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=0.005) displayed similar results; of the remaining half, 12.5% did experienced a worsening whilst 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=0.229).

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.

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