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
1 other identifier
interventional
362
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2012
Shorter than P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2012
CompletedFirst Posted
Study publicly available on registry
September 27, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJune 14, 2013
June 1, 2013
8 months
September 18, 2012
June 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage
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 Outcomes (1)
Safety and tolerability
Safety and tolerability will be assessed from treatment onset to study close (expected average of 2 months)
Study Arms (2)
NB-001 (0.3%)
EXPERIMENTALNB-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).
Vehicle
PLACEBO COMPARATORNB-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.
Interventions
Eligibility Criteria
You may qualify if:
- 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;
- 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;
- 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;
- 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;
- Be willing to refrain from participation in another clinical trial;
- Be willing and able to use phone or internet to obtain the combination to unlock their study medication kit;
- Be able to read and write in English and understand and comply with the protocol requirements;
- Be able to give informed consent and have signed a written informed consent form.
You may not qualify if:
- Known hypersensitivity to one of the drug ingredients, including soybean oil, polysorbate (Tween), alcohol, EDTA, or cetylpyridinium chloride (found in some mouthwashes and lozenges);
- Severe chronic illness including renal failure, severe respiratory or cardiac disease, chronic infections, immunodeficiency syndrome, uncontrolled diabetes mellitus or untreated severe thyroid disease;
- Received (within the last 6 months) or receiving chemotherapy;
- 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;
- Previously received herpes vaccine;
- Active alcohol or drug abuse;
- Prior randomization into any NanoBio study;
- Any condition that would potentially make them unable to participate for the entire trial period;
- Known allergies to topical creams, ointments or other topical medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Radiant Research, Inc
Chandler, Arizona, 85224, United States
Radiant Research, Inc
Tucson, Arizona, 85710, United States
Radiant Research, Inc. Chicago
Chicago, Illinois, 60654, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509, United States
Radiant Research, Inc.
Edina, Minnesota, 55435, United States
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, 64114, United States
Radiant Research, Inc.
St Louis, Missouri, 63141, United States
Radiant Research, Inc.
Anderson, South Carolina, 29621, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Research Across America
Dallas, Texas, 75234, United States
Radiant Research, Inc.
San Antonio, Texas, 78229, United States
New River Valley Research Institute
Christiansburg, Virginia, 24073, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2012
First Posted
September 27, 2012
Study Start
October 1, 2012
Primary Completion
June 1, 2013
Study Completion
July 1, 2013
Last Updated
June 14, 2013
Record last verified: 2013-06