Safety, Pharmacokinetics, and Efficacy Study of NB-001 to Treat Recurrent Herpes Labialis

Purpose of this study is to determine the safety and efficacy of topical applications of NB-001 as compared to placebo for the treatment of recurrent herpes labialis.

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Key information

Conditions

Herpes Labialis DNA Virus Infections Herpes Simplex Herpesviridae Infections Infections Lip Diseases Mouth Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Stomatognathic Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Affiliated Research Center, Inc., Huntsville, Alabama, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 to 80 years of age of either gender
Good general health
History of recurrent herpes labialis with at least 3 episodes per year

Exclusion criteria

Pregnant and/or nursing female
Lesions or irritation on or around the lips that would interfere with recognition of a herpes labialis attack
Treatment with topical steroids, antivirals, or new topical products on or around the lips in the week prior to the onset of an attack
Known allergies to topical creams, ointments or medications.

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

NB-001

Drug

Primary outcomes

Time to healing as assessed by the subject.

Secondary outcomes

Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.

Sponsors and collaborators

Lead sponsor

NanoBio Corporation

Industry

Registry information

Official study title

The Safety, Pharmacokinetics, and Efficacy of NB-001 (0.1%, 0.3%, 0.5%) in Subjects With Recurrent Herpes Labialis

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Mar 28, 2007
Registry last updated: May 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed