Campisi 2004.

Methods	Study design: RCT Conducted in Italy Number of centres: 1 Recruitment period: unclear Funding source: unspecified
Participants	Inclusion criteria: clinical diagnosis of symptomatic atrophic/erosive OLP; histological confirmation of OLP; naive status (no previous treatment for OLP in last 6 months); willingness (written informed consent) and ability to complete the trial Exclusion criteria: histological presence of dysplasia; use of drugs associated with lichenoid reactions; contemporary skin or genital lesions (or both), pregnancy, immunodysfunction and haematological disease Group A: randomised 20; analysed 18 Group B: randomised 30; analysed 27
Interventions	Group A: clobetasol propionate in microspheres 0.025%, 2 applications daily for the first month and 1 application daily for the second month Group B: clobetasol propionate 0.025% in a dispersion of a lipophilic ointment in a hydrophilic phase, 2 applications daily for the first month and 1 application daily for the second month
Outcomes	Pain (VAS), clinical score (Thongprasom), adverse effects
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: insufficient information to permit judgement.
Allocation concealment (selection bias)	Unclear risk	Comment: insufficient information to permit judgement.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not feasible.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: participants (self‐assessed, pain was primary outcome) were not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: missing data balanced in numbers across intervention groups (2 and 3) and unlikely to have a clinically relevant impact on the intervention effect estimate. Unlikely to have introduced bias.
Selective reporting (reporting bias)	Low risk	Planned outcomes reported.
Other bias	Low risk	No other sources of bias identified.