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A randomised, controlled trial to compare prednisolone with
doxycycline
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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
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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
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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
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256 patients will be recruited from UK (approx 45 sites)
and Germany (7 sites)
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7 patients recruited at each site over the course of the trial
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Investigator is single – blind for the first 6 weeks but after
this is free to amend the dose of the trial medication
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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
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Aged 18+ and able to give informed consent
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Clinical diagnosis of bullous pemphigoid
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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)
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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)
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Mainly or entirely mucosal pemphigoid
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Live virus vaccine in the last three months
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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
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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
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201 Patients recruited up to 16th May
Extension bid successful – now
recruiting up to September 2013
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Refer to a dermatologist who is involved with BLISTER
OR
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