NB-001 Treatment of Recurrent Herpes Labialis
Information source: NanoBio Corporation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Labialis
Intervention: NB-001 (0.3%) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: NanoBio Corporation
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.
Clinical Details
Official title: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 Treatment of Recurrent Herpes Labialis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator.
Secondary outcome: Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
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
Additional Information
Starting date: October 2012
Last updated: June 13, 2013
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