Randomized, placebo-controlled, double-blind trial of clobetasol propionate 0.05% in the treatment of oral lichen planus

Abstract

Objective: To perform a randomized, placebo-controlled, double-blind study, with a follow-up period of 6 months, for the use of topical clobetasol in cases of symptomatic oral lichen planus (OLP).

Subjects and methods: Thirty-two participants were analyzed, with the aims of: (I) to compare the usefulness of topically applied clobetasol propionate 0.05% (mixed with 4% hydroxyethyl cellulose gel) and 4% hydroxyethyl cellulose gel alone (considered as placebo) in the management of OLP; (II) to describe which of them is quicker in decreasing signs and reported symptoms, and (III) which is able to give the proper longer remission in the follow-up.

Results: Symptoms improved in all clobetasol-treated patients during the first 2 months of therapy, while only 50% of placebo control group (p = .005) displayed similar results; of the remaining half, 12.5% did experienced a worsening while 37.5% remained stable. Regarding clinical signs, 87.5% of clobetasol-treated patients improved, while only 62.5% of the placebo-treated patients had a positive response (p = .229).

Conclusions: It is possible to report that clobetasol, at this dosage, has been more effective than a placebo at provoking symptoms improvement in subjects affected by atrophic-erosive oral lesions.

Keywords: clobetasol; oral lichen planus; outcome; placebo; symptomatic.