An open trial of topical tacrolimus for erosive oral lichen planus

Morrison, Lynne; Kratochvil, Frank J.; Gorman, Annalisa

doi:10.1067/mjd.2002.126275

Cited by 86 publications

(59 citation statements)

References 16 publications

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“…However, the chronic nature of the autoimmune mucocutaneous diseases that are often associated with DG might require long-term (6-12 weeks) use of topical tacrolimus, which could be associated with immunosuppressant toxicity, including malignancy. 7,8,[12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28]35,36 The specific cause (ie, oral lichen planus, pemphigoid) of DG was not determined in the 24 patients in this study.…”

Section: Discussionmentioning

confidence: 99%

“…4,6 Topical tacrolimus at concentrations of 0.03%, 0.1%, and 0.3% has been associated with efficacy and tolerability in the treatment of inflammatory skin diseases 12-22 and has been used for oral diseases associated with autoimmune dermatoses. 7,8,[23][24][25] Moreover, studies 19,2° have found that the serum metabolites of tacrolimus were undetectable when the drug was used topically. The drug inhibits the activity of calcineurin, an important intracellular phosphatase and, thereby, T-lymphocyte activation.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of topical tacrolimus 0.1 % in pectin ointment with clobetasol 0.5% ointment in adults with moderate to severe desquamative gingivitis: A 4-week, randomized, double-blind clinical trial

Corrocher

Lorenzo

Mansueto

et al. 2006

Clinical Therapeutics

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Background: Desquamative gingivitis (DG) is a clinical condition characterized by red, painful, glazed, and friable gingiva, which might be a manifestation of some autoimmune mucocutaneous diseases. The time from the development of initial signs of DG to diagnosis can vary from months to years. Based on a literature search, no data concerning patients with DG without signs of autoimmune disease were available.Objective: The aim of this trial was to compare the efficacy and tolerability of monotherapy with topical tacrolimus 0.1% in pectin ointment versus clobetasol propionate 0.5% ointment in adults affected by DG.Methods: This randomized, double-blind clinical trial was conducted at the Dipartimento di Medicina Clinica e Sperimentale, Universitfi di Verona, Verona, Italy. Patients aged >18 years were selected using the department's electronic medical records based on a clinical diagnosis of moderate to severe DG. After a 2-week washout period, patients were randomly assigned to receive 2 mL of tacrolimus 0.1% in pectin (equivalent to 0.2 mg of tacrolimus) or 2 mL of clobetasol propionate 0.5% ointment (equivalent to 1 mg of clobetasol) QD for 4 weeks. Evaluations were performed before treatment (baseline), after the treatment period (week 4), and at 2 follow-up visits at weeks 6 and 8. The signs of DG (ie, erythema [atrophy] and desquamation [erosions/ulceration]) were quantified by a blinded investigator using a calculated score based on their surface extension, using a drawing in which the areas of various zones of the mouth were indicated as a percentage of the whole oral mucosa. Severity of erythema and desquamation was rated on a 4-point scale (0 = absent; 1 = involvement of <5% of surface [mild]; 2 = 5%-15% [moderate]; and 3 = >15% [severe]). The primary end point was the number of patients who achieved remission (severity score of 0) in either sign; the secondary end point was the proportions of patients achieving improvement (severity score of 0 or 1) in either sign. Before and after treatment, we measured the serum concentrations of tacrolimus and its metabolites with an immunoenzymatic assay kit. Tolerability was assessed using hematology, biochemistry, urinalysis, measurements of systolic/ diastolic blood pressure and heart rate, patient interview, and spontaneous reporting.Results: A total of 24 patients (18 women, 6 men; all white of Italian origin; age range, 21-65 years; 12 patients per treatment group) were enrolled in the study. In the tacrolimus group, 11 (91.7%) patients achieved remission of erythema and/or desquamation at weeks 4 and 6; at week 8, these rates were 9 (75.0%) and 8 (66.7%), respectively; none of the patients in the clobetasol group achieved remission of either sign at any time point (all, P < 0.001). At weeks 4, 6, and 8, significantly greater proportions of patients treated Accepted for publication September 13, 2006. 1296Volume 28 Number 9 G. Corrocher et al.with tacrolimus had improved erythema and desquamation compared with those treated with clobetasol (all...

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Comparison of topical tacrolimus 0.1 % in pectin ointment with clobetasol 0.5% ointment in adults with moderate to severe desquamative gingivitis: A 4-week, randomized, double-blind clinical trial

Corrocher

Lorenzo

Mansueto

et al. 2006

Clinical Therapeutics

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“…Regarding tacrolimus, its efficacy has been evaluated by several open-label prospective studies [15,16], randomized trials [67,68], retrospective studies [69,70], case series [71,72] and case reports [70]. Topical tacrolimus, in two concentrations 0,03% and 0,1%, is competent to obtain relief of pain, even if the first one does not warrant a complete healing, whereas its cessation determines recurrences within 1 or 2 weeks [13].…”

Section: Calcineurin Inhibitors (Cyclosporina Pimecrolimus Tacrolimus)mentioning

confidence: 99%

Topical Therapies for Oral Lichen Planus Management and their Efficacy: A Narrative Review

Bagán

Compilato²,

Paderni³

et al. 2012

CPD

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Oral Lichen Planus (OLP) is a chronic inflammatory condition implicating T cell-mediated cytotoxicity, and involving oral mucosal surfaces. Several therapeutic regimens have been evaluated to treat OLP and pain related, but often without high level of evidence. Topical formulations are the favourite for the majority of cases; bioadhesive formulations have been considered very useful and practical for local drug delivery in oral mucosa, due to the increased residence time on the oral mucosa of the dosage forms and better therapeutic efficacy.In this narrative review, authors try to illustrate the current topical managements for OLP from the accessible literature on this topic. Steroids are very helpful in discomfort and making better quality of life: they are considered the first-line treatment even if they could cause secondary candidosis, and sometimes bad taste, nausea, dry mouth, sore throat or swollen mouth.Other substances or devices by topical administration are adopted especially when the first line approach is refractory. This is the case when retinol with its synthetic and natural analogues (retinoids), hyaluronic acid, or Aloe Vera are chosen.Recent topical applications for OLP therapy include phototherapy and low/high energy pulsing light; the treatment with extracorporeal photochemotherapy is also reasonable and promising.Finally, calcineurin inhibitors (i.e. cyclosporine, tacrolimus and pimecrolimus), antioxidant and biologics (i.e alefacept, efalizumab, basiliximab, TNF-inhibitors -infliximab, rituximab) may be alternative approaches when OLP does not respond to the standard protocols.In this scenario, there are several studies on molecules different from glucocorticosteroids, but not sufficient or statistically adequate to justify their evidence-based use in OLP; large randomized placebo controlled trials are required to evaluate the safety and effectiveness of these non conventional therapies.In conclusion, since OLP is a chronic disease and requires long-term management, the dental/medical practitioner, who treats OLP patients, needs to know the natural history of OLP, how to monitor, and how to treat, taking in account all of the available modalities conventional and not, with pros and cons.

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“…Reports of treatments for oral lichen planus in the literature include topical modalities, 13 such as cyclosporin swish and spit, 10 corticosteroids, 4,22 retinoids, 12 and tacrolimus, 14 and systemic modalities, such as dapsone, hydroxychloroquine, 11 mycophenolate mofetil, 15 thalidomide, 6 and enoxaparin, 16 but randomized control trials comprise only a limited number of these reports. 23 Efalizumab is a recombinant humanized monoclonal IgG1 antibody that binds to CD11a, the ␣ subunit of LFA-1 (lymphocyte function-associated antigen 1).…”

Section: Commentmentioning

confidence: 99%