NB-001 Treatment of Recurrent Herpes Labialis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NanoBio Corporation
ClinicalTrials.gov Identifier:
NCT01695187
First received: September 18, 2012
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Herpes Labialis
Drug: NB-001 (0.3%)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 Treatment of Recurrent Herpes Labialis

Resource links provided by NLM:


Further study details as provided by NanoBio Corporation:

Primary Outcome Measures:
  • Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator. [ Time Frame: Time to healing will be assessed from treatment onset to resolution of symptoms (maximum of 16 days) ] [ Designated as safety issue: No ]
    Time to healing is the time from receiving the combination to unlock the medication and begin treatment to investigator assessed healing.


Secondary Outcome Measures:
  • Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Safety and tolerability [ Time Frame: Safety and tolerability will be assessed from treatment onset to study close (expected average of 2 months) ] [ Designated as safety issue: Yes ]
    Safety and tolerability of NB-001 following topical administration as assessed by the number and severity of adverse events.


Enrollment: 362
Study Start Date: October 2012
Estimated Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695187

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

No publications provided

Responsible Party: NanoBio Corporation
ClinicalTrials.gov Identifier: NCT01695187     History of Changes
Other Study ID Numbers: NB-001-010
Study First Received: September 18, 2012
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by NanoBio Corporation:
Herpes, Herpes Labialis, nanoemulsion, NanoBio, NB-001

Additional relevant MeSH terms:
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014