Joly 2009.

Methods	Multicentre in France, centrally randomised; not blinded 2 different regimens were applied. In the mild regimen participants received doses depending on their body weight; follow‐up of 360 days
Participants	312 participants with bullous pemphigoid; confirmed by direct immunofluorescence test
Interventions	Mild regimen: clobetasol propionate cream 10 to 30 g/day, until 15 days after disease control, thereafter corticosteroid tapering over 4 months (159) moderate disease (≤10 new blisters/day): 20 g/day if body weight > 45 kg, 10 g/day if < 45 kg severe disease (>10 new blisters/day): 30 g/day if body weight > 45 kg, 20 g/day if < 45 kg. Standard regimen: clobetasol propionate cream 40 g/day initially, until 15 days after disease control, corticosteroid tapering over 12 months (page 1686) (153 participants).
Outcomes	Primary: Complete healing (no new bullae for 3 consecutive days) after 21 days (moderate disease ‐ severe disease) Death/event‐free survival after 1 year (moderate disease ‐ severe disease) Secondary end points: Time to achieve disease control Occurrence of severe (grade 3 or 4) side‐effects (adverse events requiring hospitalisation or prolongation of hospitalisation or life‐threatening events) during the follow‐up year Occurrence of relapses during follow‐up Cumulative doses of clobetasol propionate cream used during the study period
Notes	Page 1686 typing error: should be 0.05% clobetasol propionate cream, not 0.005% Discrepancy between the numbers of participants as follows: the numbers in figure 1 (153 participants randomised, 150 participants analysed), text (153 participants randomised, 150 participants analysed), and table 2 (153 randomised and 153 analysed) for the standard regimen do not match Clarification from the study investigator (Joly 2010): numbers in table 2 on page 1684, are wrong, should be 150 in the standard regimen Only 150 were analysed, therefore intention‐to‐treat (ITT) analysis is not fulfilled Worst case scenario calculation (none of the 3 missing cases in the standard group had complete healing): ‐ 156/159 v 150/153 (ITT analysis), Analysis 8.1
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 1686)
Allocation concealment (selection bias)	Low risk	Allocation concealment is not well described. Probably adequate as it was done centrally.
Blinding (performance bias and detection bias) All outcomes	High risk	Intentionally not blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not all participants were accounted for at each stage of the trial. See Figure 1, page 1683, and Table 2, page 1686: typing error in table 2, only 150 participants were analysed.
Selective reporting (reporting bias)	Low risk	All outcomes reported adequately.
Other bias	Low risk	No other bias.