A randomized clinical trial of topical dexamethasone vs. cyclosporine treatment for oral lichen planus

Abstract

Background Oral lichen planus (OLP) is a common, frequently symptomatic, immune-mediated disease. Various treatments have been used for symptomatic OLP, including corticosteroids and immunosuppressants administered topically or systemically. The aim of this study was to compare the effectiveness of topical dexamethasone vs. topical cyclosporine in treatment of symptomatic OLP. Material and Methods Thirty-two patients with biopsy-proven symptomatic OLP were randomly assigned to two therapeutic groups: dexamethasone 2mg/5ml or cyclosporine 100mg/ml, both administered topically in a swish and spit method three times a day for 4 weeks. The patients were followed up for a total of 6 months. Assessed parameters included clinical scoring (according to Thongprasom’s scale, 0-5), pain (VAS scale, 0-10), dysphagia and speech difficulties (none, mild or severe). Possible side effects, including fungal overgrowth, were also recorded. Results At the end of the 4-week treatment period, both dexamethasone and cyclosporine showed a statistically significant improvement in clinical scoring ( p <0.025 and p =0.034, respectively), which was better with dexamethasone ( p =0.001). In addition, both dexamethasone and cyclosporine induced statistical significant improvement in pain and dysphagia (and speech difficulties for dexamethasone), without significant differences between the two groups. Regarding side effects, patients in the dexamethasone group developed candidiasis more frequently compared to cyclosporine ( p =0.031). At the end of the 6-month follow-up period, the difference in response between the two groups was not statistically significant. Interestingly, a trend for further improvement compared with the end of the 4-week treatment period was noticed only for patients treated with cyclosporine. Conclusions Despite the small number of enrolled patients, topical cyclosporine treatment induces a significant clinical improvement in symptomatic OLP patients, which, compared to topical dexamethasone, appears to be less pronounced during initial administration, but capable to induce further improvement after discontinuation with a satisfactory long-term remission in the absence of significant side effects. This study may contribute to a better understanding of the differences in effectiveness of OLP topical treatments and guide future larger scale clinical trials. Key words: Oral lichen planus, topical treatment, dexamethasone, cyclosporine.

A systematic review of the efficacy and safety of topical cyclosporine in dermatology

“…Georgaki et al, 25 revealed the results of a randomized controlled clinical trial (RCT), comparing topical dexamethasone with topical Cyc‐A in the treatment of OLP in 32 patients. The trial was conducted for 4 weeks, and patients were followed up for further 5 months after finishing their treatment period.…”

“…In general, topical Cyc-A can be considered a safe alternative medication for many mucocutaneous ailments as no cases of severe adverse effects were observed. However, more adverse effects such as dysphagia, dyspepsia, burning sensation, lips swelling, gastrointestinal upset were reported as the side effect of mouthwash Cyc-A, 25,27,29 and topical application of Cyc-A lipogel on the skin resulted in cases of mild erythema, dryness, and fissuring. ments or in locations such as face, folds, and genital, where penetration is much higher than elsewhere.…”

Efficacy of topical administration for oral lichen planus: A network meta‐analysis

“…Data from 16 RCTs (P. Arduino et al., 2018; P. G. Arduino et al., 2013; Arunkumar et al., 2015; Azizi & Lawaf, 2007; Georgaki et al., 2010; Gorouhi et al., 2007; Hettiarachchi et al., 2017; Liu et al., 2013; Pakfetrat et al., 2015; Revanappa et al., 2012; Riaz et al., 2017; Y. L. Sun et al., 2013; Swift et al., 2005; K. Thongprasom et al., 2007; Yoke et al., 2006; Zuo et al., 2013) ( n = 759) with 11 direct pairwise comparisons among 9 interventions were pooled after 2–8 weeks treatment (13 RCTs with 3–4 weeks treatment, 2 RCTs with 2 weeks treatment and 2 RCTs with 6–8 weeks treatment). NMA estimates (defined as SMD and 95% CI; Table ) indicated that CLO, DEX, PIM and TAC were significantly better than PBO in symptom reduction in OLP patients.…”

“…Data from 10 RCTs (P. Arduino et al., 2018; P. G. Arduino et al., 2013; Arunkumar et al., 2015; Azizi & Lawaf, 2007; Georgaki et al., 2010; Gorouhi et al., 2007; Hettiarachchi et al., 2017; Pakfetrat et al., 2015; Riaz et al., 2017; K. Thongprasom et al., 2007) ( n = 361) with 7 direct pairwise comparisons among 7 interventions were pooled after 3–8 weeks of treatment (9 RCTs with 3–4 weeks treatment and one RCT with 8 weeks treatment). NMA estimates (defined as SMD and 95% CI) showed that the six included interventions were significantly better than PBO, and no significant differences were observed among the six interventions (Table ).…”

“…Data from 16 RCTs (P. Arduino et al, 2018;P. G. Arduino et al, 2013;Arunkumar et al, 2015;Azizi & Lawaf, 2007;Georgaki et al, 2010;Gorouhi et al, 2007;Hettiarachchi et al, 2017;Liu et al, 2013;Pakfetrat et al, 2015;Revanappa et al, 2012;Riaz et al, 2017;Y. L. Sun et al, 2013;Swift et al, 2005;K.…”