An RCT to compare prednisolone and doxycycline in bullous pemphigoid

• Research type

  Research Study

• Full title

  A randomised controlled trial to compare the safety and effectiveness of doxycycline (200 mg/day) with prednisolone (0.5 mg/kg/day) for initial treatment of bullous pemphigoid

• IRAS ID

  1089

• Contact name

  Hywel C Williams

• Sponsor organisation

  University of Nottingham

• Eudract number

  2007-006658-24

• Research summary

  Bullous pemphigoid (BP) is a skin condition affecting mainly the elderly, which causes tense, itchy blisters and painful skin erosions that can affect the whole body. Between 20% and 40% of patients die within 1 year of diagnosis. Treatment is normally long-term prednisolone tablets which can cause many unwanted side effects such as high blood pressure, osteoporosis (brittle bones), infections and diabetes which means a safer alternative treatment is needed for this condition. Tetracyclines are readily available, cheap and are have less side effects than prednisolone, but may be slightly less effective. This study will determine whether doxycycline (a member of the tetracycline family) would be a useful alternative to prednisolone for treating BP. Patients will be randomly given either prednisolone or doxycycline. To help prevent bias, the investigator will not know which treatment the patient has been given until after the blister count at 6 weeks. The medication will then be adjusted every few weeks until the blisters have virtually all cleared. To assess which drug is the safer, all adverse events will be recorded for a year after starting the study. The study will be carried out in hospitals by dermatologists in the UK, the Netherlands and Germany.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  08/H1008/174

• Date of REC Opinion

  12 Nov 2008

• REC opinion

  Further Information Favourable Opinion