Clinical trial NCT01695187: NB-001 Treatment of Recurrent Herpes Labialis
Official title: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 Treatment of Recurrent Herpes Labialis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Herpes Labialis
Keywords: Herpes, Herpes Labialis, nanoemulsion, NanoBio, NB-001
Lead sponsor: NanoBio Corporation
Sponsor class: INDUSTRY
First posted: 2012-09-27
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator.
timeFrame: Time to healing will be assessed from treatment onset to resolution of symptoms (maximum of 16 days)
Secondary outcomes:
measure: Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage
timeFrame: 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:
measure: Safety and tolerability
timeFrame: Safety and tolerability will be assessed from treatment onset to study close (expected average of 2 months)
Locations:
city: Chandler
country: United States
facility: Radiant Research, Inc
state: Arizona
city: Tucson
country: United States
facility: Radiant Research, Inc
state: Arizona
city: Chicago
country: United States
facility: Radiant Research, Inc. Chicago
state: Illinois
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Edina
country: United States
facility: Radiant Research, Inc.
state: Minnesota
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, P.C.
state: Missouri
city: St. Louis
country: United States
facility: Radiant Research, Inc.
state: Missouri
city: Anderson
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc.
state: Texas
city: Christiansburg
country: United States
facility: New River Valley Research Institute
state: Virginia
Study officials:
References: