Oral Biosci Med 2 (2005), No. 4 27. Jan. 2006
Oral Biosci Med 2 (2005), No. 4 (27.01.2006)
Topical Tacrolimus in Erosive Oral Lichen Planus: An Effective Treatment Approach
Eckardt, A./Völker, B./Starke, O./Kaever, V./Kapp, A.
Objective: Lichen planus is a chronic mucocutaneous disease with primary or secondary involvement of the oral mucosa. In particular in erosive lichen planus most patients experience no long-term symptom relief of conventional topical treatment such as corticosteroid ointments. Topical tacrolimus application to mucosal lesions seem to be an innovative treatment approach. We present data of a clinical phase-II study in patients with erosive lichen planus.
Patients and methods: A total of 18 patients (13 females, 5 males; mean age 64,5 years) have been recruited so far. All patients had a verified diagnosis of erosive lichen planus and had been intermittendly on local corticosteroid treatment without long-term benefit. Patients were instructed to self-administer tacrolimus 0.1% ointment on involved mucosal surfaces twice daily. Treatment period was 8 weeks with a follow-up period of 14 weeks. Blood levels of tacrolimus were assessed using an on-line SPE/HPLC/MS/MS system.Treatment response was assessed by visual analog scale (VAS range 0 - 10; 0=pain free, 10= severe pain). Treatment response was also assessed on mucosal biopsies with immunohistochemical staining for CD3, CD 4, CD 8, CD 68, CD79a and S100.
Results: Objective response rate was 100%, with a complete remission of 55%. Treatment response assessed by VAS scale revealed a significant decrease of VAS 5,96± 0.69 (week 0) to VAS 2,68±0,39 (week 8) (p=0.000). All biopsies showed a strong decrease of inflammatory cells supporting the immunomodulating effect of tacrolimus.
Conclusions: Topical tacrolimus ointment is a safe and very effective treatment approach for erosive lichen planus and deserves further investigation.
Keywords: erosive oral lichen planus, tacrolimus, SPE/HPLC/MS/MS system, phase-II study, cytokines