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Topical corticosteroids in association with miconazole and chlorhexidine in the long-term management of atrophic-erosive oral lichen planus: a placebo-controlled and comparative study between clobetasol and fluocinonide.

Author(s): Carbone M, Conrotto D, Carrozzo M, Broccoletti R, Gandolfo S, Scully C

Affiliation(s): Department of Oral Medicine, School of Medicine and Dentistry, University of Turin, Italy.

Publication date & source: 1999-01, Oral Dis., 5(1):44-9.

Publication type: Clinical Trial; Randomized Controlled Trial

OBJECTIVE: To evaluate the efficacy of a combination of topical corticosteroids with topical antimycotic drugs in the therapy of atrophic-erosive forms of oral lichen planus (OLP). PATIENTS AND METHODS: The study population consisted of 60 patients with OLP subdivided into three groups matched for sex and age. The first group (25 patients) and the second group (24 patients) received respectively 0.05% clobetasol propionate ointment or 0.05% fluocinonide ointment in an adhesive medium (4% hydroxyethyl cellulose gel) plus in each case antimycotic treatment consisting of miconazole gel and 0.12% chlorhexidine mouthwashes. The third group (11 patients), placebo group, received only hydroxyethyl cellulose gel and antimycotic treatment as above. All the treatment regimens were carried out for 6 months. Each patient was examined every 2 months during the 6-month period of active treatment and for a further 6 months of follow-up. Objective and subjective clinical progress was scored and compared between the three groups. Plasma cortisol levels were monitored in half the patients using the topical corticosteroids. RESULTS: All patients treated with clobetasol and 90% of the patients treated with fluocinonide witnessed some improvement, whereas in the placebo group only 20% of patients improved (P < 0.0001 and P = 0.00029, respectively. However, when considering complete responses, only clobetasol gave significantly better results than placebo. Clobetasol resolved 75% of the lesions whereas fluocinonide was effective in 25% of cases and placebo in none. Clobetasol achieved better results statistically than did fluocinonide (P = 0.00442) and placebo (P = 0.00049) whereas there was no statistical difference among fluocinonide and placebo (P = 0.140). Similar results were obtained for symptoms. Both drugs were shown to be effective in the treatment of erosive lesions, but clobetasol was considerably more efficacious than fluocinonide in the atrophic areas (75% vs 25% of total response, respectively) (P = 0.00442). None of the treated patients contracted oropharyngeal candidiasis. After 6 months of follow-up, 65% of the clobetasol-treated group and 55% of the fluocinonide group were stable. Estimation of plasma cortisol levels showed no significant systemic adverse effects of clobetasol or fluocinonide. CONCLUSIONS: Our results suggest that a very potent topical corticosteroid such as clobetasol may control OLP in most cases, with no significant adrenal suppression or adverse effects. Moreover, a concomitant antimycotic treatment with miconazole gel and chlorhexidine mouthwashes is a useful and safe prophylaxis against oropharyngeal candidiasis.

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