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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00453401

Enrollment

1000

Registered

2007-03-28

Start date

2007-02-28

Completion date

2007-12-31

Last updated

2008-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Labialis

Keywords

cold sore

Brief summary

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.

Interventions

DRUGNB-001

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	Time frame
Time to healing as assessed by the subject.	—

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026