Valacyclovir and topical clobetasol gel for the episodic treatment of herpes labialis: a patient-initiated, double-blind, placebo-controlled pilot trial


  • Clinical Trials registration: NCT00297011

Correspondence: C Hull. E-mail:



Background  Treatment of herpes simplex labialis (HSL) has been associated with modest benefits. This difficulty results from the rapid resolution of the disease accomplished by the immune system, which narrows the window of therapeutic opportunity. The immune response is also responsible for important clinical manifestations, including oedema and pain. The dual role of immune responses (protection, pathology) is well recognized in other infectious diseases. The addition of corticosteroids to antimicrobial agents has been associated with improvement in some of these diseases.

Objective  We evaluated the combination of oral valacyclovir plus topical clobetasol compared to placebo for recurrent HSL.

Methods  Eighty-one subjects were screened, randomized, and dispensed medication (valacyclovir 2 g orally twice daily φορ 1 day and clobetasol gel 0.05% twice daily for 3 days). Forty-two patients developed a recurrence and initiated treatment.

Results  There were more aborted lesions in the valacyclovir–clobetasol arm compared to placebo–placebo (50% vs.15.8%, P = 0.04). Combination therapy reduced the mean maximum lesion size (9.7 vs. 54 mm2, P = 0.002) and the mean healing time of classical lesions (5.8 vs. 9.3 days, P = 0.002). We created a composite statistic, area-under-the-curve (AUC) of classical lesion size versus time. There was a reduction in the AUC in the combination arm compared with placebo (23 vs. 193 mm2, P < 0.001). Adverse events were minimal. Secondary and post-treatment recurrences were not increased by combination therapy.

Conclusions  This pilot study supports the addition of topical corticosteroids to an oral antiviral agent for the treatment of HSL. Larger studies need to confirm the safety and efficacy of this approach.

Conflicts of interest

Dr Hull has served as a consultant for GlaxoSmithKline