NCT02207881

A Double-Blind, Randomized, Placebo-Controlled Study of Topical VDO for the Treatment of Herpes Simplex Labialis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Yung Shin Pharm. Ind. Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Recurrent herpes labialis are usually a minor malady of limited duration, although they are often painful and are uniformly discomforting for patients. Oral antivirals represent an advance in the treatment of recurrent herpes labialis, but the clinical implications are modest. Randomized, controlled clinical trials have shown that oral antivirals decrease the duration of lesion episodes and pain by approximately one day. In recurrent HSV infections including herpes labialis, many instances of viral re-activation occur without symptoms, and can only be identified by detection of virus on the lips of infected individuals. In these cases, the virus is cleared from the local site without the development of a classical ulcerative herpes lesion. In the other cases, the triggered specific immune response rapidly stops viral replication in the skin and also causes the development of the herpes lesion prodrome and a considerable part of the symptoms associated with a classical ulcerative herpes lesion. One could therefore predict that treatment with an antiviral drug alone would help the immune system in shortening the virus replication, but may not substantially reduce the disfiguring symptoms caused by the immune reaction. In dermatology, the principle of using an anti-inflammatory drug improve clinical outcomes by reducing inflammation-related symptoms associated with the infection has been well established. We have found that a topical formulation of VDO is useful for alleviating pain and inflammation associated with infection caused by herpes virus.

Detailed description

In the treatment of oral herpes labialis, it is desirable to have local absorption of the drug to provide pain relief directly at the lesion sites while minimizing overall exposure. The present study is designed to elucidate the effects of VDO ( on recurrent herpes simplex labialis.

Conditions

• Herpes Labialis

Interventions

Type	Name	Description
DRUG	VDO gel	VDO gel
DRUG	placebo	matching placebo gel

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-08-04
• Last updated: 2016-04-15

Locations

1 site across 1 country: Taiwan