Clinical Trials registration: NCT00297011
Valacyclovir and topical clobetasol gel for the episodic treatment of herpes labialis: a patient-initiated, double-blind, placebo-controlled pilot trial
Article first published online: 9 JAN 2009
© 2009 The Authors. Journal compilation © 2009 European Academy of Dermatology and Venereology
Journal of the European Academy of Dermatology and Venereology
Volume 23, Issue 3, pages 263–267, March 2009
How to Cite
Hull, C., McKeough, M., Sebastian, K., Kriesel, J. and Spruance, S. (2009), Valacyclovir and topical clobetasol gel for the episodic treatment of herpes labialis: a patient-initiated, double-blind, placebo-controlled pilot trial. Journal of the European Academy of Dermatology and Venereology, 23: 263–267. doi: 10.1111/j.1468-3083.2008.03047.x
- Issue published online: 9 FEB 2009
- Article first published online: 9 JAN 2009
- Received: 29 May 2008; Accepted 2 July 2008
- clobetasol gel;
- herpes simplex labialis;
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