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Clinical and serological efficacy of topical calcineurin inhibitors in oral lichen planus: a prospective randomized controlled trial
Author(s) -
Vohra Suruchi,
Singal Archana,
Sharma Suman Bala
Publication year - 2016
Publication title -
international journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.677
H-Index - 93
eISSN - 1365-4632
pISSN - 0011-9059
DOI - 10.1111/ijd.12887
Subject(s) - pimecrolimus , tacrolimus , medicine , calcineurin , oral lichen planus , tolerability , randomized controlled trial , gastroenterology , clinical trial , dermatology , protein synthesis inhibitor , adverse effect , transplantation , antibacterial agent , microbiology and biotechnology , biology , antibiotics
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.