MedTrace Logo

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

NCT02207881 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-04-15

No results posted yet for this study

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.

Conditions

  • Herpes Labialis

Interventions

DRUG

VDO gel

VDO gel

DRUG

placebo

matching placebo gel

Sponsors & Collaborators

  • Changhua Christian Hospital

    collaborator OTHER

  • Yung Shin Pharm. Ind. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • HUNG-MING WU, MD, PhD · Changhua Christian Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02207881 on ClinicalTrials.gov