Clinical efficacy of topical docosanol 10% cream for herpes simplex labialis: A multicenter, randomized, placebo-controlled trial

Sacks, Stephen L.; Thisted, Ronald A.; Jones, Terry M.; Barbarash, Rick A.; Mikolich, Dennis J.; Ruoff, Gary; Jorizzo, Joseph L.; Gunnilla, Lucy B.; Katz, David H.; Khalil, Mohammed; Morrow, Phillip R.; Yakatan, Gerald J.; Pope, L. S.; Berga, James E.

doi:10.1067/mjd.2001.116215

Cited by 80 publications

(49 citation statements)

References 19 publications

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“…The polysaccharides (30), anthraquinones (39), triterpenes (38), phloroglucinol (2), flavonoids (26), and catechin derivatives (12) isolated from medicinal plants have been found to have inhibitory activities against the replication of HSV-1. There has been a promising result for a naturally occurring antiherpetic agent, n-docosanol, which has recently completed extensive clinical evaluation and been approved by the U.S. Food and Drug Administration as a topical treatment for herpes labialis (1,34,36). These findings show that natural products are still potential sources in the search for new antiherpetic agents.…”

mentioning

confidence: 88%

Samarangenin B from Limonium sinense Suppresses Herpes Simplex Virus Type 1 Replication in Vero Cells by Regulation of Viral Macromolecular Synthesis

Kuo

Lin

Tsai

et al. 2002

Antimicrob Agents Chemother

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mentioning

confidence: 88%

Samarangenin B from Limonium sinense Suppresses Herpes Simplex Virus Type 1 Replication in Vero Cells by Regulation of Viral Macromolecular Synthesis

Kuo

Lin

Tsai

et al. 2002

Antimicrob Agents Chemother

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“…It is presumed, but not proven, that a strong antiviral effect hastens wound resolution by decreasing the extent of keratinocyte destruction, the viral antigen load, and the attendant inflammatory response, which impair reepithelization at the site of infection (1,9,11,22). One-day, two-dose oral valacyclovir constitutes a convenient treatment for herpes labialis in comparison to topical therapies, which typically require frequent applications for multiple days (13,15,19,20,23). While direct comparisons between oral and topical therapy have not been conducted, the available data suggest that oral therapy is more effective.…”

Section: Discussionmentioning

confidence: 99%

“…Until now, most treatments have consisted of creams that must be applied to affected areas multiple times a day for several days (6,13,15,19,20,23). There have been two previous clinical trials of oral antiviral therapy for episodic treatment of herpes labialis.…”

mentioning

confidence: 99%

“…The infection is most often acquired in childhood, but the incidence increases with age (2, 5, 12, 18). Up to 90% of persons over the age of 50, depending on race, sex, and country, would test seropositive for HSV-1, and an estimated 20 to 40% of adults experience cold sore outbreaks (5,12,18,25).Until now, most treatments have consisted of creams that must be applied to affected areas multiple times a day for several days (6,13,15,19,20,23). There have been two previous clinical trials of oral antiviral therapy for episodic treatment of herpes labialis.…”

mentioning

confidence: 99%

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High-Dose, Short-Duration, Early Valacyclovir Therapy for Episodic Treatment of Cold Sores: Results of Two Randomized, Placebo-Controlled, Multicenter Studies

Spruance

Jones

Blatter

et al. 2003

Antimicrob Agents Chemother

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102

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Oral valacyclovir is better absorbed than oral acyclovir, increasing acyclovir bioavailability three-to fivefold. This provides the opportunity to explore whether high systemic acyclovir concentrations are effective in the treatment of cold sores (herpes labialis). Two randomized, double-blind, placebo-controlled studies were conducted. Subjects were provided with 2 g of valacyclovir twice daily for 1 day (1-day treatment), 2 g of valacyclovir twice daily for 1 day and then 1 g of valacyclovir twice daily for 1 day (2-day treatment), or a matching placebo and instructed to initiate treatment upon the first symptoms of a cold sore. In study 1, the median duration of the episode (primary endpoint) was reduced by 1.0 day (P ‫؍‬ 0.001) with 1-day treatment and 0.5 days (P ‫؍‬ 0.009) with 2-day treatment compared to placebo. Similarly, the mean duration of the episode was statistically significantly reduced by 1.1 days with 1-day treatment and 0.7 days with 2-day treatment compared to placebo. The proportion of subjects in whom cold sore lesion development was prevented and/or blocked was increased by 6.4% (P ‫؍‬ 0.096) with 1-day treatment and 8.5% (P ‫؍‬ 0.061) with 2-day treatment compared to placebo. The time to lesion healing and time to cessation of pain and/or discomfort were statistically significantly reduced with valacyclovir compared to placebo. In study 2, results similar to those in study 1 were obtained. AEs were similar across treatment groups. These studies provide evidence supporting a simple, 1-day valacyclovir treatment regimen for cold sores that is safe and effective. The 1-day valacyclovir regimen offers patients a unique and convenient dosing alternative compared to available topical therapies.Herpes labialis, or cold sores, are caused by herpes simplex virus type 1 (HSV-1) and can result in significant irritation, pain, discomfort, and worry (18,25). The infection is most often acquired in childhood, but the incidence increases with age (2, 5, 12, 18). Up to 90% of persons over the age of 50, depending on race, sex, and country, would test seropositive for HSV-1, and an estimated 20 to 40% of adults experience cold sore outbreaks (5,12,18,25).Until now, most treatments have consisted of creams that must be applied to affected areas multiple times a day for several days (6,13,15,19,20,23). There have been two previous clinical trials of oral antiviral therapy for episodic treatment of herpes labialis. In a double-blind, placebo-controlled trial involving 210 subjects with recurrent cold sores, it appeared that less time was required for the loss of hard crust for subjects taking 200 mg of oral acyclovir 5 times daily for 5 days (14). This difference as well as other measures of clinical healing was not statistically significant. Spruance et al. evaluated a regimen of 400 mg of oral acyclovir 5 times daily for 5 days in comparison with placebo (21). Overall in this study, acyclovir did not affect the duration of the episode, mean maximum lesion size, or the development of lesions, but a subset o...

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“…3% foscarnet cream can be recommended if lesions are known to be acyclovir-resistant and it reduces HSV shedding, resulting in more aborted lesions, reduction in lesion size and duration. [54,55] …”

Section: Tetracyclinesmentioning

confidence: 99%

Topical drug delivery: An essential aid in the management of oral diseases

Shastry¹,

Sanjay²,

Kaul³

et al. 2015

JCRI

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Topical medications play an important role in the management of oral lesions. Various topical medications ranging from topical anesthetics to topical antineoplastics have been widely used in dentistry. Topical medications have been extensively used as the first line of therapy in many conditions such as vesiculobullous diseases, oral infections like candidiasis, herpes simplex, potentially malignant disorders, neuropathic pain, and oral mucositis. Topical drug therapy provides targeted and a more efficient drug delivery options for the local oral lesions as compared to systemic therapy. While accessibility, lower systemic side effects, and many other advantages are associated with the usage of topical oral medications, several challenges are also faced such as taste alterations, poor penetration, and limited surface area. The objective of this review is to provide insight into the mechanism of topical drug delivery, summary of various topical medications used in oral lesions, advantages and disadvantages, characteristic of oral mucosa and various challenges faced in delivering topical medications.

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Clinical efficacy of topical docosanol 10% cream for herpes simplex labialis: A multicenter, randomized, placebo-controlled trial

Cited by 80 publications

References 19 publications

Samarangenin B from Limonium sinense Suppresses Herpes Simplex Virus Type 1 Replication in Vero Cells by Regulation of Viral Macromolecular Synthesis

Samarangenin B from Limonium sinense Suppresses Herpes Simplex Virus Type 1 Replication in Vero Cells by Regulation of Viral Macromolecular Synthesis

High-Dose, Short-Duration, Early Valacyclovir Therapy for Episodic Treatment of Cold Sores: Results of Two Randomized, Placebo-Controlled, Multicenter Studies

Topical drug delivery: An essential aid in the management of oral diseases

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