NB-001 Treatment of Recurrent Herpes Labialis
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Women's Studies |
Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/27/2013 |
Start Date: | October 2012 |
End Date: | July 2013 |
Contact: | Mary R Flack, MD |
Email: | mary.flack@nanobio.com |
Phone: | (734) 302-4000 |
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.
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.
We found this trial at
11
sites
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