title: Clinical and serological efficacy of topical calcineurin inhibitors in oral lichen planus: a prospective randomized controlled trial.
abstract: Oral lichen planus (OLP) is a T-cell-mediated disease characterized by immune-mediated basal cell degeneration releasing interleukins (ILs) such as IL-6 and IL-8 into the circulation. Their serum levels reportedly reflect disease activity. Although many therapeutic options are available, none are curative. We compared the efficacy of tacrolimus 0.1% ointment and pimecrolimus 1% cream in OLP and correlated with serum IL-6 and IL-8 levels before and after treatment. Forty patients with symptomatic OLP were randomized into two groups, to receive either topical tacrolimus 0.1% ointment or pimecrolimus 1% cream (twice daily for 8 weeks). Patients were assessed at 2, 4, 8, and 12 weeks. At each visit, objective improvement in the net clinical score (NCS), drug tolerability, and side effects were evaluated. Serum IL-6 and IL-8 levels were measured at baseline and at eight weeks. Baseline characteristics were comparable between the groups. The mean NCS declined from 10.9 ± 4.5 and 9.9 ± 4.6 at baseline to 5.4 ± 3.5 and 5.3 ± 4.2 at 12 weeks for tacrolimus and pimecrolimus group, respectively. At each visit, in both groups, the decline in mean NCS from baseline was statistically significant (P < 0.05) and so was the decline in mean serum IL-6 and IL-8 levels pre- and post-treatment. Pimecrolimus 1% cream seems to be as effective as tacrolimus 0.1% ointment. Serum IL-6 and IL-8 may act as markers of disease activity. However, future efforts are needed to objectify the use of serum interleukin levels in the disease severity index.
authors.affiliation: Department of Dermatology & STD, University College of Medical Sciences & GTB Hospital (University of Delhi), Dilshad Garden, India.
authors.forename: Suruchi
authors.initials: S
authors.lastname: Vohra
authors.affiliation: Department of Dermatology & STD, University College of Medical Sciences & GTB Hospital (University of Delhi), Dilshad Garden, India.
authors.forename: Archana
authors.initials: A
authors.lastname: Singal
authors.affiliation: Department of Biochemistry, University College of Medical Sciences & GTB Hospital (University of Delhi), Dilshad Garden, India.
authors.forename: Suman Bala
authors.initials: SB
authors.lastname: Sharma
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000704:Analysis of Variance; D065095:Calcineurin Inhibitors / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015850:Interleukin-6 / Q000097:blood; D016209:Interleukin-8 / Q000097:blood; D017676:Lichen Planus, Oral / Q000097:blood* / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016559:Tacrolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D065095:Calcineurin Inhibitors; D015850:Interleukin-6; D016209:Interleukin-8; C117268:pimecrolimus; D016559:Tacrolimus