ISRCTN13704604.

Trial name or 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
Methods	Prospective, 2‐arm, single‐blind, parallel group, multicentre randomised controlled trial
Participants	256 participants with bullous pemphigoid, confirmed by immunofluorescence tests
Interventions	Doxycycline (200 mg/day) versus prednisolone (0.5 mg/kg/day)
Outcomes	Primary: Proportion of participants classed as treatment success (3 or less significant blisters present on examination) at 6 weeks Number of reported grade 3, 4, and 5 (mortality) adverse events for 1 year Secondary: Differences in the 2 treatment arms in the: Proportion of participants classed as treatment success (3 or less significant blisters present on examination) at 6 weeks and are alive at 1 year Proportion of participants classed as treatment success (3 or less significant blisters present on examination) after 3 and 12 months of treatment Proportion of participants who have a further episode of bullous pemphigoid during their participation in the study after previously being classed as a treatment success Number of reported grade 1 and 2 adverse events for 1 year following the start of study treatment Quality of life Cost‐effectiveness Tertiary: Differences in the 2 treatment arms in the: Proportion of participants who, on examination at 6 weeks, are completely blister‐free Proportion of participants who are alive 1 year after the start of study treatment Proportion of participants in each treatment arm who, on examination at 3 weeks, are classed as treatment success (3 or less significant blisters present) Difference in the amount of potent and super‐potent topical corticosteroids used
Starting date	March 2009
Contact information	Mrs Caroline Onions (blister@nottingham.ac.uk) Clinical Trials Unit Office, B39 Medical School Queens Medical Centre Nottingham NG7 2UH England
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