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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

Page last updated: August 23, 2015

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