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

Use our guide to learn which trials are right for you!

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
1156 Bowman Road
Mt Pleasant, South Carolina 29464
843-856-3784
?
mi
from
Mt Pleasant, SC
Click here to add this to my saved trials
515 N. State Street
Chicago, Illinois 60654
312-494-2227
?
mi
from
Chicago, IL
Click here to add this to my saved trials
9 Medical Parkway
Northeast, Texas 75234
281-579-1938
?
mi
from
Northeast, TX
Click here to add this to my saved trials
Chandler, Arizona 85224
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Christiansburg, Virginia 24073
?
mi
from
Christiansburg, VA
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Edina, Minnesota 55435
?
mi
from
Edina, MN
Click here to add this to my saved trials
Greer, South Carolina 29651
?
mi
from
Greer, SC
Click here to add this to my saved trials
Kansas City, Missouri 64114
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Lexington, Kentucky 40509
?
mi
from
Lexington, KY
Click here to add this to my saved trials
St Louis, Missouri
?
mi
from
St Louis, MO
Click here to add this to my saved trials