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

Abstract

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...

Combined topical dexamethasone/tacrolimus therapy for management of oral chronic GVHD

“…28 In the second case, increased TAC plasma level was measured in a 6-year-old patient (8.6 ng/ ml) after erroneous over-dosage with topical TAC ointment. 14 Corrocher et al 31 reported undetectable serum TAC level (o1.5 ng/ml) in 11 patients treated with 0.1% ointment for desquamative gingivitis after 4 weeks of treatment. Our data demonstrated minimal evidence of systemic TAC absorption; however, larger prospective studies are needed.…”

Calcineurin inhibitors in oral medicine

“…23 Topical tacrolimus has also been reported to be effective in the management of oral mucosal lesions of GvHD, 24-26 MMP, [27][28][29] pemphigus vulgaris of the lip, 30 and the oral ulceration and labial enlargement of OFG and oral Crohn disease. 31,32 Oral lichen planus.…”

Use of Fusidic Acid for Desquamative Gingivitis Treatment: 1-Year Follow-Up

“…To the best of the authors' knowledge there is only one clinical trial using topical therapy in patients with DG, but the patients were followed up for 6 weeks only (7). Nevertheless the response to topical therapies of desquamative oral lesions in gingiva is frequently favorable in short time evaluations, lacking reliability in a longer term.…”

“…Patients present periods of remission and exacerbation, and it might heal after several months or the condition persists for years. Therefore, some authors treat DG lesions with topical corticosteroids when the systemic related disease is under control and in cases of extraoral lesions, systemic steroids are the main choice (7). Nevertheless, the lack of adherence of the topical drug to the affected sites for a long time may reduce efficacy of the treatment (5,8).…”