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. 2010 Oct 6;2010(10):CD002292. doi: 10.1002/14651858.CD002292.pub3

Joly 2002.

Methods Randomised, not blinded
Disease control = number of new blisters after 3 weeks (21 days) of treatment. (Not clear if participant kept record of new blisters daily or if all new blisters since previous visit were averaged out to get a daily rate)
Participants 341 participants with BP confirmed by IF studies
Interventions Moderate disease:
A: 40 g topical clobetasol propionate cream twice daily to entire body 77/77 versus 0.5 mg/kg/day oral prednisone 76/76.
Extensive disease:
A: topical clobetasol 93/93 versus prednisone 1 mg/kg/day 95/95.
Outcomes
  1. Major outcome: survival

  2. Disease control at 3 weeks

  3. Complications

Notes Originally there were 364 participants recruited: 14 did not meet the inclusion criteria, 8 did not give consent, 1 withdrew his consent in the beginning of the study: left with 341 study participants
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was performed centrally with the use of random numbers in permuted blocks of four within each stratum." (Page 322)
Allocation concealment (selection bias) Unclear risk Allocation concealment is not well described. Probably adequate as it was done centrally.
Blinding (performance bias and detection bias) 
 All outcomes High risk The study was not blinded. A nurse not otherwise associated with the study assessed the number of new bullae, daily.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participants and outcomes adequately reported.
Selective reporting (reporting bias) Low risk Adequately reported.
Other bias Unclear risk Quote: "In accordance with the study protocol, the investigators switched three patients with moderate bullous pemphigoid and four with extensive bullous pemphigoid from the oral‐prednisone group to the topical‐corticosteroid group because of side‐effects of treatment." (Page 324) 'Compliance with treatment and adverse effects'.