title: 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.
abstract: 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.
  
  
  OBJECTIVE
  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.
authors: Centre of Evidence Based Dermatology, University of Nottingham, King's Meadow Campus Lenton Lane, Nottingham, NG7 2NR, U.K.
authors: J R
authors: JR
authors: Chalmers
authors: Nuffield Department of Clinical Medicine, Oxford University, Oxford, OX3 7BN, U.K.
authors: F
authors: F
authors: Wojnarowska
authors: Centre of Evidence Based Dermatology, University of Nottingham, King's Meadow Campus Lenton Lane, Nottingham, NG7 2NR, U.K.
authors: G
authors: G
authors: Kirtschig
authors: Medical Research Council Clinical Trials Unit, Aviation House 125 Kingsway, London, WC2B 6NH, U.K.
authors: A J
authors: AJ
authors: Nunn
authors: Medical Research Council Clinical Trials Unit, Aviation House 125 Kingsway, London, WC2B 6NH, U.K.
authors: D J
authors: DJ
authors: Bratton
authors: School for Medicine, Pharmacy and Health, Wolfson Research Institute, Durham University, Stockton on Tees, TS17 6BH, U.K.
authors: J
authors: J
authors: Mason
authors: Nottingham Clinical Trials Unit, Nottingham Health Science Partners, C Floor South Block, Nottingham, U.K.
authors: K A
authors: KA
authors: Foster
authors: Nottingham Clinical Trials Unit, Nottingham Health Science Partners, C Floor South Block, Nottingham, U.K.
authors: D
authors: D
authors: Whitham
authors: Centre of Evidence Based Dermatology, University of Nottingham, King's Meadow Campus Lenton Lane, Nottingham, NG7 2NR, U.K.|Dermatology Department, Queen's Medical Centre, University of Nottingham, Nottingham, NG7 2UH, U.K.
authors: H C
authors: HC
authors: Williams
mesh_terms: D000284:Administration, Oral; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004318:Doxycycline / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D006801:Humans; D010391:Pemphigoid, Bullous / Q000188:drug therapy*; D011239:Prednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents; D011239:Prednisolone; D004318:Doxycycline