A randomized controlled trial to compare the safety and effectiveness of doxycycline (200 mg daily) with oral prednisolone (0.5 mg kg(-1) daily) for initial treatment of bullous pemphigoid: a protocol for the Bullous Pemphigoid Steroids and Tetracyclines (BLISTER) Trial

J R Chalmers, F Wojnarowska, G Kirtschig, A J Nunn, D J Bratton, J Mason, K A Foster, D Whitham, H C Williams, BLISTER Study Group

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21 Citations (Scopus)


BACKGROUND: Bullous pemphigoid (BP) is the most common autoimmune blistering disease in older people, and is associated with significant morbidity and mortality. Oral corticosteroids are usually effective but the side-effects are thought to contribute to the high morbidity and mortality rate. Treatment with oral tetracyclines may be effective but high-quality, randomized controlled trials (RCTs) are needed to confirm this.

OBJECTIVES: To compare the effectiveness and safety of two strategies for treating BP.

METHODS: This is a two-arm, parallel group, 52-week RCT comparing doxycycline with prednisolone for initial treatment of BP. Dose is fixed for the initial 6 weeks of treatment (doxycycline 200 mg daily; prednisolone 0.5 mg kg(-1) daily), after which it can be adjusted according to need. A total of 256 patients with BP will be recruited in the U.K. and Germany.

RESULTS: The primary outcomes are: (i) effectiveness (assessor-blinded blister count at 6 weeks) and (ii) safety [proportion of patients experiencing ≥ grade 3 adverse events (i.e. severe, life: threatening or fatal) related to trial medication during the year of follow-up]. Primary effectiveness analysis will be an assessment of whether doxycycline can be considered noninferior to prednisolone after 6 weeks of treatment. Primary safety analysis is a superiority analysis at 12 months. Secondary outcomes include longer-term assessment of effectiveness, relapse rates, the proportion of patients experiencing any grade of adverse events related to treatment, quality of life and cost-effectiveness.

CONCLUSIONS: The trial will provide good evidence for whether the strategy of starting BP treatment with doxycycline is a useful alternative to prednisolone.

Original languageEnglish
Pages (from-to)227-234
Number of pages8
JournalBritish Journal of Dermatology
Issue number1
Early online date26 May 2015
Publication statusPublished - Jul 2015


  • Dermatologic Agents
  • Doxycycline
  • Drug Administration Schedule
  • Humans
  • Bullous Pemphigoid
  • Prednisolone
  • Recurrence
  • Treatment Outcome
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

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