A randomised, controlled trial to compare prednisolone with doxycycline

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

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

Multi-centre randomised controlled trial with a pragmatic design which opened in Feb 2009

4.5 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 from UK (approx 45 sites) and Germany (7 sites)

7 patients recruited at each site over the course of the trial

Investigator is single – blind for the first 6 weeks but after this is free to amend the dose of the trial medication

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

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 (eg. both legs) which have appeared in the last week

No previous episodes of bullous pemphigoid or treatment for BP in the previous year (topical steroids allowed)

Has taken oral treatment for bullous pemphigoid in the last year, or steroids for any other condition in the last 12 weeks (but if the patient is likely to need steroids in the coming year for a chronic condition they should not be randomised)

Mainly or entirely mucosal pemphigoid

Live virus vaccine in the last three months

Any other condition or allergy which precludes the use of either study drug or would deem them unsuitable in the opinion of the investigator

Participating in another clinical trial

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

50 UK sites and 7 German sites 3 further sites being opened

201 Patients recruited up to 16th May

Extension bid successful – now recruiting up to September 2013

Refer to a dermatologist who is involved with BLISTEROR

Contact the trial manager (Katharine Foster) on 0115 884 4925

Please don’t prescribe any oral therapy before the patient has been assessed for the trial. You can prescribe Elecon cream or ointment if required.

Website: www.blistertrial.co.uk