Herpes labialis treatment with acyclovir 5% modified aqueous cream: A double-blind, randomized trial

Raborn, G. Wayne; McGaw, William T.; Grace, Michael; Percy, J. S.; Samuels, Sheri M.

doi:10.1016/0030-4220(89)90007-8

Cited by 64 publications

(28 citation statements)

References 17 publications

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“…These results unequivocally establish the efficacy of ACV cream on this disease, which previously had been examined in small-scale trials (2,7,9,21). In study 1, the episode duration was reduced by 0.5 days (10%; P ϭ 0.007), and in study 2, episode duration was reduced by 0.6 days (12%; P ϭ 0.006).…”

Section: Discussionsupporting

confidence: 71%

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Acyclovir Cream for Treatment of Herpes Simplex Labialis: Results of Two Randomized, Double-Blind, Vehicle-Controlled, Multicenter Clinical Trials

Spruance

Nett

Marbury

et al. 2002

Antimicrob Agents Chemother

122

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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.Acyclovir (ACV) has been found to be efficacious in the management of herpes labialis in a variety of formulations and routes of administration. ACV (5%) ointment (Zovirax ointment) accelerated healing of herpes labialis in immunocompromised patients (22). Peroral administration of 400 mg of ACV five times/day for 5 days significantly reduced virus shedding and reduced lesion healing time and the duration of lesion pain among the subgroup of patients who started treatment "early" (in the prodrome or erythema lesion stage) (19). Peroral ACV administered as prophylaxis at 400 mg two times/day significantly reduces the frequency of recurrent episodes and prevents herpes-associated erythema multiforme (4,8,11).Demonstration of the clinical efficacy of topical formulations of antiviral drugs among immunocompetent patients has been difficult because of the marked variance in lesion severity that occurs, necessitating large numbers of subjects; the rapid natural healing of lesions; and the difficulty in finding a topical drug formulation that facilitates skin penetration without causing undue skin irritation (15,16,20). Several studies with ACV ointment in immunocompetent subjects provided sparse evidence of efficacy in this population (1,6,13,17). ACV was shown to penetrate human skin more effectively in a cream than in an ointment formulation (3). According...

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Section: Discussionsupporting

confidence: 71%

“…ACV was shown to penetrate human skin more effectively in a cream than in an ointment formulation (3). Accordingly, data supporting the efficacy of ACV cream have been more readily obtained, sufficient to support licensure in European countries, even though the sizes of the studies were small (2,7,21) and one negative report has been published (9).…”

mentioning

confidence: 99%

Acyclovir Cream for Treatment of Herpes Simplex Labialis: Results of Two Randomized, Double-Blind, Vehicle-Controlled, Multicenter Clinical Trials

Spruance

Nett

Marbury

et al. 2002

Antimicrob Agents Chemother

122

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“…Multiple trials have shown that these drugs reduce HSL lesion healing time, and there is limited evidence that other aspects of HSL are improved. [5][6][7][8][9][10] Although the immune response limits the severity of recurrent HSL lesions, it probably contributes to many of the symptoms. There is evidence supporting a role of the inflammatory response in the pathogenesis of HSL lesions.…”

Section: Discussionmentioning

confidence: 99%

“…These have been primarily a reduction in lesion healing time. [4][5][6][7][8][9] The pathogenesis of an HSL lesion involves both the destruction of cells by the virus and the host immune response. The adaptive immune response contributes to rapid control of recurrent HSL disease but may also be responsible for many of the clinical signs and symptoms that can persist for up to a week or longer, even after the virus can no longer be isolated.…”

mentioning

confidence: 99%

Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: A randomized, double-blind, placebo-controlled, patient-initiated clinical trial

Hull

Harmenberg

Arlander

et al. 2011

Journal of the American Academy of Dermatology

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“…The cream form has to be applied 5 times daily for up to 7 days from the prodromal phase of the disease to reduce time to healing and duration of pain [20]. Yet, several studies failed to prove the efficacy of acyclovir cream in the active and late phases of HSV infections [21,22].…”

Section: Efficacymentioning

confidence: 99%

Penciclovir Cream – Improved Topical Treatment for Herpes simplex Infections

Schmid‐Wendtner

Korting

2004

Skin Pharmacol Physiol

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Human herpesviruses can be found worldwide and cause many viral infections in immunocompetent as well as in immunocompromised patients. Herpes simplex virus (HSV) diseases can be the cause of life-threatening disease, especially in neonates. After initial infection, HSV persists latently in host neurons with the risk of periodical reactivation over a lifetime. The development of acyclovir, a potent and specific nucleoside inhibitor of the herpes DNA polymerase, was a milestone in the history of antiviral drugs in the late 1970s. During the last decades a better understanding of the replication and disease-causing state of HSV types 1 and 2 has been achieved enabling the development of new and potent antiviral compounds. In the mid-1990s, for example, valacyclovir and famciclovir were launched as prodrugs of acyclovir with improved bioavailability. Despite the numerous drugs available for the systemic treatment of HSV infections, the topical application of a cream containing an antiviral agent is still the most convenient method of treating herpes simplex labialis/facialis in the general population. For some time, the topical standard treatment for recurrent HSV infections has been acyclovir cream, despite the fact that the evidence for efficacy in recurrent episodes has been equivocal. Penciclovir, a novel acyclic nucleoside analogue, has demonstrated efficacy against HSV types 1 and 2 and seems to have a pharmacological advantage due to a prolonged half-life of its active form in HSV-infected cells. This review discusses and compares the topical treatment modalities available for HSV infections. As a conclusion, different studies are available that have shown that it is possible to reduce viral replication and hasten lesion resolution with 1% penciclovir treatment beyond the prodromal phase of the HSV infection. Comparing data of topical treatment with acyclovir and penciclovir revealed a superiority for penciclovir cream showing a significant decrease in time to lesion healing, lesion area and pain. While systemic acyclovir or valacyclovir may be valid drugs especially for HSV prophylaxis, 1% penciclovir cream should be preferred as topical treatment since there are good therapeutic results independent of the phase of development of herpetic eruptions.

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Herpes labialis treatment with acyclovir 5% modified aqueous cream: A double-blind, randomized trial

Cited by 64 publications

References 17 publications

Acyclovir Cream for Treatment of Herpes Simplex Labialis: Results of Two Randomized, Double-Blind, Vehicle-Controlled, Multicenter Clinical Trials

Acyclovir Cream for Treatment of Herpes Simplex Labialis: Results of Two Randomized, Double-Blind, Vehicle-Controlled, Multicenter Clinical Trials

Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: A randomized, double-blind, placebo-controlled, patient-initiated clinical trial

Penciclovir Cream – Improved Topical Treatment for Herpes simplex Infections

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