Campisi 2004.

Methods	Phase IV, randomised, observer‐blinded, parallel group clinical trial Setting Section of Oral Medicine, Department of Oral Sciences, University of Palermo, Italy
Participants	Inclusion criteria of the trial Symptomatic atrophic/erosive OLP clinically and histology, no previous treatment in past 6 months Total n = 50 (lipid‐loaded microspheres 0.025% ‐ n = 20, conventional formulation ointment ‐ n = 30)
Interventions	Comparison of drug delivery system of clobetasol‐17‐propionate A: Lipid‐loaded microspheres 0.025% B: Conventional formulation lipophilic ointment in hydrophilic phase 0.025% Applied twice daily for 1 month then once daily for 1 month
Outcomes	Primary outcomes of the trial 1. VAS 0 to 100 2. Clinical score 0 to 5 (Thongprasom 1992) 3. Not assessed Secondary outcomes of the trial 1. Clinical resolution of index lesion Outcomes not prespecified in the protocol Compliance (nominal variables: good, sufficient, scarce)
Assessment points	Week 0, 4, and 8
Side‐effects reported	Oral candidiasis (1 in lipid‐loaded microspheres group, 2 in conventional ointment group)
Reported results	No significant difference between the 2 groups
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Block randomisation.
Allocation concealment (selection bias)	Unclear risk	Not specifically stated.
Blinding (performance bias and detection bias) Participants	High risk	Participants not blinded (different bases).
Blinding (performance bias and detection bias) Clinician	Low risk	Quote: "A single blind observer...different from the administrator..."
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Loss to follow‐up: 5 losses, 50 randomised. No ITT.
Selective reporting (reporting bias)	Low risk	All 4 outcomes reported.