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.

Clinical Management of Oral Lichen Planus: A Systematic Review

“…All 25 examined studies were randomized controlled trials; 22 of these were parallel group studies, 1 was a crosssectional study [21] and 2 were split-mouth design studies [11,12]. Furthermore, 4 were single-blind studies [14,19,24,25] and 9 were double-blind studies [10,16,[20][21][22][23][26][27][28]. Table 1 and Fig.…”

“…The outcomes evaluated regarding these therapeutic approaches were different; in relation to the symptomatologygenerally characterized by a burning sensation and pain -the majority of studies evaluated symptoms by using the Visual Analog Scale (VAS), and 4 studies used the Numerical Rating Scale (NRS) [10,11,18,19]. Only two studies did not consider symptomatology as an outcome [15,27], while the results of one study were based exclusively on evaluating the improvement of symptoms, using the VAS [13].…”

“…Among all the studies, 7 compared active treatment with a placebo [10,20,21,23,28,29], and one of these studies compared placebos with multiple treatments [30]. A total of 14 clinical trials compared two different active treatments [11-13, 15-18, 22, 26, 27, 31-34]; 3 studies compared two different drugs belonging to the same class [19,26,27]; finally, one study compared two different routes of administration of the same drug [14].…”

“…In the analysed literature, the most frequently recurrent therapy was based on the use of topical corticosteroids [12-19, 22, 24, 25, 30-34], followed by photo-dynamic therapy [13,17,30,[32][33][34], then by treatment with calcineurin inhibitors, such as tacrolimus and pimecrolimus [15,16,26,27,31], and finally by topical therapy with curcumin gel [18,22,23]. We also observed the use of various other types of intervention, namely cryotherapy [12], ozone therapy [30], excisional surgery [11], inhibitors of neo-angiogenesis [24], tocopherol [21], hydroxychloroquine [10], chamomile [28], hyaluronic acid [29], and Gluscosides of Paeony Capsule (GPC) [25].…”

The Effectiveness of Topical Pimecrolimus in the Treatment of Oral Lichen Planus

“…A recent randomized controlled study (23) suggested that pimecrolimus 1% cream is equally effective as tacrolimus 0.1% ointment in OLP. No severe adverse effects necessitating stopping treatment were observed in the two groups.…”