ORAL HEALTH EVIDENCE-BASED PRACTICE PROGRAM
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Title Topical Tacrolimus is Equally Effective in Treating Patients with Oral Lichen Planus (OLP) as Compared to Topical Clobetasol
Clinical Question Can topical tacrolimus be used as an alternate to topical clobetasol for treatment of OLP?
Clinical Bottom Line In patients with OLP, topical treatment with clobetasol and tacrolimus are equally effective in reducing symptoms. However, some studies suggest that topical tacrolimus may have higher efficacy.
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 23067089Sonthalia/2012n = 40RCT
Key results40 patients were enrolled with histologically proven diagnosis of OLP. The patients were randomly divided into 2 groups: twenty patients were assigned the use of clobetasol propionate (0.05%) ointment (topical corticosteroid) twenty patients were assigned the use of tacrolimus (0.1%) ointment (topical immunosuppressant), for eight weeks each. The patients were instructed to apply the ointment twice a day during the treatment period. Both groups were additionally instructed to use chlorhexidine mouthwash three times per day during the 8 week period. All patients were assessed at 2 weeks, 4 weeks and 8 weeks and at one post treatment visit at 12 weeks. Treatment was assessed based on the area involved and the severity of OLP lesions. 70% of patients in the clobetasol group achieved complete or partial response at 8 weeks, as compared to 95% in the tacrolimus group (p=0.091). There was improvement in patient reported symptoms, although the difference between the groups was not statistically significant (p > 0.05). The study concluded that topical application of 0.05% clobetasol and 0.1% tacrolimus were both effective in treating OLP. Limitations of this study include its small sample size and short duration.
#2) 18230389Radfar/2008n = 30 RCT
Key resultsThis study recruited 30 patients with lesions that were rendered a clinical and histological diagnosis of oral lichen planus. Patients were randomly assigned to 2 treatment groups; fifteen patients received treatment with clobetasol 0.05% ointment and fifteen patients received treatment with tacrolimus 0.1% ointment, each for 6 weeks. Both groups were instructed to apply the ointment 4 times/day for 2 weeks followed by 3 times/day for 2 weeks, 2 times/day for 1 week, and 1 time/day for 1 week. All patients were asked to rinse with nystatin 1 time/day during the treatment period in order to prevent oral candidiasis. All patients had 3 visits, which consisted of measuring the lesion, and a pain assessment evaluation using a visual analog scale (VAS). After 6 weeks of treatment, the mean reduction in lesion size was 82.6% in the tacrolimus group, and 81.6% in the clobetasol group. VAS scores after 6 weeks of treatment suggested improvement (p< .0001), however there was no statistical difference in improvement in symptoms between the two groups. The study concluded that topical application of tacrolimus is as effective as clobetasol in the treatment of OLP.
#3) 18269664Corrocher /2008n= 32RCT
Key resultsThis study recruited 32 patients with histologically confirmed OLP. Patients were randomly assigned to two treatment groups; sixteen patients received 2ml of tacrolimus 0.1% ointment, and sixteen patients received 2ml of clobetasol propionate 0.05% ointment. Both groups were instructed to apply the topical medication four times daily for 4 weeks. Patients were evaluated at 3 points: a) baseline assessment, b) 4 weeks after initiating treatment, c) 6 weeks after initiating treatment. Mucosal lesional extension and symptoms of pain and burning were assessed during the three visits using a four-point scale. Prior to initiating treatment, there was no statistically significant difference in scores corresponding to pain, burning and mucosal extension between the two groups. At the end of 4 weeks of treatment and follow-up at 6 weeks, the median scores for pain, or burning sensation, and mucosal extension were significantly lower in the tacrolimus group as compared to the clobetasol group (p < 0.001). The study concluded that topical tacrolimus 0.1% ointment was significantly more effective in treating OLP as compared to topical clobetasol propionate 0.05% treatment.
Evidence Search ("tacrolimus"[MeSH Terms] OR "tacrolimus"[All Fields]) AND ("lichen planus, oral"[MeSH Terms] AND ("clobetasol"[MeSH Terms] OR "clobetasol"[All Fields])
Comments on
The Evidence
There are limited clinical trials comparing the efficacy of topical tacrolimus and topical clobetasol in patients with OLP. Clobetasol is a potent topical steroid that helps reduce symptoms of OLP because of its anti-inflammatory properties. Tacrolimus is an immunomodulator that inhibits T cell activation by blocking calcineurin. The results from these studies have concluded that tacrolimus is at least as effective, or possibly more effective than topical clobetasol in the treatment of OLP. Limitations of these studies include the short duration of the treatment period and follow-up, small sample of patients, and lack of a placebo control group. These studies are considered to have a moderate level of evidence and multiple long-term studies are needed to verify and support the current findings. A potential limitation in using tacrolimus as one of the first line therapies in the management of OLP is that there have been concerns about tacrolimus having carcinogenic potential based on animal studies and case reports. Because of this, the U.S. Federal Drug Administration (FDA) issued a warning to health care providers and patients about the potential cancer risk in 2005.
Applicability Oral Lichen Planus is a T-cell mediated autoimmune condition. The incidence is reported to be approximately 0.5% - 2%. Although a few patients with OLP remain asymptomatic, a majority present with erythematous and erosive lesions affecting the oral cavity. Topical steroids remain the treatment of choice for patients with symptomatic OLP. The use of topical immunosuppressive drugs can be recommended in patients unresponsive to topical steroids.
Specialty/Discipline (Oral Medicine/Pathology/Radiology) (General Dentistry)
Keywords Oral Lichen Planus, clobetasol, tacrolimus, topical
ID# 2490
Date of submission: 06/10/2013spacer
E-mail pallavi.parashar@ucdenver.edu
Author Pallavi Parashar
Co-author(s)
Co-author(s) e-mail
Faculty mentor/Co-author Robert O. Greer, DDS, ScD
Faculty mentor/Co-author e-mail Robert.Greer@ucdenver.edu
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