NB-001 Treatment of Recurrent Herpes Labialis

Herpes Labialis Clinical Trial

Official title:

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 Treatment of Recurrent Herpes Labialis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01695187
• Other study ID #: NB-001-010
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 18, 2012
• Last updated: June 13, 2013
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: June 2013
• Source: NanoBio Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 362
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Labialis

Intervention

Drug:
• NB-001 (0.3%)
Topical administration at least five times throughout the day
• Placebo

Locations

Country	Name	City	State
United States	Radiant Research, Inc.	Anderson	South Carolina
United States	Radiant Research, Inc	Chandler	Arizona
United States	Radiant Research, Inc. Chicago	Chicago	Illinois
United States	New River Valley Research Institute	Christiansburg	Virginia
United States	Research Across America	Dallas	Texas
United States	Radiant Research, Inc.	Edina	Minnesota
United States	The Center for Pharmaceutical Research, P.C.	Kansas City	Missouri
United States	Central Kentucky Research Associates, Inc.	Lexington	Kentucky
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Radiant Research, Inc.	San Antonio	Texas
United States	Radiant Research, Inc.	St. Louis	Missouri
United States	Radiant Research, Inc	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
NanoBio Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and tolerability	Safety and tolerability of NB-001 following topical administration as assessed by the number and severity of adverse events.	Safety and tolerability will be assessed from treatment onset to study close (expected average of 2 months)	Yes
Primary	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)	No
Secondary	Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage	This analysis will be performed in the cohort of subjects whose primary lesion complex is assessed as being in the Prodrome (pain, burning, tingling, itching, redness, swelling, or a tight sensation of the lip), Erythema/Macule, Papule/Edema, or Aborted Stage by the investigator at the first post-treatment visit.	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)	No