Overview

This trial is active, not recruiting.

Condition herpes labialis
Treatments nb-001 (0.3%), placebo
Phase phase 3
Sponsor NanoBio Corporation
Start date October 2012
End date June 2013
Trial size 362 participants
Trial identifier NCT01695187, NB-001-010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
NB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and two surfactants: polysorbate (Tween) 20 and cetylpyridinium chloride (CPC).
nb-001 (0.3%)
Topical administration at least five times throughout the day
(Placebo Comparator)
NB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and one surfactant: polysorbate (Tween) 20.
placebo

Primary Outcomes

Measure
Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator.
time frame: 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
time frame: 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)

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 Treatment of Recurrent Herpes Labialis
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by NanoBio Corporation.