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. 2020 Feb 28;2020(2):CD001168. doi: 10.1002/14651858.CD001168.pub3

Conrotto 2006.

Methods Study design: RCT
Conducted in Italy
Number of centres: 1
Recruitment period: 1999–2002
Funding source: company provided drugs
Participants Inclusion criteria: clinical and histological OLP; painful lesions
Exclusion criteria: presence of histological signs of dysplasia; use of lichenoid reaction‐inducing drugs; presence of amalgam fillings close to lesions; therapy for OLP in the 6 months prior to the study; skin, genital or other extraoral lesions; pregnant or breastfeeding women
Group A: randomised 20; analysed 19
Group B: randomised 20; analysed 20
Interventions Group A: clobetasol propionate 0.025% in 4% hydroxyethyl cellulose gel, twice daily for 2 months
Group B: ciclosporin 1.5% in 4% hydroxyethyl cellulose gel, twice daily for 2 months
Outcomes Pain resolution, clinical score (Thongprasom), adverse effects, cost
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "computer‐generated random number tables."
Allocation concealment (selection bias) Low risk Authors implied that the allocation list was hidden and allocation performed by pharmacy.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "double blind"; however, ciclosporine has a distinct foul taste so assessed as 'unclear'
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "double blind."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: missing data not likely to have a clinically relevant impact on the intervention effect estimate (1 participant from Group A). Unlikely to have introduced bias.
Selective reporting (reporting bias) Low risk Planned outcomes reported.
Other bias Low risk No other sources of bias identified.