnosis of bullous pemphigoid At least 3 significant blisters or erosions over 2 or more body sites No previous episodes of bullous pemphigoid or treatment for BP for previous year (topical steroids allowed) Mainly or entirely mucosal pemphigoid

7 The research question developed from a thorough literature search supported by clinical impression of experts in the field Trial developed by the UK DCTN - rigorous process Funded by the National Institute for Health Research - highly competitive International collaboration will ensure sufficient recruitment and support from leaders in the field How do we know its a trial worth doing?

8 Refer to a dermatologist who is involved with BLISTER OR Contact Caroline, the trial manager on 0115 884 4925/ 07989 206252 Please dont prescribe any oral therapy before the patient has been assessed for the trial. You can prescribe Elecon cream or ointment if required. Website:

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