Campisi 2004.
Methods | Study design: RCT Conducted in Italy Number of centres: 1 Recruitment period: unclear Funding source: unspecified |
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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 |
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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 |
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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. |