Evaluation of Muco Adhesive Tacrolimus Patch on Caspase-3 Inducing Apoptosis in Oral Lichen Planus (A Randomized Controlled Clinical Trial with Immuno Histochemical Analysis)

Abstract

The present study was conducted on thirty patients suffering from erosive or atrophic OLP, to evaluate efficacy of muco-adhesive tacrolimus patch compared to tacrolimus/corticosteroid gel and their effect on caspase-3. Patients were randomly assigned blinded in three equal groups to receive tacrolimus 0.1% patch (Group I) 2 times daily for 2 months, tacrolimus 0.1% gel (Group II) and triamcinolone acetonide 0.1% (Group III) both are applied 4 times daily for 2 months and followed up for another treatment free one-month period. Photographs of the most severe lesion were taken (Marker lesion) in each patient and analyzed for Total Atrophic Area (TAA), patients were also assessed using clinical scores (CS) and visual analogue scale (VAS). Punch biopsy specimens were taken in two periods from each patient; at baseline and after 2 months’ treatment period, the total number of lesional lymphocytes were assessed in H/E-stained sections, while number and localization of caspase-3 immuno-positive cells were assessed in immune-stained sections. The present study reported that both drugs showed significant reduction in all clinical parameters after treatment termination, however, Group I showed the least mean CS and VAS in all visits in comparison to other groups, also group I and Group II showed initial significant reduction in VAS starting from the 2nd week and TAA starting from the 4th week while group III started to show significant reduction in VAS starting from the 4th week and in TAA starting from 8th week.