This is a randomised controlled trial to compare the safety and effectiveness of doxycycline (200 mg/day) with prednisolone (0.5 mg/kg/day) for the initial treatment of bullous pemphigoid.  Click here to see the Blister Study synopsis.

Details of the disease

Bullous pemphigoid is a skin condition affecting mainly the elderly, which causes tense, itchy blisters and painful skin erosions that can affect the whole body.  It is a severe autoimmune blistering disease associated with significant morbidity and mortality, which cannot be left untreated. 

The proposed research

Bullous Pemphigoid is usually treated with long-term oral prednisolone which can cause many unwanted side effects such as high blood pressure, osteoporosis, infections and diabetes.  A safer alternative treatment is sought for this condition.  This study will determine whether doxycycline (a member of the tetracycline family) would be a useful alternative to prednisolone for treating bullous pemphigoid i.e. do the benefits of less severe side effects outweigh any potential reduction in effectiveness.

In this study, patients will be randomised to receive either prednisolone or doxycycline. To help prevent bias, the investigator will not know which treatment the patient has been given until after assessment of the primary efficacy outcome.  After six weeks, the investigator will count the number of blisters that remain.  The investigator will then be informed about the treatment allocation.  The medication dose will then be assessed every few weeks and reduced if appropriate until the blisters have virtually all cleared.  To assess safety, all adverse events will be recorded for a year after starting the study.

Outcome measures:

1. Proportion of patients who have five or less significant blisters at six weeks. 

2:  Proportion of patients with grade 3 or above side effects (inc. mortality) at one year.

Recruitment

Adults with bullous pemphigoid who have received no treatment for this condition in the past year will be enrolled into this study.   The study will have approximately 40 active recruiting centres in the UK, Germany and the Netherlands and aims to recruit a total of 256 patients over a three year period.  If you are interested in recruting to this study please contact the Senior Clinical Trials Manager or email blister@nottingham.ac.uk

Funding

BLISTER has been funded by the NIHR Health Technology Assessment (HTA).