Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2002 Jul;46(7):2238-43.
doi: 10.1128/AAC.46.7.2238-2243.2002.

Acyclovir cream for treatment of herpes simplex labialis: results of two randomized, double-blind, vehicle-controlled, multicenter clinical trials

Affiliations
Clinical Trial

Acyclovir cream for treatment of herpes simplex labialis: results of two randomized, double-blind, vehicle-controlled, multicenter clinical trials

Spotswood L Spruance et al. Antimicrob Agents Chemother. 2002 Jul.

Abstract

Acyclovir cream has been available for the treatment of herpes labialis in numerous countries outside the United States for over a decade. Evidence for its efficacy comes from a few small clinical trials conducted in the 1980s. To examine more comprehensively the efficacy and safety of this formulation, we conducted two independent, identical, parallel, randomized, double-blind, vehicle-controlled, large-scale multicenter clinical trials. Healthy adults with a history of frequent herpes labialis were recruited from the general population, screened for eligibility, randomized equally to 5% acyclovir cream or vehicle control, given study medication, and told to self-initiate treatment five times daily for 4 days beginning within 1 h of the onset of a recurrent episode. The number of patients who treated a lesion was 686 in study 1 and 699 in study 2. In study 1, the mean duration of episodes was 4.3 days for patients treated with acyclovir cream and 4.8 days for those treated with the vehicle control (hazards ratio [HR] = 1.23; 95% confidence interval [CI], 1.06 to 1.44; P = 0.007). In study 2, the mean duration of episodes was 4.6 days for patients treated with acyclovir cream and 5.2 days for those treated with the vehicle control (HR = 1.24; 95% CI, 1.06 to 1.44; P = 0.006). Efficacy was apparent whether therapy was initiated "early" (prodrome or erythema lesion stage) or "late" (papule or vesicle stage). There was a statistically significant reduction in the duration of lesion pain in both studies. Acyclovir cream did not prevent the development of classical lesions (progression to vesicles, ulcers, and/or crusts). Adverse events were mild and infrequent.

PubMed Disclaimer

Figures

FIG. 1.
FIG. 1.
Randomization and disposition of patients in study 1.
FIG. 2.
FIG. 2.
Randomization and disposition of patients in study 2.
FIG. 3.
FIG. 3.
Kaplan-Meier survival curves of clinician-assessed duration of herpes labialis episode for study 1 (A) and study 2 (B).
FIG. 4.
FIG. 4.
Kaplan-Meier survival curves of patient-assessed duration of pain for study 1 (A) and study 2 (B).

Similar articles

Cited by

References

    1. Fiddian, A. P., and L. Ivanyi. 1983. Topical acyclovir in the management of recurrent herpes labialis. Br. J. Dermatol. 109:321-326. - PubMed
    1. Fiddian, A. P., J. M. Yeo, R. Stubbings, and D. Dean. 1983. Successful treatment of herpes labialis with topical acyclovir. Br. Med. J. 286:1699-1701. - PMC - PubMed
    1. Freeman, D. J., N. V. Sheth, and S. L. Spruance. 1986. Failure of topical acyclovir (ACV) in ointment to penetrate human skin. Antimicrob. Agents Chemother. 29:730-732. - PMC - PubMed
    1. Green, J. A., S. L. Spruance, G. Wenerstrom, and M. W. Piepkorn. 1985. Post-herpetic erythema multiforme prevented with prophylactic oral acyclovir. Ann. Intern. Med. 102:632-633. - PubMed
    1. Harris, E. K., and A. Albert. 1991. Survivorship analysis for clinical studies. Marcel Dekker, New York, N.Y.

Publication types