NB-001 Treatment of Recurrent Herpes Labialis

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 Treatment of Recurrent Herpes Labialis

This is a study to test the hypothesis that time to healing of a cold sore will be lower in the active treatment arm of the study when compared to the vehicle (placebo). Subjects with a history of cold sores will be enrolled and administered active treatment or placebo in a blinded manner. Subjects will then be followed to assess time to healing.

Study Overview

• Status: Unknown
• Conditions: Herpes Labialis
• Intervention / Treatment: Drug: Placebo; Drug: NB-001 (0.3%)

• Study Type: Interventional
• Enrollment (Actual): 362
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Radiant Research, Inc
    • Tucson, Arizona, United States, 85710
      • Radiant Research, Inc
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Radiant Research, Inc. Chicago
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Central Kentucky Research Associates, Inc.
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Radiant Research, Inc.
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research, P.C.
    • St. Louis, Missouri, United States, 63141
      • Radiant Research, Inc.
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research, Inc.
    • Mt. Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • Texas
    • Dallas, Texas, United States, 75234
      • Research Across America
    • San Antonio, Texas, United States, 78229
      • Radiant Research, Inc.
  • Virginia
    • Christiansburg, Virginia, United States, 24073
      • New River Valley Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Be a healthy man or woman 18 years of age or older. Women who are pregnant, lactating or may become pregnant may (at the investigator's discretion) be included in the study;
2. Have recurrent herpes labialis as defined by a history of three (3) or more cold sore recurrences on the lips and/or skin surrounding the lips in the previous year. The majority of their cold sore recurrences proceeded by a well-defined history of prodromal symptoms including redness, pain, burning, tingling, itching, swelling or a tight sensation of the lip at the site of the outbreak;
3. Be willing to refrain from using systemic or topical antiviral agents or systemic corticosteroids within 4 weeks prior to study drug administration and for the duration of the cold sore recurrence;
4. Be willing to refrain from using any topical pharmaceutical or cosmetic products other than the study medication in or around the nasal and perioral areas for the duration of the cold sore recurrence;
5. Be willing to refrain from participation in another clinical trial;
6. Be willing and able to use phone or internet to obtain the combination to unlock their study medication kit;
7. Be able to read and write in English and understand and comply with the protocol requirements;
8. Be able to give informed consent and have signed a written informed consent form.

Exclusion Criteria:

1. Known hypersensitivity to one of the drug ingredients, including soybean oil, polysorbate (Tween), alcohol, EDTA, or cetylpyridinium chloride (found in some mouthwashes and lozenges);
2. Severe chronic illness including renal failure, severe respiratory or cardiac disease, chronic infections, immunodeficiency syndrome, uncontrolled diabetes mellitus or untreated severe thyroid disease;
3. Received (within the last 6 months) or receiving chemotherapy;
4. Significant skin disease on the face (such as atopic dermatitis, cystic acne, severe rosacea, eczema, psoriasis or other chronic vesiculobullous disorders) or lesions, wounds, abrasions, piercings, tattoos, irritation or other skin conditions on or around the nasal and perioral areas that would interfere with the treatment or assessment of the primary lesion complex. Subjects with mild controlled psoriasis, eczema, acne or dermatitis or other conditions may be included if the condition does not interfere with the ability to evaluate a herpes labialis lesion or local skin irritation;
5. Previously received herpes vaccine;
6. Active alcohol or drug abuse;
7. Prior randomization into any NanoBio study;
8. Any condition that would potentially make them unable to participate for the entire trial period;
9. Known allergies to topical creams, ointments or other topical medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NB-001 (0.3%); NB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and two surfactants: polysorbate (Tween) 20 and cetylpyridinium chloride (CPC).	Drug: NB-001 (0.3%); Topical administration at least five times throughout the day
PLACEBO_COMPARATOR: Vehicle; NB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and one surfactant: polysorbate (Tween) 20.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator.	Time to healing is the time from receiving the combination to unlock the medication and begin treatment to investigator assessed healing.	Time to healing will be assessed from treatment onset to resolution of symptoms (maximum of 16 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage	This analysis will be performed in the cohort of subjects whose primary lesion complex is assessed as being in the Prodrome (pain, burning, tingling, itching, redness, swelling, or a tight sensation of the lip), Erythema/Macule, Papule/Edema, or Aborted Stage by the investigator at the first post-treatment visit.	Proportion of subjects in whom the primary lesion complex does not progress will be assessed from treatment onset to resolution of symptoms (maximum of 16 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability	Safety and tolerability of NB-001 following topical administration as assessed by the number and severity of adverse events.	Safety and tolerability will be assessed from treatment onset to study close (expected average of 2 months)

Collaborators and Investigators

• Sponsor: NanoBio Corporation

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ANTICIPATED): July 1, 2013

Study Registration Dates

• First Submitted: September 18, 2012
• First Submitted That Met QC Criteria: September 25, 2012
• First Posted (ESTIMATE): September 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 14, 2013
• Last Update Submitted That Met QC Criteria: June 13, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Herpes, Herpes Labialis, nanoemulsion, NanoBio, NB-001
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Lip Diseases; Herpes Simplex; Herpes Labialis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Adenylyl Cyclase Inhibitors; 5-((2-(6-Amino-9H-purin-9-yl) ethyl) amino)-1-pentanol
• Other Study ID Numbers: NB-001-010