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

NanoBio Corporation

Status and phase

Completed

Phase 2

Conditions

Herpes Labialis

Treatments

Drug: NB-001

Study type

Interventional

Funder types

Industry

Identifiers

NCT00453401

NB-001-003

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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