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.