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Topical clobetasol in the treatment of atrophic-erosive oral lichen planus: a randomized controlled trial to compare two preparations with different concentrations.

Abstract
Oral lichen planus (OLP) is a chronic inflammatory disease that can be painful, mainly in the atrophic and erosive forms. Numerous drugs have been used with dissimilar results, but most treatments are empirical and do not have adequate control groups or correct study designs. However, to date, the most commonly employed and useful agents for the treatment of LP are topical corticosteroids. A randomized, double-blind, placebo-controlled trial has been designed to compare the efficacy and safety of two different formulations of clobetasol, a very potent topical steroid, in the topical management of OLP and to evaluate which gives the longest remission from signs and symptoms. Thirty-five consecutive patients were divided into two groups: the first received clobetasol propionate 0.025% and the second was given clobetasol propionate 0.05%. Both drugs were placed in 4% hydroxyethyl cellulose bioadhesive gel. Anti-mycotic prophylaxis was also added. After the end of therapy, patients received a 2-month follow-up. In all, 14 of the 15 clobetasol 0.025% patients (93%) and 13 of the 15 clobetasol 0.05% patients (87%), had symptoms improvement after 2 months of therapy (P = 0.001 in both groups). Also, 13 of the 15 clobetasol 0.025% patients (87%) and 11 of the 15 clobetasol 0.05% patients (73%) had clinical improvement after 2 months of therapy (P < 0.05 in both groups). No statistical differences were found in comparing the two different formulations. A larger concentration of the active molecules cannot further improve the therapeutic findings or optimize the obtained results in a significant manner.
AuthorsM Carbone, P G Arduino, M Carrozzo, G Caiazzo, R Broccoletti, D Conrotto, C Bezzo, S Gandolfo
JournalJournal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology (J Oral Pathol Med) Vol. 38 Issue 2 Pg. 227-33 (Feb 2009) ISSN: 1600-0714 [Electronic] Denmark
PMID19141065 (Publication Type: Journal Article, Randomized Controlled Trial)
Chemical References
  • Gels
  • Glucocorticoids
  • Clobetasol
Topics
  • Administration, Topical
  • Aged
  • Aged, 80 and over
  • Clobetasol (administration & dosage)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Gels
  • Glucocorticoids (administration & dosage)
  • Humans
  • Lichen Planus, Oral (drug therapy, pathology)
  • Male
  • Middle Aged
  • Pain Measurement

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